MDR and IVDR

EU Regulation 2017/745 on medical devices and active implantable medical devices (MDR) and Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) introduce safety and vigilance obligations similar to those for pharmaceuticals.

Due to COVID-19, application of the MDR – initially planned for 26 May 2020 – was postponed to 26 May 2021. The IVDR began to be applied on 26 May 2022. Moreover, EU Regulation 607/2023 modified the MDR and IVDR with regard to transitional provisions for certain categories of medical devices and in vitro diagnostic medical devices.

The Italian Parliament adopted Legislative Decree No 137 of 5 August 2022, which adapted Italian legislation to the provisions established by the MDR and replaced Legislative Decree 46/1997 concerning the regulation of medical devices. Further, Legislative Decree No 138/2022 ensured the adaptation of Italian legislation to the provisions of the IVDR. In June 2023, the Italian Ministry of Health published in the official gazette four decrees concerning clinical investigations:

• Ministerial Decree of 12 April 2023 – “Administrative terms of national relevance for the submission of communications relating to clinical investigations for devices with the CE marking used in the context of their intended use as referred to in Article 16, paragraph 3 of Decree No 137 of 2022”;
• Ministerial Decree of 12 April 2023 – “Administrative terms of national relevance for the submission of the application for clinical investigation for medical devices not bearing the CE marking referred to in Article 16, paragraph 2 of Legislative Decree No 137 of 2022”;
• Ministerial Decree of 20 March 2023 – “Provisions for the purpose of ensuring that the persons in charge of assessing and validating clinical investigation applications or of making a decision thereon do not have a conflict of interest, are independent from the sponsor, the investigators involved, and the natural or legal persons financing the clinical investigation, and are free from any undue influence”; and
• Ministerial Decree of 20 March 2023 – “Requirements for facilities suitable for conducting clinical investigations, in compliance with Article 62(7) of Regulation (EU) 2017/745”.

In this context, in May 2023, the EU’s Medical Device Co-ordination Group (MDCG) published an update of “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD” with the goal of providing clarification on the meaning of “significant changes in the design and intended purpose” under Article 120(3c), point b, MDR for legacy devices.

Regulation (EU) 2017/745 provides four risk classes, depending on the intended use and the risks involved:

• class I (containing mainly non-active and non-invasive devices);
• IIa (medium-risk devices such as non-active devices and active devices that interact with the body in a non-hazardous manner);
• IIb (eg, active devices that interact with the body in a dangerous manner); and
• III (eg, implantable devices)

The level of risk associated with each class rises with the numbering, with the lowest risk products in class I and the highest in class III. The medical device’s classification is carried out by the manufacturer according to the criteria established by Annex VIII of Regulation (EU) 2017/745. In October 2021. The MDCG has published its “Guidance on classification of medical devices” in the light of the MDR.

Pursuant to Article 52 of the MDR, before placing a medical device on the market, manufacturers must undertake an assessment of the conformity of that device in accordance with the procedures established by Annexes IX to XI. The conformity assessment procedure may require the intervention of a notified body under the MDR.

A new traceability system was introduced with the so-called Unique Device Identifier code (UDI).

The aforementioned Regulations introduce a new European database of medical devices (EUDAMED) in order to help with sharing, on a single platform, all information related to such devices marketed in Europe. With the Implementing Regulation (EU) 2021/2078, the Commission laid down the detailed arrangements necessary for setting up EUDAMED.

With regard to software-based medical devices, the “MEDDEV 2.1/6 Guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of medical devices”, issued by the EU Commission in July 2016, and the “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR, and Regulation (EU) 2017/746 – IVDR”, issued in October 2019 by the MDCG, apply. Moreover, on 18 October 2023, the MDCG published the “Medical Device Software (MDSW) Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components” (MDCG 2023-4) with the aim of providing clarifications on the qualification of hardware and hardware components (ie, when they should be considered as medical devices, accessories to a medical device or neither of these options).

On 9 July 2024, the EU Regulation 1860/2024 “amending the Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices” was published in the Official Journal of the European Union.

Personal Protection Equipment (PPE)

PPE is designed to be worn or held by an individual for protection against safety hazards. PPE must comply with requirements provided under EU Regulation 425/2016 (PPE Regulation). All PPE must meet Essential Health and Safety Requirements (EHSR) and must be CE marked.

PPE are classified into three risk categories (Annex I of the EU Regulation 425/2016).

Medical Instruments

Medical instruments are a broad category that include surgical instruments, emergency room instruments, invasive and non-invasive medical diagnostics instruments, and, in general, all those instruments used in a medical environment to diagnose, cure, treat, and prevent diseases or help/support such purposes – eg, stethoscopes, electrocardiographs, and syringes.

The intended purpose helps in determining whether a medical instrument is considered a medical device or not. If the instrument was manufactured to be used for one of the medical purposes listed in Article 2(1) MDR or Article 2(2) IVDR, then it is a medical device.

Cosmetics

EU Regulation 1223/2009 concerns cosmetic products. EU Regulations 1099/2021, 1902/2021, and 135/2022, which added further banned substances to the composition of cosmetics, amended it.

Its basic principle is that, to ensure the safety of cosmetic products, a “responsible person” must be designated within the EU to place the products on the market. Such responsible person is usually the manufacturer or a person designated in writing by the manufacturer acting on its behalf.

For cosmetics imported into the EU, the importer is considered the responsible person. The distributor can also be considered the responsible person in specific cases.

Biocides

EU Regulation 528/2012 concerns the availability on the market and use of biocidal products (Biocidal Products Regulation, BPR).

Biocidal products cannot be placed on the market or used without authorisation pursuant to the BPR. National authorisation, an EU-wide authorisation (for certain types of biocides), or a mutual recognition procedure are available.

Active substances in a biocidal product must also be pre-approved.

Transitioning to full implementation of the BPR, products containing active substances currently under review in accordance with BPR requirements can be placed on the market as per Presidential Decree 392/1998 as presidi medico-chirurgici (medical-surgical devices) by submitting an application for a marketing authorisation to the Ministry of Health and National Institute of Health (ISS).

In the case of a breach of the provisions of the BPR, the sanctions provided for in Legislative Decree 179/2021 shall apply.

Food and Nutrition Supplements

Regulation 178/2002 reinforces the rules on safety of food in the EU. The basic principle is that no food dangerous to health or unfit for consumption may be put on sale in the EU.

EU Regulation 1169/2011 establishes general principles, requirements, and responsibilities governing food information and labelling.

Mandatory food information falls into the following categories:

• identity and composition, properties, and other characteristics of food;
• protection of consumers’ health and safe use of a food; and
• nutritional characteristics.

Legislative Decree 231/2017 provides sanctions with respect to violations of EU Regulation 1169/2011.

EU Regulation 625/2017 sets common rules for official controls to ensure that agricultural food chain legislation to protect human health, animal health and welfare, and plant health is correctly applied and enforced.

EU Directive 46/2002 concerns food supplements; it has been implemented with Legislative Decree 169/2004.

The commercialisation of food supplements in Italy is subject to a label notification procedure to the Ministry of Health.

Genetically modified organisms (GMOs) in food are regulated by EU legislation. In particular, EU Regulation 1829/2003 regulates the placing on the market of products intended for food or feed containing GMOs as well as the labelling of products intended for the final consumer, while EU Regulation 1830/2003 establishes a harmonised community system to ensure the traceability and labelling of GMOs and the traceability of products intended for food or feed produced from GMOs.

Pharmaceuticals

Legislative Decree 219/2006 (Medicinal Product Code) provides that medicinal products cannot be placed on the market without an authorisation from the Italian Drug Agency (AIFA) or an EU authorisation from the European Medicine Agency (EMA) in accordance with EU Regulation 726/2004.

