Medical Devices

The safety regulatory regime for medical devices is contained in the EU Medical Devices Regulation (EU) 2017/745 (MDR), together with the German Medical Device Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz – MPDG) and several ancillary regulations.

The regime also governs software-based devices that are intended by the manufacturer to provide diagnostic or therapeutic services.

Reusable surgical instruments have now also been included in the MDR in their own category, referred to as “I R”.

Personal Protective Equipment (PPE)

PPE is governed by Regulation (EU) 2016/425 (the “PPE Regulation”).

Cosmetics

The product safety regulatory regime for cosmetics is contained in the Cosmetics Regulation (EC) 1223/2009, supplemented by the German Cosmetics Regulations and various specific regulations concerning, for example, hazardous substances and packaging.

Biocides

The European Biocidal Products Regulation (EU) 528/2012 (BPR) contains the safety regime for biocides. Several Technical Notes for Guidance provide further technical detail for the implementation of the BPR. On a national level, the BPR is flanked by the Biozidrechts-Durchführungsverordnung (ChemBiozidDV).

Food

Food-based healthcare products need to comply with requirements laid down in Regulation (EC) No 852/2004, the Food Act (Lebensmittelgesetz) and any additional relevant applicable regulations, such as the Dietary Supplements Regulations (Nahrungsergänzungsmittelverordnung – NemV), which transpose European Directive 2002/46/EC on food supplements, and the Diätverordnung (Dietary Regulations – DiätV).

The German Food Code Commission (Deutsche Lebensmittelbuch-Kommission) issues general guidelines based on international standards on the production of food.

According to a statement published by the federal government, no genetically modified organisms (GMOs) have been grown commercially in Germany since 2012. Where GMOs enter the market, the relevant European framework applies, including:

• Regulation (EC) 1829/2003 on genetically modified food and feed;
• Regulation (EC) 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms; and
• Regulation (EC) 1946/2003 on transboundary movements of GMOs.

Pharmaceuticals

Pharmaceuticals for human use are governed by the German Drug Act (Arzneimittelgesetz – AMG), which implements European Directive 2001/83/EC. Alongside the AMG, regulations such as the Medicinal Products and Active Ingredients Manufacturing Regulations (Arzneimittel- und Wirkstoffherstellungsverordnung – AMWHV) govern the manufacture and distribution of pharmaceuticals, as well as their use in clinical trials.

Blood Products

Blood products are subject to the framework laid down in the Transfusion Act (Transfusionsgesetz – TFG). The TFG follows the principle contained in many pieces of legislation in the areas touched upon in this chapter that statutory provisions contain the necessary minimum and are to be supplemented by more detailed technical guidance compiled by experts. The Haemotherapy Directive of 2017 (as amended), published by the German Medical Association together with the Paul-Ehrlich-Institute (PEI), provides that detail.

Psychedelics

Psychedelics are classed as narcotics pursuant to Section 1 of the Narcotics Act (Betäubungsmittelgesetz – BtMG). This means that a permit to traffic these substances can only be granted by the Federal Institute for Drugs and Medical Devices (BfArM), or more precisely the Federal Opium Agency, in exceptional cases for scientific or other purposes in the public interest. Such purposes might include clinical trials where the requirements of the AMG will apply simultaneously. 

Cannabidiol

All food supplements that contain CBD or other cannabinoids are considered novel food pursuant to Regulation (EU) 2015/2283 and thus are only marketable after prior authorisation. Their THC content must stay below 0.2%, or they will be classed as pharmaceuticals and be subject to the regulatory regime of the AMG (see 1.1 Medical Devices).

Medical Apps and Wearables

An app will be regulated as a medical device if it meets the MDR’s definition of a medical device, which it will normally do if it creates or modifies medical information through its own algorithm. As a medical device, it will be subject to the MDR and the MPDG (see 1.1 Medical Devices).

