Healthcare: Medical Devices 2023 Comparisons

Medical Devices

Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR) is applicable.

In accordance with MDR:

• medical devices (MD) must be CE marked;
• MD manufacturers must draw up a Declaration of Conformity and the MD must also carry the information requested in the MDR. Furthermore, depending on the MD classification, a Notified Body may or may not be involved in the assessment of the Declaration of Conformity.

Royal Legislative Decree 1/2015 of 24 July 2015, approving the revised text of the Spanish Law on guarantees and rational use of medicines and medical devices, is also applicable, as the main national legal framework governing MD.

It is also applicable the recent Royal Decree 192/2023, of 21 March 2023 on medical devices (Spanish Decree on MD), which covers, amongst other matters:

• the determination of the competent authority for the purposes of the MDR;
• the health guarantees of the MD;
• the language regime for the MD; and
• the regulation of procedures for the manufacture of MD for use in the healthcare facility itself and for the reprocessing of single-use MD and their use.

PPE

Regulation (EU) 2016/425 of the European Parliament and of the Council, on personal protective equipment (PPE) is applicable.

In accordance with PPE Regulation:

• PPE must be CE marked;
• PPE manufacturers must draw up an EU Declaration of Conformity and the PPE must also carry the information indicated in the PPE Regulation such as manufacturer’s data, product identification (batch number), instructions and information, etc; and
• PPE is categorized as Category I, II or III depending on the risk it is protecting against.

In the case of Category II or III PPE, before the CE marking is affixed, a Notified Body intervenes during the Declaration of Conformity assessment procedure. Such a body will carry out an EU-type examination and issue an EU-Type Examination Certificate (module B).

PPE manufacturers must also have a manufacturing control process, the details of which vary depending on the category of PPE.

In Spain, Royal Decree 773/1997 of 30 May 1997 on minimum health and safety provisions concerning the use by workers of personal protective equipment is a general regulation applicable to all workers, not just health professionals.

As a final remark, products intended for use as MD, as well as for PPE, must comply with the regulations applicable to both types of products.

Medical Instruments

Medical instruments are subject to the MDR, as they fit into the MD definition.

Medical instruments are, on many occasions, reprocessed, and therefore the Spanish Decree on MD should be referenced, as it deals with the so-called “reprocessing of single-use products”. In such legislation, it is stated that reprocessing can only be carried out by the following entities:

• Natural or legal persons to make single-use products suitable for use in the EU. They have to comply with the obligations of manufacturers under the MDR and the Spanish Decree on MD, which are, amongst others: (i) obtaining a prior activity licence; (ii) reprocessing must be carried out by themselves and cannot be outsourced; (iii) entering into a contract with the hospital specifying responsibilities on storage, return, vigilance, traceability, etc; and (iv) ensuring destruction at the end of the last life cycle of the MD.
• Hospitals (but not by health care facilities as stated in Article 17 of MDR). They have to comply with the following conditions: (i) they may only reprocess used MDs within the hospital itself or by itself or through a third party under its licence; (ii) they may not sell or deliver reprocessed products to third parties; (iii) they can outsource the reprocessing to an external reprocessor carrying out the request of a hospital.
• External reprocessors reprocessing single-use products at the request of a hospital, as per MDR.

Cosmetics

Regulation 1223/2009 of the European Parliament and of the Council on cosmetic products (the “Regulation on CP”) sets out the regime for the CP, by imposing certain safety requirements for their use under normal conditions. Some such requirements are the following:

• CP presentation, which must comply with Directive 87/357/EEC on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers;
• labelling; and
• instructions for use and disposal.

Moreover, the Regulation on CP strengthens certain elements of the regulatory framework for cosmetics, such as in-market control, with a view to ensuring a high level of protection of human health.

From a national perspective, Royal Decree 85/2018, of 23 February on cosmetic products, is also applicable, and this sets out additional measures for public health protection to be taken by the local competent health authorities (in this case, the Spanish Agency for Medicinal Products and Medical Devices or AEMPS, and competent authorities of the autonomous communities) who may, at any time, ask the agents involved to implement the corrective measures they deem necessary, and even, in more serious cases, to recall products and even withdraw permits and licences to manufacture or import CP.

Biocides

Regulation 528/2012 of the European Parliament and of the Council of 22 May 2012, concerning the availability on the market and use of biocidal products, envisages that a high level of protection of human health will be ensured by strengthening certain regulatory elements, while simplifying, on the other hand, certain bureaucratic procedures.

The Spanish legal framework is contained in the Royal Decree 1054/2002 of 11 October 2002, on the process of evaluation for registration, authorisation and commercialisation of biocides. This establishes (with certain exceptions for low-risk products) that biocides can be commercialised in Spain only once they have been authorised and registered by the competent authority.

Food Supplements

Food safety general legislation is very widely regulated in Spain, covering different areas: (i) ingredients and processing aids; (ii) storage, preservation and transport; (iii) trade; and (iv) authority monitoring mechanisms.

Focussing on food supplements (FS), and from a national perspective, Royal Decree 1487/2009, of 26 September 2009 on FS, transposed Directive 2002/46/EC. It relates to vitamins and minerals and other nutrients used by consumers to complete nutrient intake. In particular, it deals with the composition and labelling requirements applicable to food supplements and it is applicable to companies involved in the manufacturing, transformation, packaging, storage, distribution, importation and marketing of food supplements.