No one can manufacture medicinal products on the Italian territory without a manufacturing authorisation from AIFA, issued after an inspection.

The pharmacovigilance “responsible person” must meet certain professional requirements and comply with obligations such as submission of periodic reports on product safety (PSURs). PSURs are not required for generic, homeopathic, traditional herbal medicinal products, or products based on substances which have a well-established medicinal use.

Blood Products

Industrial blood products are medicines produced through industrial manufacturing processes from human blood or plasma derived from voluntary donations. Legislative Decree 261/2007 regulates the quality and safety standards for the collection, testing, processing, storage and distribution of human blood and blood components; in particular, Article 26 concerns the “Production of medicinal products derived from blood or plasma”.

Blood products must obtain a marketing authorisation as per Legislative Decree 219/2006 pursuant to assessment of quality, safety, and efficacy.

Law 219/2005 sets out basic rules for the national production of blood products.

Psychedelics

Decree No 309/1990 (the “Narcotic and Psychotropic Drugs Code”) provides the regulation of narcotic drugs and psychotropic substances, including prevention and treatment of, and rehabilitation from, drug dependence.

According to Article 13 of the Narcotic and Psychotropic Drugs Code, narcotic or psychotropic substances subject to the supervision and control of the Ministry of Health and medicinal products based on such substances, including active substances for pharmaceutical use, are grouped in five tables, annexed to the relevant presidential decree. The Ministry of Health may update these tables.

Subjects intending to cultivate, produce, manufacture, use, import, export, receive for transit, trade, or otherwise possess for trade narcotic or psychotropic substances included in the above-mentioned tables must obtain authorisation from the Ministry of Health.

Supervision of institutions and companies authorised to cultivate, manufacture, use, or trade, and anyone authorised to possess narcotic or psychotropic substances, is exercised by the Ministry of Health through ordinary and extraordinary inspections, in collaboration with the police.

CBD (Cannabidiol)

As one of the active ingredients of cannabis with no psychotropic effect, CBD is not considered illegal, per se. However, cultivation and commercialisation of cannabis-derivative products is, in general, forbidden in Italy, as cannabis and its derivatives (such as oil, resins, and leaves) are included in the tables of narcotic and psychotropic substances of the Narcotic and Psychotropic Drugs Code.

Law 242/2016 allowed the cultivation of a type of cannabis (ie, Cannabis Sativa L) without authorisation, but only in order to obtain certain derivative products which are specifically listed, such as:

• food and cosmetics produced exclusively in compliance with the disciplines of the respective sectors; and
• semi-finished products, such as fibre, sheaves, powders, wood chips, oils, or gasoline, for supplies to industries and artisan activities from different sectors.

The THC content of the cultivation should be lower than 0.2%. In any event, if, following an inspection, the THC content proves to be higher than 0.2% but less than 0.6%, the farmer is exempt from any liability. Except for this limited exemption, cannabis falls under the Narcotic and Psychotropic Drugs Code as a narcotic or psychotropic substance.

Cannabis use (even with a THC concentration of higher than 0.6%) is, however, allowed for certain therapeutic purposes upon non-repeatable prescription and taking into consideration the specific condition of the patient (eg, against chronic pain or pain associated with diseases such as multiple sclerosis).

Clinical Trials

On 31 January 2022, EU Regulation 536/2014 on clinical trials of medicines for human use went into effect. Therefore, the Italian legal system is adapting its regulation on clinical trials. To this end, Law 3/2018 requires the adoption of several ministerial decrees.

In this context, AIFA published on its website, clarifications and templates of documents to be completed in compliance with the Regulation (eg, “principal investigator curriculum vitae”). AIFA also published “Guidance on the assessment by territorial ethics committees of the document referred to in Article 7(1) of Regulation (EU) No 536/2014”, updated on 12 May 2023.

Moreover, with regard to non-profit clinical trials, the Ministerial Decree of 30 November 2021 was finally published in the official gazette in February 2022 and entered into force in March 2022. It allows the transfer of data and results of non-profit clinical trials (ongoing or already ended) for registration purposes.

On 30 January 2023, the Ministry of Health adopted a Decree concerning the definition of criteria for the composition and functioning of territorial ethics committees, and a Decree regarding the determination of the single fee for clinical trials, attendance fees, and reimbursement of expenses for participation in meetings of the national co-ordination centre of territorial ethics committees for clinical trials on medicinal products for human use and medical devices, territorial ethics committees, and national ethics committees.

Medical Apps

Mobile applications are often used in connection with so-called wearable devices. Some of the apps, such as health and lifestyle apps, fall under the category of “mobile health” or “mHealth”. Some of these mHealth apps may qualify as medical devices and will have to be CE marked and follow the MDR.

The fact that an app intended for generic purposes is used in a health-related field is not sufficient to determine that it is a medical device. In general, apps that perform an action limited to storage, archival, communication, and simple search (so-called library functions) are not considered medical devices. The discriminating factor is the “intended purpose”; ie, the app has been intended by the developer to be used for one of the medical purposes listed in the MDR. In such a case, the mHealth app is considered a medical device.

“MEDDEV 2.1/6 Guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of medical devices”, issued by the European Commission in July 2016, and the “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR, and Regulation (EU) 2017/746 – IVDR”, issued in October 2019 by the MDCG, provide indications on the classification of risk class applicable to software and apps based on their characteristics and interactions.

Tele-medicine

On 17 December 2020, “National Guidelines for the provision of tele-medicine services” were approved by the State-Regions Conference. Such guidelines represent, so far, the reference document for implementation of tele-medicine services under the national health system. They list the services that can be provided through tele-medicine, also taking into account cybersecurity profiles and patients’ consent.

On 18 November 2021, the State-Regions Conference adopted a document containing the “Guidelines for the provision of tele-rehabilitation services by the health professions”.

Moreover, the PNRR is promoting the development of tele-medicine services. For instance, on 29 April 2022 the Ministry of Health issued a decree providing the “Organisational Guidelines containing the Digital Model for the Implementation of Home Care”. In addition, in 2022, the National Agency for Regional Health Services (ie, AGENAS) published a public notice aimed at the design and management of the national tele-medicine platform.

On 21 September 2022, the Ministry of Health approved a decree concerning the “Approval of the guidelines for tele-medicine services – Functional requirements and service levels” (published in the Italian official gazette on 2 November 2022).

Wearables

Wearable electronic devices are meant to interact and be worn in contact with the human body. They are part of the broader category of wearables.

Wearables are part of the Internet of Things, and are usually connected wirelessly with other devices (eg, smartphones). The popularity of wearables is due to their use for fitness and well-being purposes.

Whether a wearable is a medical device or not depends on the “intended purpose”, whether it has been intended by the manufacturer to be used for one of the medical purposes listed in Article 2(1) MDR or Article 2(2) IVDR. If this is the case, then the wearable is a medical device and is subject to regulatory approvals, safety requirements and post-market surveillance requirements set forth therein.

Stem Cells

Legislative Decree No 191/2007, implementing Directive 2004/23/EC (Tissues and Cells Directive), regulates quality and safety standards for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells. In particular, Article 9 of Legislative Decree 191/2007, concerning the import and export of human tissues and cells, provides that only authorised tissue establishments (istituti dei tessuti) shall carry out exports of tissues and cells to third countries. Moreover, in this context, Article 10 of the Decree of 10 October 2012 issued by the Ministry of Health on the export of stem cells regulates the export of haemopoietic stem cells for transplantation purposes.

The Decree of 2 November 2015 issued by the Ministry of Health establishes rules for the allogeneic and autologous haemopoietic stem cell collection, storage, and labelling.