Where wearables are developed for medicinal use, such as for diagnosis and therapy purposes, they will also be subject to the MDR and MPDG regime. Common wearables such as Fitbits, however, are not classed as medical devices and are only subject to the Product Safety Act (Produktsicherheitsgesetz – ProdSiG) and related legislation.

Telemedicine

Doctors may provide telemedicine services where face-to-face patient contact is not medically required. The framework for telemedicine is contained in the Social Code. This is flanked by a collective agreement between GKV-Spitzenverband and the German Medical Association, which sets out the requirements regarding patient authentication and data privacy, and quality requirements for telemedicine service providers in the public healthcare system.

Stem cells

The German Stem Cell Act (Stammzellengesetz – StZG) generally prohibits the import and use of embryonic stem cells, but exceptionally permits their import and use for research purposes. Section 6 of the StZG sets out the requirements for authorisation.

Distinction Between Medicines and Medical Devices

According to Section 2 (1) of the AMG, medicines are substances or preparations of substances that are intended to alleviate, cure or prevent diseases or pathological complaints (“presentational pharmaceuticals”), or that are intended to restore, correct or influence physiological functions using a pharmacological, immunological or metabolic effect, or to make a medical diagnosis (“functional pharmaceuticals”).

Medical devices, on the other hand, are products or equipment that are intended for a medical purpose. Unlike medicines, which have a pharmacological, immunological or metabolic effect, the main intended effect of medical devices is primarily achieved by physical means.

Under the EU regime, it is for the national competent authorities and national courts to assess products as medicines, medical devices, cosmetics or food, as appropriate, on a case-by-case basis. To assist with the classification of products, the European Medical Device Co-ordination Group (established by Article 103 of Regulation (EU) 2017/745) produced the non-binding “MDCG 2022 – 5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices” in April 2022, which provides detailed guidance.

Distinction Between PPE and Medical Devices

When it comes to the distinction between PPE and medical devices, the intended purpose is key. If the product is intended solely to protect the user (ie, the person wearing it) against one or more risks to their health or safety, the product is classified as PPE. Where the product is intended to protect a patient, the product is a medical device.

For instance, surgical gloves are medical devices, while protective gloves (eg, as used in medical laboratories) are PPE. Protective clothing against radiation for patients are medical devices; for users, they are PPE.

Distinction Between Cosmetics, Biocides and Medicines

The European Commission gave some guidance on the differentiation between cosmetics and biocides when various manufacturers sought to produce hand sanitisers in the wake of the COVID-19 pandemic. In summary, products that serve primarily or exclusively cosmetic purposes (ie, for deep cleansing or cleansing of the skin) are covered by the Cosmetic Products Regulation. Products that contain an “active substance” and are primarily intended to serve as a biocide fall within the scope of the legislation on biocides. The Biocide Regulation defines an active substance as a substance or micro-organism that has an effect on or against harmful organisms.

When differentiating between biocides and medicines, the key criterion is what the product is used against: medicines are intended to combat diseases, whereas biocides are directed against harmful organisms that transmit disease.

Distinction Between Medicines and Food

The Federal Office of Consumer Protection and Food Safety (BVL) and the Federal Institute for Drugs and Medical Devices (BfArM) have jointly prepared a position paper, to serve as guidance for the differentiation between food and pharmaceuticals. It sets out seven characteristic features, and provides a decision tree at the end. The criteria include patient population, nutritional value and/or substances used, and whether the same effect can be achieved through changes in diet.

Medical Devices

Manufacturing facilities for medical devices do not require approval as such. However, the conformity assessment procedures may involve a notified body assessment of the manufacturer’s quality system. The manufacturer demonstrates conformity with the requirements of the quality system by complying with the applicable standards, including ISO 13485:2016 on Standards for Quality Management System on Medical Devices.

Pharmaceuticals

Manufacturers of medicinal products, on the other hand, must obtain a manufacturing authorisation. The authorisation will be limited to the premises and the medicinal products specified in the manufacturer’s application.