Pharmaceuticals

Directive 2001/83/EC of the European Parliament and of the Council and Regulation 726/2004 of the European Parliament and of the Council constitute the basis of pharmaceutical legislation, and they lay down provisions related to medicinal product authorisation and post-authorisation requirements, pre-authorisation support schemes, regulatory incentives in terms of data and market protection, manufacturing and supply, and the European Medicines Agency (EMA). This main pharmaceutical legislation is complemented by specific legislation on medicinal products for rare diseases (Regulation 141/2000), medicinal products for children (Regulation 1901/2006) and advanced therapy medicinal products (Regulation 1394/2007).

In Spain, Royal Legislative Decree 1/2015, of 24 July 2015, approving the revised text of the law on guarantees and rational use of medicines and health products, is applicable.

There is also additional national legislation governing, among others, the following issues.

• Registration of medicinal products, being the most relevant the Royal Decree 1345/2007 of 11 October 2007, regulating the procedure for the authorisation, registration and conditions of dispensing of industrially manufactured medicinal products for human use.
• Pharmacovigilance of medicinal products for human use, the most relevant being the Royal Decree 577/2013, of 26 July 2013, regulating the pharmacovigilance of medicinal products for human use.
• Clinical trials on medicinal products for human use, the most relevant being the Royal Decree 1090/2015, of 4 December 2015, which regulates clinical trials with medicinal products, the Ethics Committees for Research with medicinal products and the Spanish Clinical Trials Register.
• Availability of medicinal products in special situations governed by Royal Decree 1015/2009, of 19 June 2009, regulating the availability of medicines in special situations.
• Magistral Formulation, governed by Royal Decree 175/2001, of 23 February 2001, approving the rules for the correct preparation and quality control of magistral formulae and officinal preparations.
• Narcotic drugs and psychotropic drugs, the most relevant being the Law 17/1967, of 8 April 1967, on narcotic drugs.
• Sale through websites governed by Royal Decree 870/2013, of 8 November 2013, regulating the online sale of medicinal products for human use, not subject to medical prescription, to the public, through websites.

Blood Products

European legislation affecting blood products is currently being revised by the proposal for Regulation of the European Parliament and of 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, dated 14 July 2022.

In Spain, there is additional legislation applicable to this type of product, among which the following can be highlighted:

• Royal Decree 1088/2005, of 16 September 2005, establishing the technical requirements and minimum conditions for haemo donation and transfusion centres and services; and
• Resolution from the Spanish Medicines Agency, of 23 May 2013, establishing the classification of the non-replacement therapeutic use of autologous plasma and its fractions, components or derivatives, as a medicinal product for human use to meet special needs.

Psychedelics

Narcotic drugs are subject to the legislation for pharmaceuticals referred to above.

Besides, from the Spanish legal perspective, legislation is focused on the control of narcotics.

• Law 17/1967, of 8 April 1967, updating the current regulations on narcotic drugs and adapting them to the provisions of the 1961 United Nations Convention.
• Royal Decree 1675/2012, of 14 December 2012, regulating official prescriptions and special requirements for the prescription and dispensing of narcotic drugs for human and veterinary use.
• Royal Decree 2829/1977, of 6 October, regulating psychotropic medicinal substances and preparations, as well as the control and inspection of their manufacture, distribution, prescription and dispensation.
• Royal Decree 1194/2011, of 19 August 2011, establishing the procedure for a substance to be considered a narcotic drug at the national level.

Cannabidiol (CBD) When Used for Medicinal Purposes

CBD is subject to the legislation for pharmaceuticals referred to above when CBD is incorporated into a medicinal product.

The European Union Court of Justice, by decision taken on 19 November 2020, held that CBD was not a narcotic. As a consequence, at European-level legislation, natural CBD was included in the list of ingredients allowed for cosmetics and novel food applications.

In Spain, therapeutic use of CBD is not yet regulated, although legislative initiatives are currently underway.

Medical Apps and Wearables

As far as they fit into the definition of MD, any medical app or wearable is subject to legislation on MD referred to above.

These products are to be in compliance with other EU and Spanish legislation which is applicable to such medical apps:

• General Data Protection Regulation (GDPR);
• Organic Law 3/2018, of 5 December 2018, on Personal Data Protection and Guarantee of Digital Rights; and
• Law 41/2002, of 14 November 2002, a basic law regulating patient autonomy and rights and obligations regarding clinical information and documentation.

Telemedicine

There is no specific legislation in Spain dealing with telemedicine. There are only some references in the Medical Ethics Code issued by the Spanish Medical Association.

The Medical Ethics Code establishes that medical clinical practice by means of consultations made exclusively by letter, telephone, radio, press or internet is contrary to medical ethical standards. Correct practice inevitably involves direct, personal contact between doctor and patient.

Nevertheless, the Code considers that it is ethically acceptable, in the case of second opinions and medical reviews, to use e-mail or other non-face-to-face means of communication and telemedicine, provided that mutual identification is clear and privacy is ensured.