Legislative Decree No 16/2010 regulates technical requirements for the donation, procurement, and testing of human tissues and cells, as well as traceability requirements, notification of serious adverse reactions and events, and certain technical requirements for the coding, processing, preservation, storage, and distribution of human tissues and cells.

Such regulations may be subject to change following approval of the Proposal for a Regulation of the European Parliament and the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC.

“Borderline products” are those not easily classifiable since they can be confused with other classes of products. Typical borderline products are devices and medicinal products containing a substance which, if used separately, would be classified as a medicinal product.

To be a medical device, a product must fulfil the definition given by the MDR, which provides two main elements:

• the specific medical purpose; and
• the principal intended action.

The specific medical purpose is as defined in the MDR, while the principal intended action must be achieved through a mode of action other than pharmacological, immunological, or metabolic means.

The function of a medical device is achieved by physical means, including mechanical functions or replacement/support to organs or body functions.

The Medical Device Guidelines (MEDDEV) 2.1/3 Review 3 on “Borderline products, drug-delivery products, and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative” provide clear definitions of pharmacological, immunological, and metabolic means and examples of products that, although borderline, are either medical devices or medicinal products. Moreover, on April 2022, the MDCG published “Guidance on the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices”.

The MDR provides that any device which incorporates, as an integral part, a substance which, if used separately, would be considered a medicinal product and has an action ancillary to that of the device is assessed and authorised in accordance with the MDR.

From a risk class perspective, all devices incorporating a medicinal product with an ancillary function are classified as class III.

A different conclusion on classification of the product is when a device and a medicinal product are placed on the market as a single integral product intended exclusively for use in the given combination and are not reusable (eg, pre-filled syringes, and aerosols containing a medicinal product). The device shall conform to the general safety and performance requirements (GSPR) under the EU declaration of conformity, and an EU certificate issued by a Notified Body is also to be submitted. In July 2021, EMA issued a “Guideline on quality documentation for medicinal products when used with a medical device”.

Neither cosmetics nor food supplements can be considered medicinal products.

Food supplements may contain, as ingredients, substances also used as active ingredients in some medicinal products. The European Commission identified few criteria to distinguish a food supplement from a medicinal product (despite the common ingredient).

Another category of borderline products is medical devices/PPE. The main difference is that the purpose of PPE is to protect the wearer from safety hazards, while the purpose of the medical device is to guarantee, protect, and support the health of a person other than the wearer, namely the patient.

Difficulties concerning the distinction between medicines and food may arise. National authorities are competent to classify a product as medicine or food on a case-by-case basis. The European Court of Justice also plays a major role in defining the criteria for classifying a product as a food, food supplement, or medicinal product.

Medicinal Products

To manufacture medicinal products, the manufacturer must hold a manufacturing licence granted by AIFA. All manufacturing operations must take place at authorised sites.

AIFA grants manufacturing authorisation upon inspection of the site to ensure compliance with good manufacturing practices set by EU Directive 94/2003 (GMPs). The authorisation procedure takes 90 days.

The qualified person (QP) must meet certain educational and professional requirements. The QP guarantees compliance of batches manufactured at the site with applicable laws and conditions imposed by the competent authority.

Medical Devices

Under the MDR, manufacturers must manufacture devices in accordance with the general safety and performance requirements of Annex I. The application for validation of the quality management system must include the name of the manufacturer and the address of its place of business and any additional sites covered by the quality management system, and, if the manufacturer’s application is filed by its authorised representative, the name and address of the authorised representative.

One regulatory compliance person needs to be appointed to check compliance of the manufacturing process with the quality management system before release of a device.

Manufacturers are also subject to certain registration requirements in the UDI Database, the EUDAMED, and the Commission electronic system to obtain the release of a single registration number to identify the manufacturer and, if applicable, its authorised representative or importer.

Competent authorities perform periodic audits of the quality management system of the manufacturer including on-site audits.

Blood Products

Manufacturing sites authorised to produce blood products must have an appropriate size and advanced technology, and can only manufacture those products included in the framework agreements stipulated with regions and provinces.

Manufacturers must demonstrate that validated production and purification processes constantly obtain homogeneous batches, and must guarantee, as far as permitted by technical specifications, the absence of transmissible viral contaminants or pathogens.

Manufacturing sites must keep adequate documentation to go back from the final product to the initial blood donations from which the final blood product derives. Moreover, manufacturing sites for each and any batches of haemoderivatives must be in possession of documentation proving the origin of the plasma treated and used in that specific batch, compliance with GMP and all applicable EU laws and regulations, as well as the positive outcome of the state control.

Law No 118/2022 (Annual Competition Law 2021) introduced some novelties in the regulation of blood medicinal products from national plasma. In particular, the current regulatory framework provides that blood medicinal products must be produced from plasma collected solely by the Italian transfusion services through the voluntary donation of blood and its components. These medicinal products must be aimed at meeting national needs and be used in priority to commercial equivalent medicinal products, taking into account the therapeutic continuity of certain categories of patients. In addition, the processing, fractionation and production establishments may also be located in EU member states or in third countries that are party to mutual recognition agreements and where the plasma collected comes exclusively from unpaid voluntary donors.

Biocides

As part of the move towards full implementation of the Biocidal Products Regulation in Italy (due by 31 December 2024), products that were on the market before the entering into force of the BPR, containing active substances under review in accordance with requirements provided by the new BPR, can still be manufactured and placed on the market in accordance with Presidential Decree 392/1998 and Order of the Ministry of Health of 5 February 1999 as medical-surgical devices (presidi medico-chirurgici).

Production of medical-surgical devices can take place in sites holding a manufacturing authorisation granted by the Ministry of Health.

Production of products with active substances approved in accordance with the BPR are classified as biocides.

Manufacturing sites are subject to inspections and must have appropriate manufacturing process documentation on the quality and safety of the biocidal product.

Cosmetics

EU Regulation 1223/2009 on cosmetic products is the reference law.

The responsible person ensures compliance with obligations of the Regulation in terms of:

• safety;
• compliance with good manufacturing practices; and
• notification to the European Commission prior to placing the product on the market.

The Decree of the Minister of Health of 27 September 2018 sets out procedures for control of the internal market for cosmetic products, of products, manufacturers, compliance with GMPs, and obligation and communication requirements that operators must fulfil according to vigilance and surveillance activities, as per the Regulation on cosmetic products.

PPE

PPE must comply with requirements provided for under EU Regulation 425/2016 (PPE Regulation).

The manufacturer is required to keep technical documentation of the PPE, as per Annex III of the PPE Regulation. The technical documentation shall specify the means used by the manufacturer to ensure the conformity of the PPE with the applicable EHSR in Annex II.

Legislative Decree 17/2019 amended national laws on PPE to make them consistent with the PPE Regulation.

CBD (Cannabidiol)

The Decree of the President of the Republic 309/1990 is the reference law.

Narcotic or psychotropic substances are subject to the supervision and control of the Ministry of Health. Cannabis is allowed for therapeutic purposes upon non-repeatable prescription and considering the specific pathological condition of the patient.

Food and Nutrition Supplements

EU Regulation 852/2004 requires a food operator to notify the appropriate competent authority of each establishment (ie, manufacturing site) under its control, with a view to register it. Food operators shall also ensure that the competent authority always has up-to-date information on establishments, and that the establishments are approved by the competent authority, following at least one on-site visit, when approval is required.

EU Regulation 853/2004 provides that manufacturers of food of animal origin must either register with or obtain a manufacturing authorisation from the competent authority for each establishment.

Legislative Decree 193/2007 identifies the Ministry of Health, the regions, and the local health agencies as the competent authorities for application of EU Regulations 852 and 853 of 2004.

EU Regulation 625/2017 lays down detailed regulations on official controls.