Furthermore, medicinal products must be manufactured in accordance with the principles of Good Manufacturing Practice, as set out in the AMWHV.

Manufacturers must appoint at least one “qualified person” to be ultimately responsible for certifying that each batch of finished product released onto the market has been manufactured in accordance with Good Manufacturing Practice and the specifications set out in the marketing authorisation.

Blood Products

A licence pursuant to section 13 of the AMG is required for the production of blood and blood products. Furthermore, the Transfusion Act sets out staffing requirements for blood donation facilities, among other matters.

Cosmetics

Manufacturers must comply with good manufacturing practice. Compliance is presumed where the manufacturing is in accordance with the relevant harmonised standards – see Article 8 of the Cosmetics Regulation.

Pursuant to Article 4 of the Cosmetics Regulation, manufacturers must designate a “responsible person” within the EU who shall ensure compliance with the obligations set out in the Regulation for each cosmetic product.

Biocides

Manufacturing authorisation is not required but product authorisation is; please see 2.4 Marketing and Sales.

Personal Protective Equipment

Manufacturers must ensure that PPE has been designed and manufactured in accordance with the essential health and safety requirements set out in Annex II, where applicable (Article 8(1) of the PPE Regulation).

Food

All businesses that produce, process or distribute food must be registered, and each site must be registered.

Those who produce, manufacture or handle food of animal origin also require approval.

Regulation (EC) 852/2004 requires all food business operators to develop, implement and maintain food safety management systems based on the hazard analysis and critical control point (HACCP) principles.

There are no specific obligations relating to corporate social responsibility, the environment or sustainability that would affect only medical products or consumer health products. However, general legislation does also impact those products over their life cycle – for instance, the Packaging Act (Verpackungsgesetz) transposes the European Packaging and Packaging Waste Directive.

General Rules on Advertising

Regardless of the type of product, misleading advertising is in breach of anti-competition law. Pursuant to Section 5 of the Act Against Unfair Competition (Gesetz gegen den unlauteren Wettbewerb – UWG), misleading advertising includes all actions that may cause market participants to make a decision that they would not have made otherwise.

Misleading actions include:

• untrue statements;
• statements that are designed in such a way that they can be misunderstood; and
• advertising with self-evident facts (eg, advertisement with no features that are required by law).

Medical Devices

For medical devices, Article 7 of the MDR contains its own restrictions on advertising, prohibiting the use of text, names, pictures and signs that may mislead with regard to the device’s intended purpose, safety and performance by:

• ascribing functions and properties to the device which the device does not have;
• creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
• failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; or
• suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

The German Drug Advertising Act (Heilmittelwerbegesetz – HWG) also applies to medicines and, according to Section 1 (1) No 1a), to medical devices as defined by the MDR. It contains further restrictions and distinguishes between the lay and the professional audience.

Section 11 of the HWG contains a list of prohibitions concerning advertising to lay people. For example, it is not permitted to suggest that health would deteriorate if a certain product is not used. The use of testimonials that could mislead is also prohibited, as is the use of health stories.

Professional circles are exempt from the negative list in Section 11 of the HWG. Where the target group is “medical professionals”, the requirement of truthfulness of information applies, meaning statements need to be backed by scientific evidence.

Pharmaceuticals

In relation to pharmaceuticals, Section 12 of the HWG contains a further negative list concerning adverts aimed at lay audiences. It prohibits all advertising in relation to notifiable diseases, cancer, addictions (with the exception of nicotine addiction) and complications in pregnancy.

Biocides

Pursuant to Article 72 of the BPR, any advertisement for biocidal products shall include the sentences “Use biocides safely. Always read the label and product information before use.”

Cosmetics

Regulation (EU) No 655/2013 established common criteria for substantiating advertising claims related to cosmetic products. Advertising claims must be true, substantiated, fair and honest, as well as clear and understandable, and must enable informed decision-making by the target group. Advertising with legal compliance is not permitted. The standard of assessment is the perception of the average end consumer.