However, due to COVID-19, the use of Telemedicine is now widespread and the agents involved are calling for specific regulation to ensure that, while using telemedicine, the quality standard of patient care is maintained and that data confidentiality and patient autonomy are duly safeguarded.

Stem Cells

In Spain, Law 14/2007, on Biomedical Research, states in its preamble that, in the pursuit of therapeutic or research purposes, the utilisation of any technique for obtaining human stem cells is authorised. Moreover, it establishes the ethical principles that must guide research, the procedures for authorisation and evaluation of research projects, and the use of biological samples, amongst other aspects.

Although the Law 14/2006, on Assisted Human Reproduction Techniques, primarily focuses on assisted reproduction, it also regulates the use of stem cells in the context of reproductive medicine and embryo research.

Royal Decree-Law 9/2014 establishes the quality and safety standards for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells and approves the co-ordination and operational rules for their use in humans.

Medicines and Medical Devices

In April 2022, the European Medical Device Co-ordination Group issued “Guidance on borderline products between MD and medicines products under MDR” (the “Guidance”) which, while not reflecting the European Commission official position, and not being competent to classify products, is, at least, a practical guide to classify borderline products as medicines or MD.

The main problem lies with the identification of the regulatory status of the combination of a medicinal product and a MD.

The Guidance advises that when deciding on the regulatory status of a product combination, two aspects are to be considered.

• The first step is establishing whether the product under consideration is an integral product (a single integral product consists of at least two constituent parts, one of which is a device and the other a medicinal product, which are combined in such a manner that they are not intended to be separated prior to administration).
• As a second step, it should be determined if the action of the medicinal product incorporated in the device is principal or ancillary to that of the device part of the integral product.

If the principal intended action of the integral product is achieved by the medicinal product part, then the entire product is regulated as a medicinal product. However, if the principal intended action is achieved by the medical device part, the entire product is regulated as an MD incorporating a medicinal product that has an action ancillary to that of the device.

It will be the criteria of the AEMPS that will be relevant for the final classification between medicine and MD.

Personal Protective Equipment and MDs

In the case of MD and PPE, when products are intended for use as an MD and PPE, they must comply with the regulations applicable to both of them.

Medicines and Food Supplements

Food supplements fall under the competence of the Spanish Agency for Food Safety and Nutrition (AESAN), and in cases where some of these products have components in common to some medicinal products, the criteria to be used by the authorities to classify them as medicinal products or food supplements is based on their strength, properties or purpose.

Other Cases

In relation to other product classification difficulties affecting human or veterinary medicinal products, MDs, cosmetics, biocides and personal care products, it must be considered that all of them fall under the responsibility of the AEMPS, and therefore, it will be the criteria of this agency that will be relevant for their classification.

Manufacturing, Importing and Related Activities

All economic agents engaged in the manufacture, importation, packaging or sterilisation of medical devices and the facilities where such activities are carried out shall require a prior operating licence. This also applies to devices and instruments used in permanent or semi-permanent make-up or tattooing of the skin using invasive techniques, as well as to the non-medical products listed in Annex XVI MDR.

An import licence is required both for importers established in Spain who introduce a product from a third country into the EU (regular importer), and for those economic agents which are not considered importers in accordance with MDR but physically import a product into Spain (physical importer).

The prior operating licence shall also be required for those economic agents who carry out the complete manufacture of products for third parties. Complete manufacture means the entire manufacturing process, from raw materials until final product. Those subcontractors that carry out a non-substantial phase during the manufacturing process do not require a prior operating licence, as they are included in the operating licence of the manufacturer that is subcontracting such phase.

All these licences are granted by the Spanish Agency for Medicinal Products and Medical Devices (AEMPS).

The same licence shall cover the activities and the facilities where such activities are carried out.

All licences shall be valid for a period not exceeding five years and may be renewed prior to their expiry, if all the requirements are verified.

Any modification of the conditions under which the licence was granted must be authorised in advance by the AEMPS.

Licence Requirements

• A quality management system capable of guaranteeing the quality of the products and the implementation of the procedures and controls as appropriate must be in place.
• Facilities, procedures, equipment and personnel appropriate to the activities and products concerned must be in place.
• A technical manager, with an adequate qualification according to the products that they are in charge of, who will directly supervise the activities, must be hired.
• A documentary archiving system to store the documentation generated with each product must be in place; such system must be maintained to guarantee traceability.
• Declaration of the subcontractors, a description of the activities and the means subcontracted, the corresponding contracts and the procedures used. Such subcontractors must have proper facilities, procedures, equipment and personnel and have a quality management system in place.

Custom-Made Products and Products Manufactured by Hospitals for Their use Only (In-house Manufacturing)

Custom-made product manufacturers must have a prior operating licence, granted by the competent regional health authority.

A recent development in Spanish legislation is the possibility for hospitals to manufacture their own medical devices under the following conditions:

• hospitals cannot manufacture class IIb, class III and implantable products;
• hospitals cannot subcontract this manufacturing;
• manufactured products cannot be sold to the general public nor sold or delivered to third parties. The products are to be used by the hospital only, with no commercial use or alternative; and
• hospitals must previously notify the AEMPS, designating a person responsible for the manufacturing.

Besides mandatory environmental regulations (eg, waste control and management), which are applicable to any product, there are no specific obligations regarding corporate social responsibility throughout the product life cycle applicable to medical devices and consumer health products.