EU Directive 46/2002 on food supplements (as amended by EU Regulation 418/2021) provides that national establishments manufacturing food supplements are subject to prior authorisation by the competent authority (ie, regions, autonomous provinces of Trento and Bolzano, and the health agencies).

Authorisation can be suspended or withdrawn in the case of lack of the requirements listed above.

Inspections can be carried out at any time by the Ministry of Health.

Good manufacturing standards for food supplements are published in the form of recommendations by the Ministry of Health.

There are no legal obligations or any legal requirements regarding corporate social responsibility in Italy, which is a form of self-regulation. However, companies from different sectors have increasingly been investing resources in this field in the last few years, especially those active in sectors having or expected to have a social role and special responsibility towards society at large, such as pharma, healthcare, life sciences, and energy companies.

Nowadays, some companies have become used to disclosing their corporate social responsibility activities in their SEC or other national filings.

In terms of environmental obligations, the reference law in Italy is Legislative Decree 152/2006 as amended by Law Decree 77/2021.

Medicinal products are “special waste” regulated by Decree of the President of the Republic 254/2003. Sanitary waste is basically split into two macro categories of dangerous and non-dangerous sanitary waste. Depending on classification, there are different obligations for the producer of sanitary waste with regards to, for instance, management, traceability, and deposit.

Law 62/2022 (the “Italian Sunshine Act”) introduced provisions on the transparency of relationships between manufacturing companies, subjects involved in the health sector (eg, HCPs) and health organisations. However, it has not become effective yet, pending the official setting up of the telematic public registry on the website of the Ministry of Health.

Medicinal Products

Article 113 of Legislative Decree 219/2006 defines advertising of medicines.

Medicinal products with no national or European marketing authorisation cannot be advertised.

Advertising must be consistent with a summary of product characteristics and must be objective, encouraging rational use of the product, not overstate the properties of the drug, and not be misleading.

Advertising to the public is not allowed, except for over-the-counter (OTC) products or medicinal products that do not require a medical prescription dispensable by a pharmacist (SOP).

It is also forbidden to distribute to the public samples of medicinal products.

By way of example, advertising to the public cannot contain any elements that:

• make a doctor’s consultation or surgery appear superfluous;
• are aimed exclusively or mainly at children; and
• include a recommendation from scientists, healthcare professionals, or persons widely known to the public.

Advertising of medicines to the public must be authorised by the Ministry of Health, with the exception of promotional messages in newspapers or the periodical press that reproduce in full the information of the leaflet, with a possible addition of a picture or graphic representation of the primary or secondary package.

Should the Ministry of Health not provide authorisation within 45 days from application, authorisation is deemed granted.

OTC and SOP medicines

On 20 July 2023, the Ministry of Health issued  new “Guidelines on advertising of OTC and SOP”, which update and replace all previous guidelines applicable to advertising of OTC and SOP. They establish that the social networks that can be used for SOP and OTC advertising – under the conditions set out in the document – are exclusively Facebook, Instagram, YouTube, and TikTok. Therefore, compared to the previous regulation, TikTok is now also permitted. The dissemination of OTC and SOP advertising messages via other social networks has not been permitted so far. With regard to advertising on social networks, the Guidelines require that advertising on social networks must comply with the so-called “static principle”. This implies that certain settings shall be applied so that neither the company owning the OTC (and SOP) nor other subjects can change the advertising message or add reactions to the advertisement. For instance, on Facebook, the “comment” functionality and reactions (ie, emoticons) must be disabled.

Advertising is allowed to HCPs authorised to prescribe or dispense medicinal products and must comply with guidelines adopted by the Ministry of Health, AIFA, and regions. Article 120 of the Medicinal Product Code provides that companies shall file with AIFA the medicines’ promotional materials aimed at physicians before the start of the advertising campaign. Such promotional materials can be provided to the physicians only after ten days from the filing date, and the filing date must be indicated in the promotional material itself. Advertising to HCPs must include a summary of product characteristics, and specify the class, price, and condition of reimbursement by the national health system.

Advertising on the web is subject to rules stated by the Medicinal Product Code integrated by the Guidelines of the Ministry of Health. The general rule is that any information related to medicinal products must be uploaded in a restricted area dedicated to healthcare professionals with credentials.

Guidelines of the Ministry of Health of 20 July 2023 require that the website sections for HCPs are password-protected and accessible only with passwords that will be issued to HCPs after the transmission of their identification data. Moreover, AIFA clarified that specific internet sections reserved for HCPs shall use appropriate means of verifying the user’s real identity. Specific additional constraints and requirements are also set:

• by the Medicinal Product Code (Legislative Decree No 219/2006) as of the distribution of medicinal products and documentation that can be shown and made available to attendees during conferences/congresses;
• by the Agreement between Government Regions of 2 February 2017 for sponsoring of accredited educational events (Continuous Education in Medicine – ECM events); and
• by the Deontological Code of Farmindustria.

Medical Devices

Article 26 of Legislative Decree 137/2022 provides that advertising to the public of customised MDs and medical devices that, according to the law or manufacturer’s indications, can be dispensed only upon a doctor’s prescription, or can only be used with a HCP’s or doctor’s assistance, is forbidden. Article 22 of Legislative Decree 138/2022 establishes the same principles for the IVDs.

Advertising to the public of medical devices different from those stated above is subject to the authorisation of the Ministry of Health, which has a 45-day term from submission of the request to approve or reject the application.

However, on 26 January 2023, the Ministry of Health adopted the following two decrees: “Identification of cases of advertising of medical devices that do not require ministerial authorisation” and “Identification of cases of advertising of in vitro diagnostic medical devices that do not require ministerial authorisation”.

Advertising to HCPs is not subject to authorisation. However, if MD advertising is made on the internet, the websites (or relevant sections) used for such purpose shall be addressed only to HCPs, and users who intend to access such website shall be warned by an appropriate disclaimer that it contains information addressed exclusively to HCPs.

It is prohibited to use text, names, trade marks, pictures, and figurative or other signs that may mislead the user or patient about the device’s intended purpose, safety, and performance (Article 7 of the Regulation (EU) 2017/745 and Article 7 of Regulation (EU) 2017/746).

In relation to advertising through new means of communication (eg, internet, email, and SMS), the Ministry of Health issued the following guidelines:

• Guidelines of 17 February 2010 on advertising of OTC, medical devices, in vitro medical devices, medical-surgical devices (presidi medico-chirurgici), and veterinary medicinal products;
• Guidelines of 28 March 2013 on advertising of medical devices, in vitro medical devices, and medical-surgical devices;
• Guidelines of 20 December 2017 on advertising of medical devices, in vitro medical devices, and medical-surgical devices, with a particular focus on social media (integrated in 2019 for Facebook); and
• Guidelines of 27 September 2017 on the “Use of testimonials in the advertising of medical devices, in vitro diagnostic medical devices, and medical-surgical devices”.

Also in the case of MDs and IVDs, advertising on social networks shall be compliant with the so-called static principle, as specified in the paragraph above.

Biocides

Advertisement of biocides is subject to prior authorisation by the Ministry of Health. In general, manufacturers cannot use or distribute labels and promotional material that are not consistent with the ones approved by the Ministry of Health. The applicant must specify means of diffusion of the advertising message. If the means of diffusion is social media, the Guidelines of the Ministry of Health of 20 December 2017 (as integrated in 2019 for Facebook) apply.

Under Article 72 of EU Regulation 528/2012, any advertisement for biocidal products must include the following sentences: “Use biocides safely. Always read the label and product information before use.”

Any advertisement for a substance classified as hazardous shall mention hazard classes or hazard categories concerned.

In its decision dated 20 June 2024 (C-296/23), the European Court of Justice has established that the indication “skin friendly” in biocidal products’ labelling is forbidden since it may misleading users by minimising possible product-related risks (or even denying their existence).