The European Commission has published “Guidelines to Commission Regulation (EU) No 655/2013 laying down common criteria for the justification for claims used in relation to cosmetic products” for further guidance.

Medical Devices

Medical devices may only be placed on the market or put into service if they bear the CE marking, which may only be affixed if the medical device meets the Essential General Safety and Performance Requirements and the relevant conformity assessment procedure has been carried out. The Essential General Safety and Performance Requirements are defined in Annex I of the MDR.

Which conformity assessment procedure is to be carried out and to what extent an independent testing and certification body (notified body) is to be involved depend on the potential risk posed by devices. For this purpose, the MDR categorises devices into four classes (I, IIa, IIb, III):

• Class I: all non-invasive devices, unless another class refers to such devices;
• Class IIa: all non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction;
• Class IIb: all non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body; and
• Class III: generally all invasive devices.

Products in Class I must pass the conformity assessment procedures at the manufacturer’s own risk. The manufacturer must prepare documentation, including risk assessment documentation, to be submitted to the authorities if requested. Devices in Classes IIa, IIb and III are subject to more rigorous procedures before a CE mark can be placed on the product. For medical devices in these classes, notified bodies participate in the verification procedures and provide certificates. Manufacturers can contact a European Notified Body of their choice, which is designated for the relevant procedure and the relevant product category. The German notified body is the Technical Inspection Association (TUV).

Medical apps and wearables

Medical apps and wearables that qualify as medical devices follow the same regime. However, the documents that manufacturers have to prepare to demonstrate the conformity of their app with the basic requirements of the MDR differ. They include the following in particular:

• a risk management file compliant with the requirements of ISO 14971;
• a usability file conforming to the requirements of IEC 62366; and
• a software file conforming to the requirements of IEC 62304.

Pharmaceuticals

Although there are some exemptions (eg, for pharmacies and hospitals), a manufacturing licence from the competent local authority is required for the commercial manufacturing of pharmaceuticals (Section 13 of the AMG).

Applicants must comply with Good Manufacturing Practices, which are set out in the relevant regulations relating to the production, preparation, processing, transfilling, pre-packaging, marking and release of medicines.

A finished medicinal product can only be placed on the market after a marketing authorisation has been granted by the German Higher Federal Authority or the European Commission (Section 21 of the AMG).

Personal Protective Equipment

Under the PPE Regulation regime, manufacturers must:

• ensure PPE has been designed and manufactured in accordance with the necessary health and safety requirements;
• draw up technical documentation providing the following:
1. a complete description of the PPE and its intended uses;
2. disclosure of the risks against which the PPE will protect;
3. a list of the essential health and safety requirements that are applicable to the PPE; and
4. design blueprints and schemes of the PPE and its components;
• keep technical documentation and the EU declaration of conformity for ten years after the PPE has been placed on the market;
• ensure procedures are in place for production to remain in conformity with this Regulation – any alterations to the manufacturing of the PPE must be recorded;
• ensure that PPE placed on the market bears distinct identification or, where not possible, that the required information is provided on the packaging or supporting PPE documents;
• indicate their name or affiliation on the documentation or PPE, and an address where they can be contacted;
• ensure that PPE is accompanied by instructions and information, which must be clear, understandable, intelligible and legible;
• provide the EU declaration of conformity with the PPE in some shape or form;
• take necessary measures to bring PPE into conformity if they believe that PPE that is not compliant has been placed on the market; and
• be able to provide all the information and documentation necessary to demonstrate the conformity of their PPE with this Regulation.

Cosmetics

Before a cosmetic product can be released on the market, proof must be provided that it is safe for human health during the course of its intended use or what are considered to be reasonably foreseeable conditions of its use. A safety assessment must be performed and a cosmetic product safety report provided to demonstrate compliance with Article 3 of Cosmetics Regulation (EC) 1223/2009, which in turn imports safety requirements from Directive 87/357/EEC.