That said, all companies with (i) more than 250 workers, and (ii) more than EUR20 million in assets or net annual turnover exceeding EUR40 million, are required to draw up and present an annual non-financial information statement to the competent Mercantile Registry. The non-financial information statement must include, amongst others, the following contents:

• information on environmental issues such as pollution, circular economy and waste prevention and management, sustainable use of resources, climate change, biodiversity protection; and
• sustainability – impact of the company’s activity on employment and local development, on local populations and the territory, amongst others.

General Principles

Royal Legislative Decree 1/2015, of 24 July 2015, Royal Decree 1591/2009, of 16 October 2009 and Royal Decree 1616/2009 of 26 October 2009, contain the provisions applicable to the advertising of medical devices.

In fact, Royal Decree 1591/2009, of 16 October 2009, and Royal Decree 1616/2009, of 26 October 2009, have been repealed by the new Spanish Decree on MD, but the provisions related to advertising are still in force until the Spanish legislature comes up with a new piece of legislation to this effect.

As a general rule, any product or service which is intended for preventive, diagnostic or therapeutic purposes, as well as their advertising and commercial promotion, is subject to such legislation.

Royal Decree 1907/1996, of 2 August 1996, is also applicable to the advertising of other products with purported medical purposes.

Advertising of any product that is financed by public funds or that is in the clinical research or clinical trial phase is prohibited.

Advertising of MD shall be primarily scientific in nature and shall be targeted at, and generally distributed to, health professionals. Such advertising shall be made by persons adequately trained and possessing sufficient knowledge to provide accurate and comprehensive guidance on the advertised products, including technical data necessary to enable an objective judgement.

Medical devices intended for use or application exclusively by healthcare professionals must not be advertised to the public.

It is also expressly prohibited for all healthcare professionals and their associations or corporations to endorse any type of commercial promotion or advertising directed at the public in which they support preventive, therapeutic, rehabilitation or any other alleged health purpose.

Advertising aimed to the public must indicate the conformity of the product with the legislation in force, as well as the contraindications and possible side effects that may arise from the use of the products. Any reference to a health authority or to recommendations made by scientists, health professionals or other persons who may, by virtue of their reputation, encourage the use of the product, is prohibited.

Premiums, free gifts, discounts, prizes, contests, bonuses or similar methods in connection with the promotion or sale of medical devices to the public are also prohibited.

Cease and Desist Action in Respect of Advertising

There is a specific cease and desist action aimed at preventing or stopping illegal advertising of medical devices. This action may be brought by certain public bodies as well as by consumer and user associations and, in general, by any person with a legitimate interest.

Before bringing the action, the plaintiff must have requested the advertiser to cease the advertising activity. The advertiser can either accept the complaint and cease such activity or not accept it and risk being sued.

The cease and desist action is compatible with administrative fines arising from the relevant infringement.

Promotional Activities in Respect of Healthcare Professionals

It is prohibited to grant, offer or promise bonuses, pecuniary advantages or advantages in kind to health professionals who prescribe the products, as well as to their relatives or persons with whom they live.

Prizes, scholarships, contributions and subsidies for meetings, congresses, study trips and similar events donated by economic agents to healthcare professionals or organisations shall be applied exclusively to activities of a scientific nature.

Publications of papers and presentations at meetings, congresses and similar events shall declare the funds obtained for their realisation and the source of financing.

Prototypes

Products which are not yet in conformity with the legislation in force may be exhibited at fairs, exhibitions and demonstrations, provided that it is clearly and obviously indicated that such products are not in the market or into service until declared in conformity.

Conformity

As a general rule, all medical devices and related products that are to be put in the Spanish market must comply with MDR and have the “CE” marking.

Economic operators shall:

• submit in Spanish all the information deemed necessary for judging the conformity of a product;
• put an end to the infringement situation in the case of a product on which the “CE” marking is not affixed or is found to have been affixed improperly, or in cases of non-conformity;
• pay the costs arising from the verification of the non-conformity of a product by the health authorities, when this requires assessments or tests on the product or its technical documentation.

When the product is put in the market, the importer or distributor must ensure that the labelling and the technical instructions are in place and cover all the required information. That documentation must be in Spanish (at least).

Mandatory Registries

There are two mandatory registries under the authority of the AEMPS.

Registry of commercialisation

This is an important development of the latest Spanish regulation aimed to improve the transparency in the commercialisation of medical devices and related products.

The Registry shall contain the following information about the economic agent that commercialises products in the Spanish market: (i) identification of the economic agent, (ii) trade name of each of the products in Spain, (iii) product identifier (UDI-DI), (iv) labelling and instructions for use with which the product is to be marketed in Spain, (v) date on which the product is placed on the market in Spain, and (vi) for manufacturers reprocessing single-use devices, a declaration that the reprocessing activity is carried out within the European Union.

Registration must be previous to any commercialisation activity in Spain.

Economic agents must update their notification to the Registry annually, indicating the products they continue to market. Failure to update the notification will result in the removal of the products and the economic agent from the Registry.

Pharmacies and any other point of sale exclusively to the public are exempted from registration.