Cosmetics

Advertising of cosmetic products to the public is not subject to authorisation.

However, EU Regulation 655/2013 provided common criteria for justification of claims used in relation to cosmetic products, including for claims used in advertising messages related to those products. Six principles have been established:

• legal compliance;
• truthfulness;
• evidential support;
• honesty;
• fairness; and
• informed decision-making.

The responsible person must make sure that all advertising messages comply with the six principles.

All advertising messages must comply with Legislative Decree 206/2005 (Italian Consumer Code) with reference to Articles 18–27.

Curative claims are not allowed for cosmetic products.

PPE

Advertising of PPE to the public is not subject to prior authorisation.

All commercial practices and advertising messages must comply with rules set forth by the Italian Consumer Code, with particular reference to Articles 18–27, and with reference to Legislative Decree 146/2007 on misleading and comparative business-to-business advertising.

Advertising is also subject on a voluntary basis to the Code of Marketing Communication Self-Regulation.

Food and Nutrition Supplements

The general food law is EU Regulation 178/2002.

Advertising and presentation of food (including, for instance, shape, packaging, the manner in which they are arranged) and the information that is made available about it, cannot mislead consumers.

EU Regulation 1169/2011 deals with food information to consumers and provides more detailed provisions related to information given to the public and fair commercial communication practices. These “food information practices” are applicable to advertising as well. Food information should not be misleading, nor should it attribute to any food the property of preventing, treating, or curing human disease. On the contrary, food information should be accurate, clear, and easy to understand for the consumer.

All messages must comply with rules set by the Italian Consumer Code (in particular Articles 18–27).

Food supplements are also subject to regulation provided by Legislative Decree 169/2004 implementing EU Directive 46/2002.

In the case of products for which warnings are provided, the advertising message must contain an explicit invitation to read the warnings carefully.

Medicinal Products

Medicinal products cannot be placed on the market without authorisation from AIFA or EMA.

Applicants for marketing authorisation of generic products are not required to submit pre-clinical and clinical data results if it can be proven that the medicinal product is a generic medicine of a reference medicinal product (“originator”) authorised in Italy or at EU level.

Companies must maintain a positive risk-benefit balance for authorised medicinal products at all times, in compliance with pharmacovigilance obligations, including submission of periodic reports on product safety.

Pursuant to Article 112-quarter of Legislative Decree 219/2006 (Medicines Code), online sale of prescription medicines is not allowed. On the other hand, pharmacies and para-pharmacies (as defined in Article 5, paragraph 1, of Law Decree 223/2006 converted, with amendments, into Law 248/2006) can sell non-prescription medicines (SOP) and over-the-counter medicines (OTC) online under certain conditions. In particular:

• pharmacies and para-pharmacies must be authorised by the relevant Italian region or autonomous province or other competent authority and to this end, they must comply with specific information obligations towards the competent authority (eg, name, VAT number and full address of the logistics site); and
• the e-commerce webpage selling the SOPs and/or OTCs must contain:
1. the contact details of the competent authority;
2. a hyperlink to the Italian Ministry of Health website; and
3. the logo attesting that that pharmacy/para-pharmacy has been authorised to sell non-prescription medicines online.

Medical Devices

Medical devices are currently undergoing changes to their legislative framework.

The MDR introduces new requirements and obligations on pre-marketing, marketing authorisation, and post-marketing, such as:

• different classes of risks and pre-marketing steps/approval processes;
• the introduction of EUDAMED; and
• planning, conducting and documenting a clinical evaluation in accordance with Article 61 of the MDR and Part A of Annex XIV of the MDR.

In February 2022, the MDCG published the “Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD”. It addresses the appropriate application of transitional provisions to the so-called legacy devices. In particular, the guidance outlines the activities to be performed by notified bodies as part of the surveillance specified by Article 120(3), second subparagraph, MDR.

Moreover, in May 2023, the MDCG published an updated version of the “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD” (MDCG 2020–3 Review 1).

Article 6 of the MDR and Article 6 of the IVDR allow distance sales of medical devices by means of information society services (eg, online) to natural or legal persons established in the EU. However, the MDR and the IVDR do not provide specific instructions for appropriate distance sales. In this context, the rules regarding online sales established by Regulation EU 2023/988 could be also be applied to medical devices’ distance sales, as regards aspects not regulated by the MDR and IVDR. Indeed, pursuant to Article 2 of the Regulation EU 2023/988: “This Regulation applies to products that are placed or made available on the market insofar as there are no specific provisions with the same objective under EU law which regulate the safety on the products concerned”. Specifically, Article 4 of the Regulation EU 2023/988 provides a definition of “distance sales” – ie “products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at consumers in the Union”, clarifying that it happens when the relevant economic operator directs, by any means, its activities to one or more member states.

Although this Regulation entered into force in June 2023, it will be fully applicable as of 13 December 2024.

In addition, further regulations apply to distance sales, such as Regulation EU 2016/679 (GDPR) for data protection issues and Legislative Decree 206/2005 (the “Consumer Code”) when devices are sold to the consumers.

Biocides

EU Regulation 528/2012 (BPR) concerns the making available on the market, and use, of biocidal products.

A marketing authorisation is required to commercialise biocides in Italy.

An applicant must submit a dossier containing all requirements of Annexes II and III for the biocide and the active substances.

Until full implementation of the BPR, in Italy products containing active substances that are under review in accordance with the BPR requirements can be placed on the market as presidi medico-chirurgici.

PPE

PPE must comply with requirements provided by EU Regulation 425/2016 (PPE Regulation). PPE must meet the Essential Health and Safety Requirements and must be CE marked.

Manufacturers must draw up the technical documentation referred to in Annex III of the PPE Regulation and carry out or have carried out a conformity assessment procedure as per Article 19.

PPE is classified into three risk categories (Annex I).

• Category I – PPE that can be placed on the market by the manufacturer with an EU Declaration of Conformity.
• Categories II and III – PPE that must be pre-evaluated by a notified body that has to issue a Certificate of Conformity, pursuant to which the manufacturer can produce a Declaration of Conformity.

Cosmetics

No marketing authorisation is required to market a cosmetic product in Italy, but, rather, there is a notification requirement prior to placing the cosmetic product on the market to the Cosmetic Products Notification Portal of the European Commission. The responsible person, as identified by EU Regulation 1223/2009, has full responsibilities over the products that are assignable either to pre-marketing/upstream or to post-marketing/downstream phases of a cosmetic product’s life cycle.

The responsible person is also obligated to assure compliant fulfilment of downstream or post-marketing activities such as compliance with labelling requirements, and compliance of the product claims on the labelling and advertising with rules and limits provided by law.

Post-marketing surveillance responsibilities, controls and procedures are as defined by Decree of the Ministry of Health of 27 September 2018. The Ministry of Health oversees compliance with the EU Regulation.

Said Decree requires manufacturers, within 30 days from the start of manufacturing activities at each site, to send a communication to both the Ministry of Health and the region where the site is located with at least the following information:

• name of the manufacturer;
• full address of the site;
• list of cosmetics manufactured at the site; and
• indication of the activities performed at the site (eg, packaging).

Food and Nutrition Supplements

The general food law is EU Regulation 178/2002.

Surveillance of the market is ruled by EU Regulations 852/2004 and 853/2004 dictating strict requirements and rules related, respectively, to hygiene of general foodstuffs and food of animal origins. Manufacturing sites need to be communicated and registered with, or authorised by, the competent authority.

EU Regulation 625/2017 provides specific rules on organisation of official controls.

In Italy, the competent authorities for market surveillance and controls are the Ministry of Health, the regions, and local health agencies.

EU Directive 46/2002 concerns food supplements. Commercialisation of food supplements in Italy is subject to a labelling notification procedure to the Ministry of Health at the time of first commercialisation.

The will and appetite of Italian companies for internationalisation is influenced by different but connected factors such as the size of a company, costs of raw materials, tax regimes and incentives, and labour costs.

Some of these factors can be considered as leading to some level of internationalisation of a company, but do not derive from a planned and robust internationalisation strategy and investment plan, as such. This is often due to a lack of financial and technological resources or lack of adequate management skills and vision.

Depending on the sectors, the regulatory regime might also play a role in determining or influencing internationalisation processes, although companies operating in heavily regulated sectors (eg, pharmaceuticals, and medical devices) and aspiring to sell products globally cannot avoid sticking and complying with strict regulatory rules and controls.

Medicinal Products

A marketing authorisation holder (MAH) must always maintain a positive risk-benefit balance for its authorised medicinal products.

An MAH must possess adequate pharmacovigilance and a risk-management system managed by a pharmacovigilance-qualified person who is an EU resident and in possession of appropriate professional requirements.

An MAH must record all suspected adverse reactions in the EU or third countries, brought to its attention spontaneously by patients or healthcare professionals, or occurring in the context of post-marketing studies.

An MAH must transmit to EudraVigilance (the EU Drug Regulating Authorities Pharmacovigilance system), all adverse reactions in the EU or third countries:

• within 15 days from knowledge of the event for serious suspected adverse reactions; and
• within 90 days from knowledge of the event for non-serious suspected adverse reactions.

An MAH is also required to submit periodic reports on product safety through the EMA’s PSURs repository according to the indication of the marketing authorisation (or for an MA granted before 21 July 2012):

• every six months in the first two years from authorisation;
• once per year in the following two years; and
• every three years afterwards.

CBD (Cannabidiol)

Post-marketing surveillance of suspected adverse reactions to medicinal products based on cannabidiol is co-ordinated by the Superior Institute of Health (ISS) and is carried out through the collection of reports of suspected adverse reactions associated with the administration of named galenic preparations derived from cannabis.

Healthcare professionals who observe a suspected adverse reaction must promptly notify the ISS within two working days from the reaction through the report form on the websites of the ISS, the Ministry of Health, and AIFA.

Medical Devices

MDR and IVDR introduce safety and vigilance obligations similar to that for pharmaceuticals. They have been implemented in Italy respectively by Legislative Decree 137/2022 and Legislative Decree 138/2022.

In particular, Article 10 of Legislative Decree 137/2022 and Article 13 of Legislative Decree 138/2022 establish that further a ministerial decree should be adopted in order to regulate, by way of example, the terms and methods for reporting incidents. In this context, the Ministry of Health issued a circular dated 29 November 2022 on operative instructions about reports for MD and IVDR in case of serious incidents, other types of incidents, complaints, safety corrective actions, and trend reports. This guidance is addressed to economic operators (manufacturer, authorised representative, importer, and distributor) as well as users (eg, healthcare professionals, lay users, and patients).

With regards to the terms and methods for reporting complaints involving MD or IVDR by HCPs, lay users, and patients, the Ministry of Health adopted two decrees on 26 January 2023. According to Ministerial Decrees of 26 January 2023, HCPs of both public and private institutions – as well as healthcare facilities, pharmacies, general practitioners, and paediatricians of free choice – who receive reports of complaints from lay users and patients, must transmit such reports to the Ministry of Health within 30 days.

In addition, on 6 June 2023, the Ministry of Health issued a circular containing “Guidelines for reporting complaints on MD and IVDR”: in this document, the Ministry of Health provides clarification and guidance on the reporting of complaints and the distinction between complaints and incidents.

The Decree of 31 March 2022 issued by the Ministry of Health establishes the national device-vigilance network and an information system to support it.

In accordance with the MDR, manufacturers must establish, document, implement, and update a post-market surveillance system proportionate to the risk class of each device.

If a preventative or corrective action is needed, the manufacturer must implement it and inform the competent authorities and, where applicable, the notified body.

Manufacturers of class IIa, class IIb, and class III devices must prepare a periodic safety update report (PSUR) for each device.

Manufacturers are also required to report to the competent authority (ie, Ministry of Health) the following:

• any serious incident involving devices made available in the EU, not later than 15 days after they become aware of the incident (ten days in the case of death or most serious life-threatening cases); and
• any field safety corrective action of devices made available in the EU before implementing the corrective action (except in cases of urgency).

Following the reporting of a serious incident, the manufacturer must investigate the serious incident and the device concerned. The manufacturer must provide a final report (Manufacturer Incident Report, MIR) to the Ministry of Health, with its findings setting out conclusions and corrective actions needed.

Field safety corrective actions must also be reported to the users of the device by means of a field safety notice (FSN).

In February 2023, the Medical Device Co-ordination Group (MDCG) published the “Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices” (MDCG 2023-3). This document is also contained in the circular adopted by the Italian Ministry of Health on 31 March 2023.

PPE

PPE must comply with the requirements provided for under EU Regulation 425/2016.

The national legal framework has been amended to make it compatible with EU Regulation 425/2016 and with Legislative Decree 17/2019.

In Italy, post-marketing surveillance functions and obligations are performed by the Ministry of Economic Development and the Ministry of Labour.

Biocides

EU Regulation 528/2012 concerns the making available on the market and the use of biocidal products.

The Ministerial Decree of 10 October 2017 defines the responsibilities of the Ministry of Health as the national competent authority for monitoring and control activities referring to subsequent agreement of the Conference of State-Regions (signed on 6 December 2017) to identity the specific competence of regions.

An MAH must keep records of the biocidal products placed on the market for:

• at least ten years after placing on the market; or
• ten years after the date on which the MA was cancelled or expired, whichever is the earlier.

Cosmetics

EU Regulation 1223/2009 is the relevant regulation on cosmetic products.

The basic principle set forth in the Regulation is that a responsible person must be designated within the EU to place the cosmetic products on the market. The responsible person’s obligation includes post-marketing surveillance activities.

The responsible person who considers that a cosmetic product placed on the market is not compliant with the EU Regulation must immediately take the corrective measures necessary to make the product compliant, withdraw it, or recall it, as appropriate.

Where the cosmetic product presents a risk to health, the responsible person must immediately inform the competent authorities of the member states where the product was made available and of the member state where the product information file is readily accessible, detailing the non-compliance and the corrective measures taken.

As for serious undesirable effects, the responsible person (and distributors) must notify the competent authority of the member state (in Italy, the Ministry of Health) where the serious undesirable effect occurred.

Food and Nutrition Supplements

The general food law is EU Regulation 178/2002.

If a food business operator considers that a food it has imported, produced, processed, manufactured, or distributed is not compliant with food safety requirements, it shall (i) immediately initiate procedures to withdraw the food from the market where the food has left the immediate control of that initial food operator, and (ii) inform the competent authorities.

A food operator must immediately inform the competent authorities if it considers that a food it placed on the market may be injurious to human health. Operators must inform the competent authorities of the action taken to prevent risks to the final consumer.

This “traceability” principle leaves to food operators the freedom to determine how best to comply with it in order to identify the batches that are not compliant with safety requirements so as to avoid massive recalls (see also “Agreement of the State-Regions Conference of 28 July 2005 and 5 May 2021 on the National Guidelines for the functioning of a Rapid Alert System of Food and Feed”).

EU Regulation 625/2017 provides specific rules for the organisation of controls. Legislative Decree 27/2021 harmonised national legislation to EU Regulation 625/2017, and indicated the Ministry of Health, the regions, and local health agencies as the competent authorities for controls.

EU Directive 46/2002 specifically concerns food supplements. It was implemented with Legislative Decree 169/2004, which also provides for a vigilance annual plan to be agreed by the Ministry of Health in collaboration with the State-Regions Conference.