Registry of those responsible for placing custom-made products on the market

This Registry shall contain the following information about the manufacturer (or authorised representative in Spain): (i) identification of the manufacturer and address of its registered office, (ii) a list and description of the devices it manufactures, and (iii) a certificate of conformity issued by a notified body for implantable Class III devices.

These registries are entirely electronic and all communications must be made by electronic means, so a qualified electronic certificate must be in place. Also, any change to the data initially provided, as well as the cessation of marketing, shall be communicated and updated to the correspondent registry. These provisions apply to both registries.

It is important to note that these registrations are not free of charge and the applicant must pay the appropriate fees to the AEMPS. Discounts are available after a certain number of registrations, but if the volume of registrations is high, the registration process can be very costly and resource-intensive.

Distribution and Sale Activities

All distribution and sale activities must be carried out ensuring proper storage and preservation of the products.

Distributors and sellers must make a prior notification of commencement of activity to the health authority of the Spanish region (comunidad autónoma) where they are located, identifying: (i) identification of the distribution or sales establishment, where applicable, (ii) types of products it distributes or sells, and (iii) identification and qualification of the technician responsible, where applicable.

Any distribution activities shall be carried out:

• with the necessary organisation and means to take any appropriate measures in cases of potential risks related to the products and with a documented record of the products (see 2.6 Post-marketing Obligations, Including Corrective Actions and Recalls);
• under the supervision of a responsible technician properly trained and/or qualified, who shall be directly responsible for the execution of the activities and for maintaining the technical and health information on the products; and
• with the previous communication to the Registry of Commercialisation (see above).

The following sale activities are strictly forbidden:

• the sale to the public by mail order and telematic (online, by phone) procedures of medical devices subject to prescription;
• the sale to the public of implantable medical devices and any other devices intended for use or application exclusively by medical professionals or by professionals using or applying the non-medical devices listed in Annex XVI MDR; and
• street selling, in all cases.

Economic agents in the EU have an increasingly similar and harmonised regulatory framework, which helps to make internationalisation easier within the EU.

Spanish local regulation may be more complicated due to the fact that the central government has transferred almost all health competences to regions (comunidades autónomas) and to the concurrence of several official languages other than Spanish. Spanish manufacturers have similar challenges when they try to export their products within the EU.

Obviously, exportation beyond EU borders is subject to national legislation with entirely different regulatory frameworks.

In this regard, all products that are manufactured exclusively for export outside the EU and do not meet the requirements set out in MDR and/or Spanish legislation must be labelled in such a way that they are unequivocally identified as such, in order to avoid their use in the EU market.

Traceability

Any economic operator who places products on the market shall keep a documented record of the products they make available on Spanish territory, containing at least:

• commercial name of the product;
• model;
• product identifier (UDI-DI), with certain exceptions set out in MDR;
• serial number or batch number;
• date of dispatch or supply;
• identification of the economic operator who supplied the product; and
• identification of the economic operator, health institution, health professional or practitioner for devices listed in Annex XVI MDR to whom they have supplied the device.

The documentation shall be kept at the disposal of the competent authorities for a period of at least ten years after the last unit of the device has been placed on the market or put into service. In the case of implantable devices, the period shall be at least 15 years.

Market Surveillance and Corrective Actions

The AEMPS is the public body responsible for co-ordinating the market control activities to be carried out in collaboration with the health authorities of the regions (comunidades autónomas) in order to comply with MDR, including the inspection and organisation of specific control programmes.

In order to ensure the protection of human health and safety, the AEMPS may adopt all necessary and justified measures with regard to a product or category of products, such as conditions of use of such products or on special monitoring measures, and may include the necessary warnings to avoid health risks in their use.

The AEMPS and other health authorities may also conduct inspections aimed to ensure compliance with the regulatory framework. Those inspections may result in corrective and/or preventive measures, as well as sanctions (see 3.2 Regulatory Enforcement Mechanisms and 4.1 Product Safety Offences below).

Manufacturers shall inform the AEMPS of any corrective safety action before such action is taken.

Mandatory Notifications

All manufacturers, health care organisations, health care professionals and public authorities that become aware of defects, adverse effects or serious incidents related to a medical device must communicate such facts to the AEMPS. Patients and users may also communicate those facts but it is not mandatory to them.

The AEMPS will register and evaluate such information and will adopt the measures mentioned above, if any.

Spanish Agency of Medicines and Medical Devices (AEMPS)

The main regulatory authority and the competent authority for the purposes of Article 101 of the MDR under Spanish national legislation is the Spanish Agency of Medicines and Medical Products (AEMPS).

Its competences are very broad, the most relevant being the following: 

• deciding upon the definitions and classification applicable to a medical device (Annex VIII MDR);
• granting licences to manufacturers, importers, sterilisers, reprocessing entities and bundlers, and to their facilities;
• controlling the conformity of a medical device to MDR. This responsibility is carried out through the National Centre for the Certification of Medical Devices (CNCps), a public organisation under the authority of the AEMPS;
• evaluating information addressed to health professionals (technical data sheet) and to patients and consumers (package leaflet and labelling);
• evaluating the clinical safety and efficacy of the requests for variations in registered medical devices;
• controlling medical devices manufactured and used only in hospitals, including informing regional health authorities about such manufacturing and use;
• authorising the manufacturing of medical devices in medical facilities other than hospitals for urgent reasons (ie, when a public interest is at risk);
• maintaining a registry of commercialisation of medical devices;
• issuing certificates of conformity for medical device exporting purposes;
• authorising clinical trials; and
• monitoring and market surveillance over imported or manufactured medical devices and facilities (including inspection faculties).