The Italian regulatory authorities are as follows.

• Medicinal products:
1. Ministry of Health;
2. Italian Drug Agency (AIFA); and
3. European Medicine Agency (EMA).
• Medical devices: Ministry of Health (Directorate of Medical Devices and Pharmaceutical Services).
• Blood products:
1. Ministry of Health; and
2. Italian Drug Agency (AIFA).
• CBD:
1. Ministry of Health; and
2. Superior Institute of Health (ISS).
• Personal Protection Equipment:
1. Ministry of Economic Development; and
2. Ministry of Labour.
• Food and nutrition supplements: Ministry of Health.
• Biocides:
1. Ministry of Health;
2. European Chemicals Agency (ECHA); and
3. the EU Commission.
• Cosmetics: Ministry of Health.

Medicinal Products

Ministry of Health

The Ministry of Health is in charge of general guidelines and vigilance of the activities of AIFA.

AIFA

AIFA oversees assessment, review, authorisation, supervision, monitoring of the development, manufacturing, price and reimbursement conditions, promotion, and sale of medicinal products.

By way of example, AIFA is responsible for the following activities:

• granting national manufacturing authorisation;
• granting marketing authorisation;
• negotiation and determination of sale price and reimbursement conditions;
• inspections/audits; and
• suspension or withdrawal of the manufacturing authorisation.

EMA

The European Medicine Agency (EMA) is responsible for the scientific evaluation, supervision, and control of the safety of medicinal products at EU level.

It is responsible for reviewing EU-centralised marketing authorisations for the following product categories:

• biotech drugs;
• new active substances for specified diseases;
• orphan medicinal products;
• advanced therapy medicinal products; and
• is optional for other substances that are:
1. a significant therapeutic, scientific, or technical innovation; and
2. in the interest of public health at EU level.

Two key committees within the EMA are:

• the Committee for Medicinal Products for Human Use; and
• the Pharmacovigilance and Risk Assessment Committee.

The Commission has authority to grant, refuse, vary, suspend, withdraw, or revoke a marketing authorisation, and impose penalties for non-compliance with the obligations relevant to marketing authorisations.

Medical Devices

The Ministry of Health (Directorate of Medical Devices and Pharmaceutical Services) has supervision and surveillance powers over a medical device’s safety and conformity with applicable laws and regulations.

The Ministry can:

• order withdrawal/recall from the market;
• impose a sales ban;
• prevent placing of the device on the market or into service; and
• issue orders and corrective actions to manufacturers for ascertained non-conformity of their products with sanctions in the case of non-compliance.

The Ministry is the addressee of any communications from the manufacturer of incidents involving a medical device and any communications from healthcare institutions and healthcare professionals.

The Ministry is responsible for qualifying and authorising applicants as approved notified bodies and supervises the notified bodies and legal requirements.

The Ministry is also empowered to carry out announced/unannounced inspections and audits to sites and warehouses.

PPE

The Ministry of Economic Development and the Ministry of Labour and Social Policies are responsible for surveillance of the PPE market. For instance, they:

• carry out safety evaluation of PPE if they believe there is a risk to health or safety;
• require manufacturers to provide all information and documentation to demonstrate the conformity of PPE with the PPE Regulation; and
• apply sanctions in the case of non-compliance.

Food and Nutrition Supplements

By way of example, the Ministry of Health is empowered to:

• register or authorise manufacturing sites, as applicable;
• carry out investigations and controls with local competent authorities, and inspections, usually unannounced, of establishments; and
• order the recall, withdrawal, removal, and destruction of goods.

National establishments manufacturing food supplements are also subject to prior authorisation and surveillance by the competent authority as identified in Law 189/2012 (ie, the regions and local health agencies).

Cosmetics

By way of example, the Ministry of Health, as the Italian competent authority, is empowered to:

• oversee compliance with EU Regulation 1223/2009 with the collaboration of the regions and autonomous provinces;
• require the product information file of the cosmetic product from the manufacturer;
• collect the data of the activities and inspections carried out by the regions and autonomous provinces; and
• order withdrawal or recall of the cosmetic product from the market.

Biocides

The General Directorate of Medical Devices and Pharmaceutical Services of the Ministry of Health drafts and approves the Annual National Control Plan on biocides, based on data, information, and results of controls and surveillance made at a local level in the territory.

The Ministry is empowered to control conformity of biocides with the BPR.

The Ministry of Health is empowered to grant marketing authorisations at national level to local applicants and amend or cancel any such authorisations. As for products containing active substances under review in accordance with BPR requirements and that can be placed on the market in accordance with Presidential Decree 392/1998 as presidi medico-chirurgici, the national application for marketing authorisation is reviewed and approved by the Ministry of Health and the National Institute of Health.

Medicinal Products

By way of example, typical product safety offences are:

• promotion and sale of a medicinal product without marketing authorisation or with a suspended or revoked marketing authorisation;
• production of medicinal products without manufacturing authorisation or with a suspended or revoked authorisation;
• promotion of the medicinal product outside approved indications; and
• production and distribution of falsified or illegal products.

Offences can represent either criminal or administrative offences, with a different regime of sanctions/penalties.

Criminal sanctions are issued against individuals, although certain criminal offences may trigger corporate criminal liability, pursuant to Legislative Decree 231/2001.

Medical Devices

By way of example, typical product safety offences are:

• lack of compliance with essential requirements and non-conformity with the CE marking;
• placing on the market or putting into service of a medical device without a CE mark or certification of conformity; and
• lack of reporting of incidents to the Ministry of Health by healthcare organisations and/or healthcare professionals.

Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

PPE

By way of example, typical product safety offences are:

• manufacturing or placing on the market by the manufacturer or importer PPE not compliant with essential health and safety requirements;
• placing of PPE onto the market without the EU declaration of conformity; and
• putting unclear, misleading, or confusing marks, signs or other inscriptions on the PPE.

Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

Cosmetics

By way of example, typical product safety offences are:

• violations of safety requirements and obligations by manufacturing, possessing, or placing onto the market of cosmetics dangerous to consumers’ health;
• lack of compliance by the responsible person with his or her market surveillance duties and lack of implementation of remedial actions; and
• lack of compliance with GMPs.

Legislative Decree 204/2015 established the regulatory regime applicable to the provisions of EU Regulation 1223/2009.

Offences can represent either criminal or administrative offences, with a different regime of sanctions/penalties.

Biocides

By way of example, typical product safety offences are:

• placing onto the market or use of a biocide without authorisation in accordance with the BPR;
• lack of compliance of the classification, packaging, and labelling of the biocide with the requirements of the summary of biocidal product characteristics; and
• violation of the notification obligations of unexpected or adverse effects.

Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

Criminal sanctions are issued against individuals, although certain criminal offences may trigger corporate criminal liability pursuant to Legislative Decree 231/2001.

A scheme of legislative decree for adoption of the regulatory regime related to the application of the BPR is currently under evaluation and discussion in the Italian Parliament, pursuant to Law 117/2019. Criminal and administrative sanctions for violations of the biocide requirements are currently set forth in Legislative Decree 174/2000.

Food and Nutrition Supplements

By way of example, typical product safety offences are:

• violation of obligations of withdrawal from the market of food not compliant with food safety requirements;
• lack of, or refusal to, collaborate and provide data and information required by the competent authority; and
• violation of the obligation to inform those consumers who have acquired the product of any withdrawal/recall of food products.

Legislative Decree 190/2006 established the regulatory regime applicable to EU Regulation 178/2002. Offences can represent either criminal or administrative offences.

Typical product safety offences for food supplements are, for instance:

• manufacturing and packaging of food supplements without manufacturing authorisation;
• placing on the market food supplements without prior labelling notification to the authority; and
• violations of the obligations related to labelling, presentation, and advertising of supplements.

Legislative Decree 169/2004 established the regulatory regime applicable to the provisions of EU Directive 46/2002. Offences can represent either criminal or administrative offences, with a different regime of sanctions/penalties.

EU Directive 374/85 on General Product Liability was implemented in Italy with Presidential Decree 224/1988, and subsequently incorporated into Legislative Decree 206/2005 (the Consumer Code).

The Consumer Code provides a strict liability that can be claimed by consumers for damages caused by a defective product. This liability is alternative to contractual and tortious liabilities governed by the Civil Code.

Article 2043 of the Italian Civil Code sets the tortious liability to be based on the duty of care concept.

Article 2050 of the Italian Civil Code provides for strict liability (ie, presumption of liability) for those who exercise a per se dangerous activity.

Under the Consumer Code, the manufacturer is the first subject liable for damages caused by a defective product.

The distributor may also, residually, be held liable in cases where the manufacturer is not identified.

The manufacturer can escape liability if it is able to demonstrate that the defect, the damage, or the casual link does not exist.

As usual the reality is a step ahead of the legislative process. New technologies such as AI, generative AI, and machine learning have opened new and largely still unexplored territories also regarding product liability, even more if such technologies are applied to the healthcare/life sciences sectors which deal with the health of patients (eg, machine learning applied to diagnostics procedures).

While at the local level we register an effort to stretch and apply the existing product liability legislative tools to new technologies, at EU level, the European Commission has been working on a comprehensive legislative framework to rule these new and futuristic technologies. The EU Commission’s proposal for a Regulation on AI (known as the AI Act) has been recently approved by the European Parliament (14 June 2023) triggering the consultation procedure at trilogue level. Moreover, on 28 September 2022 the European Commission proposal on a new Directive on liability for defective products (Product Liability Directive) as well as a proposal for a Directive on adapting non-contractual civil liability rules to artificial intelligence (AI liability Directive) have been published.

Jurisdiction over disputes related to personal rights between private parties or private/public parties lies with the Ordinary Civil Courts:

• lower courts (Giudice di pace) for minor and low value claims;
• civil tribunals for first instance;
• Courts of Appeal for second instance; and
• the Supreme Court as the third and final instance.

Within the ordinary civil courts there are specialised sections, the tribunals of enterprises specialised in disputes over specific business matters and intellectual property rights.

Administrative courts have jurisdiction over disputes around the legitimate interests of individuals or people vis-à-vis the acts, orders, and determinations of public administrations:

• Regional Administrative Tribunals (first instance administrative courts); and
• the Council of State (Consiglio di Stato, the administrative Court of Appeal located in Rome).

The Italian Constitutional Court has jurisdiction over, by way of example, cases of constitutional legitimacy of laws, acts having force of law of the state, and the regions.

The judge orders the losing party to refund the legal costs in favour of the counterparty and quantifies them usually on a fixed basis, based on the amounts provided for by Ministry Decree 55/2014.

In doing so, usually the judge excludes costs deemed excessive or unjustified.

However, the judge may also decide to compensate, fully or partially, the costs between the parties.

Acts, decisions or determinations of public administrations affecting legitimate interests of individuals can be challenged before the administrative courts. The regional administrative tribunal of Lazio (TAR Lazio) has jurisdiction over acts and decisions of AIFA and of the Ministry of Health. Decisions of administrative tribunals can be appealed before the Council of State (Consiglio di Stato).

There are many examples where the determinations/decisions of AIFA have been challenged in court by pharmaceutical companies (eg, legal actions versus the pay-back, the legal mechanism requiring all pharmaceutical companies to pay back to regions the over-expenditure of reimbursed medicinal products vis-à-vis the budget allocated to them). Other contentious areas are price negotiation and reimbursement conditions of medicinal products.

Class actions are litigations where a large group of plaintiffs is considered a class and is represented by an individual “class representative”. The class representative stands in court for the class and all members are treated as one plaintiff.

In May 2021, a new regulation for class action was introduced. It is now incorporated into the Italian Code of Civil Procedure and abrogated relevant measures on class action that were included into Legislative Decree 206/2005 (Italian Consumer Code). The new regulation is applicable to the illicit conducts committed after its entry into force; for conducts that occurred before (ie, prior to 18 May 2021), the old regulation of the Consumer Code will continue to apply.

Pursuant to Italian legislation, individual homogeneous rights can be protected by means of a class action. Entities entitled to initiate a class action to seek compensation for damages or restitution are:

• each individual/consumer member of the class; and
• consumers’ associations and/or not-for-profit organisations having as statutory objective the protections of rights violated, provided that the class action is to protect “individual homogeneous rights” and that such associations and organisations are registered in a public list held by the Ministry of Justice.

Proceeding on the merit is subject to a preliminary filter of the admissibility of the demand.

Unlike the US, where an “opt-out” mechanism is adopted, Italian legislation provides for an “opt-in” mechanism to join a class action. If the action is considered admissible by order of the judge, a term between 60 and 150 days from the date of the publication of the order is granted to allow other members of the class to “opt-in”.

ADR mechanisms available are:

• amicable settlement;
• judicial or extra-judicial conciliation;
• arbitration; and
• mediation with the help of an independent and impartial person.

Product liability cases might also entail a criminal liability, especially in cases where the harmful event is caused by lack of quality or compliance with safety requirements, either intentionally or due to negligence. In particular, for categories of goods that are strictly related to health and aimed at safeguarding the health and safety of the users and patients, a civil liability or administrative dispute can flow into a criminal investigation.

The Next Generation EU Plan triggered the adoption by the Italian government of the National Recovery and Resilience Plan (PNRR). Among many areas of planned interventions, the PNRR is providing for investments to modernise the technological base of Italian hospitals. The investment involves:

• the digital modernisation of the existing technologies whose obsolescence is five years beyond their normal life cycle through the purchase of 3,133 new items of high-tech equipment (eg, CT scanners); and
• interventions aimed at enhancing levels of digitalisation of hospitals.

This modernisation and digitalisation should have a positive impact on the environment, as well as on the health and safety of patients.

On 22 December 2023, the Regulation (EU) 2023/2854 on harmonised rules on fair access to and use of data and amending Regulation (EU) 2017/2394 and Directive (EU) 2020/1828 (the “Data Act”) was published in the Official Journal of the European Union; it will become applicable on 12 September 2025. The main purpose of this Regulation is to establish a harmonised legal framework defining who is entitled to use product data or related service data, under which conditions and on what basis, so as to remove barriers to a well-functioning internal market for data (Recital 4).

On 26 April 2023, the European Commission adopted a proposal for a new Directive and a new Regulation with the aim of reforming EU pharmaceutical legislation (ie, the existing general pharmaceutical legislation and the legislation on medicines for children and for rare diseases).

The actual impact and the possible applications of AI on the health sector are still unknown, as is its full potential. AI is already influencing and helping better diagnostics in the medical imaging field as well as starting to play an important role in predictive medicine.

As discussed in 4.2 Product Liability, current legislation is being stretched to encompass AI.

On 12 July 2024, the Regulation (EU) 2024/1689, laying down harmonised rules on artificial intelligence (the “Artificial Intelligence Act”), was published in the Official Journal of the European Union. The main purpose of this Regulation is to ensure the safe use of artificial intelligence in the EU internal market, so as to guarantee the protection of people's fundamental rights. At national level, Bill No 1146 on artificial intelligence is currently being examined in the Italian parliament. Moreover, the Agency for Digital Italy (Agenzia per l’Italia Digitale) published a document called the Italian Strategy for Artificial Intelligence 2024–2026.

The impact of the EU legislation on medical devices could be huge and also poses some concerns in terms of co-ordinating the existing MDR and IVDR with the AI Act.