Regional Health Authorities (Autonomous Communities)

The regional health authorities are responsible for inspecting health facilities and must co-operate with the AEMPS for the purposes of market control, registries and vigilance over the medical device.

Ministry of Health

The Spanish Ministry of Health forms an integral part of the central government and is responsible for the notified bodies and for drafting and executing regulations pertaining to the pricing and reimbursement of medicinal products (ie, medical devices) financed by public funds, among its various other duties.

Spanish regulatory authorities (AEMPS, regional authorities and Ministry of Health, each within their responsibilities and competencies) have essentially two mechanisms to enforce compliance with the applicable legislation.

• Inspection and audit powers – the authorities may inspect or audit the market agents – ie, inspect their premises, facilities, products and/or monitor their activities. These authorities may also impose preventive and/or corrective measures to ensure compliance.
• Sanctions – the authorities may initiate procedures against the market agents and impose a wide variety of sanctions such as fines, injunctions, suspension of authorisations or even revocation of such authorisations.

The AEMPS and other regional and central health authorities may impose fines on economic agents in case of non-compliance with medical device regulation.

Articles 112 and 113 of the Royal Legislative Decree 1/2015 of 24 July 2015, approving the revised text of the law on guarantees and rational use of medicines and medical devices, include the list of infractions for medical devices, cosmetic products and personal care products.

The penalties applicable to those infringements are the following:

• minor infringements – up to EUR 30,000;
• serious infringements – from EUR30,000 to EUR90,000; or
• very serious infringements – from EUR90,000 to EUR1 million, which may exceed up to five times the value of the products or services that are the object of the infringement.

The final amount depends on a wide variety of factors such as negligence and intent of the offender, fraud, collusion, failure to comply with prior warnings, turnover, number of persons affected, damage caused, profits made as a result of the infringement, permanence or transience of the risks and recidivism.

The authorities may impose other non-pecuniary penalties such as suspension (or even revocation) of the market authorisation or mandatory closure of the facilities involved.

The AEMPS has imposed important penalties in the past, such as the following:

• fined Janssen Pharma, S.L. EUR220,001, in July 2021;
• fined Valneva Sweden AB EUR132,080, in March 2022;
• fined Laboratorio Reig Jofre, S.A. EUR230,000, in July 2022; and
• fined Sanofi Aventis EUR90,001 in December 2019.

Besides the administrative penalties, the Spanish Criminal Code sets out both pecuniary penalties and imprisonment for individual persons implicated in particular serious offences. It is important to note that the Spanish Criminal Code also establishes significant non-pecuniary penalties for legal entities implicated in such offences (including, but not limited to, suspension of activities, closure of premises, disqualification for contracting with the public sector and for obtaining any public awards or subsidies).

Under Spanish law, the main legal bases on which product liability claims can be brought in respect of medical devices and the other product categories listed in 1. Applicable Product Safety Regulatory Regimes are:

• consumer and user protection legislation (mainly, Royal Legislative Decree 1/2007, of 16 November, approving the revised text of the General Law for the Defence of Consumers and Users and other complementary laws); and
• the Spanish Civil Code.

Consumer Protection Legislation

The consumer protection legislation is mandatory and every agreement, written or verbal, that goes against that legislation shall be deemed null and void.

A consumer may bring legal action against the economic agent that makes a product available in the market and also against the manufacturer on the following grounds.

Non-conformity

A product shall be deemed to be in conformity if it meets the applicable subjective and objective requirements, provided that, where applicable, the product has been properly installed or integrated. If the product is not in conformity during the first three years from the date of supply, the consumer may claim that the lack of conformity be remedied, the price be reduced or the contract be rescinded. In any of these cases, the consumer may also claim damages, if applicable.

The limitation period is five years from the date on which the non-conformity became apparent.

This legal action is not compatible with other civil actions based on non-conformity reasons (saneamiento por vicios ocultos).

Damages

As a general rule, the manufacturers shall be liable for damage caused by defects in the products which they manufacture or import. If the economic agent that makes a defective product in the market is aware of the defects, the economic agent shall be also liable for such damage.

A product is considered to be defective when it does not provide the safety conditions which may legitimately be expected.

The limitation period is three years from the date on which the consumer suffered the damage.

This legal action is compatible with other civil actions that the consumer may have for damages, including moral damages, arising from contractual liability, based on lack of conformity of the goods or services, or from non-contractual liability (if any).

Spanish Civil Code

According to the Spanish general law of obligations, a claimant may bring legal actions against a defendant when:

• there is a breach of contract (defects or other provisions) and such breach of contract causes a damage for the claimant. The limitation period is five years from the date on which the claimant suffered the damage; or
• there is non-contractual damage caused by one party to another party arising out of fault or negligent behaviour. The limitation period is one year from the date on which the claimant suffered the damage.

Lastly, the seller shall be liable to the buyer for any hidden defects or faults during the six months following the delivery of the product. The seller may claim a reduction in the price, termination of the agreement and/or claim for damages, if applicable.

Technological advancement in medical devices and consumer health products impacting the application of product liability laws

The global trend towards digital health such as telehealth or telediagnosis has been accelerating and it has the potential to improve the quality of healthcare and patient experience.

These new technologies may cause problems in terms of product liability laws. These regulations were conceived and designed in a context where medical devices were not as complex and interconnected as they are today. The complexity of medical devices makes it increasingly difficult to determine who is responsible for potential harm to patients.

A clear example would be a diagnostic application that qualifies as a medical device. It is essential that the owner or distributor of such an app clearly delineates what is the algorithm on which the diagnosis is based and what is information that the app collects from the patient or from other sources. If the boundaries are not clear, the app owner may end up being liable for damages that are not necessarily their responsibility.

There is still no clear legislation on machine learning and AI, but we should expect that the European legislature will come up with a piece of legislation that clarifies the situation and offers the best possible guarantees for patients and economic actors involved.

Civil Claims

A person that is part of a civil proceeding must be represented by a procurator and assisted by a lawyer.

The aforementioned is not mandatory in case of oral proceedings where the amount is determined by reason of the value of the claim and the amount does not exceed EUR2,000 euros and the initial application for payment order proceedings (monitorio).

As a general rule, the Spanish civil courts have jurisdiction to resolve civil claims if the defendant is domiciled in Spain. The territorial jurisdiction lies with the defendant’s domicile.

Criminal Claims

Any person may report a crime before the authorities without the assistance of a lawyer or any other professional.

If a person is part of criminal proceedings, they must be represented and assisted by a lawyer.

If a person files a criminal complaint against other person, the plaintiff (private accusation) must be represented by a procurator and assisted by a lawyer.

As a general rule, the Spanish criminal courts have jurisdiction to resolve criminal claims if the crime has been committed in Spain. The territorial jurisdiction lies with the place where the crime was committed.

The main judicial costs that the parties may have to consider when filing legal proceedings in Spain are as follows.

• Judicial fees – this only applies to certain legal entities (not individual persons). There are exemption rules that may apply. The fee has a fixed part (depending on the nature of the legal proceedings and up to EUR1,200) and a variable part (depending on the amount of the legal proceedings and up to EUR10,000). This judicial fee may be partially recovered if the legal proceeding ends before a trial (full settlement or a settlement agreement is reached that ends the dispute).
• Legal fees – these are the fees of the professionals involved in the proceedings (lawyer and procurator).

As a general rule, Spanish courts abide by the “loser pays” principle. That means that the losing party may be liable for the winning party’s judicial and legal fees, as well as any disbursements for witnesses and expert evidence.

There is no mechanism to displace the costs rules by way of “without prejudice” settlement offers or lodgements.

As a general principle, all administrative resolutions or decisions (including sanctions) issued by Spanish administrative bodies may be challenged before a judge or court.

Spanish civil procedural law allows popular or collective action when a group of consumers is affected by a harmful event and where the individuals making up the group are identified or easily identifiable.

There are also certain associations or bodies duly authorised according to EU law to bring an action for injunctions for the protection of the collective and diffuse interests of consumers and users.

At the date of writing in July 2023, the authors are not aware of any significant examples of these kinds of proceedings regarding medical devices in Spain.

The following alternative dispute resolution (ADR) mechanisms are available in Spain:

• amicable settlement;
• arbitration; and
• mediation or conciliation.

Self-regulatory mechanisms also exist for medical devices and drugs advertising. These mechanisms operate through associations of economic operators who submit to arbitration disputes over the advertising of their products, which is much quicker and more effective than through the court process. The resolutions adopted by arbitrators are not legally binding (an economic operator may bring the matter to the judicial system) but create a precedent that is often considered by judges and tribunals. Not abiding by these extra-judicial resolutions may also have reputational consequences for the economic operator.

In general, the same facts may constitute an administrative infraction and serve, at the same time, as grounds for a product liability claim (civil and/or criminal).

The administrative bodies cannot impose a double sanction for the same facts and based on the same protected public interests. Those administrative bodies must report any potential criminal conduct found during an administrative proceeding to the public prosecutors.

If there is an ongoing criminal cause, the administrative proceedings based on the same facts shall be suspended until there is a firm judicial decision.

In April 2022, the new Law 7/2022 of 8 April on waste and contaminated land for a circular economy came into force. This law, in line with European environmental developments, aims to promote the transition to a circular economy, in which waste generation is reduced and available resources are used more efficiently.

Law 7/2022 transposes Directive 2008/98, which establishes the framework regulation for waste management, as well as Directive 2019/904, which focuses on tackling the problem of single-use plastics. One of the most outstanding and innovative measures of this new law is the creation, with effect from 1 January 2023, of the special tax on non-reusable plastic packaging.

This tax is levied on the use in Spanish territory of non-reusable packaging containing plastic.

However, there are certain sectors that will benefit from exemptions and refunds of the tax.

One of these sectors is the pharmaceutical sector, in which non-recyclable plastics intended for packaging for medicines, MD, foodstuffs for special medical purposes or hazardous waste of medical origin will be exempt from the tax.

In order for this exemption to be applicable, companies marketing these products must provide a prior declaration to the producers or importers of packaging, specifying the destination of such packaging.

The exemption for medicinal products also extends to active substances used in the manufacture of pharmaceutical products.

The EU Commission adopted a proposal for a new Directive and a new Regulation, in April 2023.

Such proposal revises and replaces the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicines for children and for rare diseases (Regulation 1901/2006 and Regulation 141/2000/EC, respectively).

The proposal, in addition to strengthening the requirement for common standards of quality, safety and efficacy – the backbone of the medicines system – aims to achieve the following:

• promoting innovation and access to affordable medicines, creating a balanced pharmaceutical ecosystem;
• introducing variations in data exclusivity periods during the regulatory approval process for medicines, extending these exclusivity periods in cases of innovation in areas of unmet medical need;
• increasing competition with earlier market access for generic and biosimilar medicines;
• increasing transparency on the contribution of public funds to research and development costs;
• reducing the environmental impact of medicines;
• reducing the regulatory burden and establishing a flexible regulatory framework to favour innovation and competition;
• establishing specific measures relating to the quality and manufacture of medicines with very short shelf lives or highly personalised medicines; and
• anticipating notifications in case of supply difficulties to increase security of supply.

In Spain, it is quite possible that the announced reform of the Royal Legislative Decree 1/2015 of 24 July 2015, approving the revised text of the Law on guarantees and rational use of medicines and health products, will be affected by the revision of European legislation, and it is to be expected that such reform will be undertaken when there is a new European framework for medicines.

Competences over drug pricing and reimbursement policies are exclusive to each member state of the European Union, and it will therefore be necessary to wait for the reform of Spanish pharmaceutical legislation to ascertain the scope of the review of the pricing system, which is demanded by all the agents involved.

Spanish regulation on promotion of medicines (currently governed by RD 1416/1994) and on medical devices is also in the course of being amended.

The advent of AI will undoubtedly impact the development of medicines and medical devices.

In a highly regulated sector, the European legislation in this area announced by the European Commission, will be welcomed, as a balance between innovation and safety must be sought.

It is worth noting the high potential of AI in data and pattern analysis, which will accelerate the development and invention of new products.

There is currently no specific regulation for AI in Spain, although Law 15/2022, of 12 July 2022, on equal treatment and non-discrimination, introduces a reference when obligating public administrators to minimise biases and ensure transparency and accountability in the use of automated decision-making mechanisms.

The Ministry of Economic Affairs and Digital Transformation has designed, within the Recovery, Transformation and Resilience Plan, a National Artificial Intelligence Strategy to structure the action of the different administrations and to provide a framework of reference for the public and private sectors.

Spain Digital Strategy 2026

This plan is aimed at implementing certain measures and actions in the field of AI and the Data Economy:

• creation of the Data Office and the figure of the Chief Data Officer;
• implementation of the Artificial Intelligence Advisory Council;
• publication of the Charter of Digital Rights;
• approval of the National Plan for Language Technologies;
• PERTE: New Language Economy;
• Quantum Spain initiative, a strategic supercomputing project;
• GAIA-X, Spanish hub for the national development of sectoral data space and data management;
• National Green Algorithms Programme (PNAV);
• regulatory sandbox for the implementation of the future European AI Regulation;
• creation of the National Centre for Neurotechnologies; and
• creation of the National Agency for Artificial Intelligence Oversight.

Spain Charter of Digital Rights

As is covered in the Trends and Developments section of this guide, in 2021, the Spanish government published the Charter of Digital Rights, which is actually a non-regulatory and non-binding government document that serves as a statement of intentions of the authorities in relation to AI.

This document establishes in its Title XXV a list of rights in relation to AI, which may reflect the basis (albeit non-binding) for future legislation.

• AI shall guarantee the person-centered approach and his or her inalienable dignity, pursue the common good, and ensure compliance with the principle of nonmaleficence.
• In the development and life cycle of artificial intelligence systems:
1. the right to non-discrimination shall be guaranteed, regardless of the origin, cause or nature thereof;
2. the right to non-discrimination shall be guaranteed, regardless of its origin, cause or nature, with respect to decisions, use of data and processes based on artificial intelligence;
3. conditions of transparency, auditability, accountability, traceability, human oversight and governance shall be established. In any case, the information provided shall be accessible and understandable; and
4. accessibility, usability and reliability shall be guaranteed.
• Individuals have the right to request human oversight and intervention and to challenge automated decisions made by artificial intelligence systems that impact their personal and property sphere.

What’s Coming: European Union AI Regulation

On 14 June 2023, the European Parliament approved its version of the draft EU Artificial Intelligence Law (the “EU AI Law”, also called the “AI Act”).

Now Member States will need to reach agreement on the final text, so final and approved adoption of the EU AI Law is not expected until well into 2025, at the earliest.

The approval of this text could have a direct impact on the regulation of medical devices based on AI, given that the draft itself establishes that AI-based medical devices may be considered high-risk products.

It states in this respect that AI systems that are safety components of products or that are products themselves falling within the scope of certain EU harmonisation legislation should be classified as high risk if the product in question is subject to the conformity assessment procedure with a third party conformity assessment body under such relevant Union harmonisation legislation. Such products are, among many others of different nature, medical devices and in vitro diagnostic medical devices.