Certain ingredients are prohibited under Chapter IV of Cosmetics Regulation (EC) 1223/2009, based on their threat to human health. The Annexes contain lists of chemical substances that are either banned or restricted for use in specific product types or to certain limits in the final product.

Further requirements imposed by the Regulation include:

• a notification requirement if the manufacturer becomes aware that the cosmetic product presents a threat to human health (the notification is to include details of the risks of using the product, non-compliance issues and what corrective actions will be performed);
• a requirement to maintain an accessible product information file for at least ten years after the last batch of the product was placed on the market;
• oversight of sampling and analysis of cosmetic products; and
• comprehensive labelling requirements.

Biocides

The BPR regime imposes two anchor requirements before biocidal products can be made available on the market and used:

• active substances in biocidal products must be approved at EU level for use in that type of product, or the active substances the product contains must be included in the Review Programme for that product type; and
• biocidal products must be authorised before they can be placed on the market, either at a member state level by the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA), or at EU level.

A simplified authorisation procedure is available where a biocidal product complies with all of the following conditions, which are set out in Article 25 of the BPR:

• all the active substances contained in the biocidal product must appear in Annex I of the BPR and comply with the specified restrictions;
• the biocidal product must not contain any substance of concern as defined in Article 3 of the BPR;
• the biocidal product must not contain any nanomaterials;
• the biocidal product must be sufficiently effective; and
• the handling of the biocidal product and its intended use must not require PPE.

The applicant seeking authorisation must submit an application to the European Chemicals Agency (ECHA) indicating which member state competent authority will evaluate the application (Article 26 of the BPR).

Authorisation holders must keep records of the biocidal products they place on the market for at least ten years after placing on the market, or ten years after the date on which the authorisation was cancelled or expired, whichever is the earlier.

Food

The German Federal Office of Consumer Protection and Food Safety must be notified the first time a food product is placed on the market (Section 5 of the NemV), and of the placing on the market of foods for specific groups (food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control – Section 4a of the DiätV).

Certain food products require a manufacturing authorisation (such as food for special medical purposes). The following requirements must be met for authorisation to be granted for food products for special medical purposes (Sections 11 and 14 of the DiätV):

• the person responsible for the manufacturing must have sufficient experience and be sufficiently reliable;
• the manufacturer must have sufficient equipment to ensure proper manufacturing, particularly correct dosing and mixing;
• manufacturing must be based on medical and dietetic principles; and
• results must be safe and effective (in particular, the nutritional needs of patients must be met).

Additional requirements vary according to the type of food product for special medical purposes.

Generally, only specific additives can be used when manufacturing a food product (Section 5 of the DiätV).

Dietary supplements can only be manufactured if they comply with Section 3 of the NemV. These can only be manufactured using nutrients listed in Annex I to the Food Supplements Directive in the forms listed in Annex II of the same Directive. In addition, the purity criteria set out in Regulation (EU) 231/2012 apply.

German manufacturers of medical devices and health products have an advantage, alongside their other European competitors, in that the regulatory environment is largely aligned within the EU, and the framework is not too dissimilar in some other states (eg, Australia).

Germany as a market, while consumer-friendly, does not entertain mass tort claims as seen in the USA, for example, and damages are fairly low.

While German manufacturers will explore other markets, Germany is a popular target market for non-German manufacturers.

Medical Devices

The regime for post-marketing obligations, including corrective actions and recalls, is set out in Chapter VII of the MDR and can be summarised briefly as follows.

• The manufacturer’s quality management system must address the process for the reporting of serious incidents and field safety corrective actions in the context of vigilance and management of corrective and preventative actions and verification of their effectiveness (Article 10(9) of the MDR).
• For each device, the manufacturer must plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate to the type of the device. That system must be an integral part of the manufacturer’s quality management system (Article 83(1) of the MDR).
• The post-market surveillance system must be based on a post-market surveillance plan, the requirements of which are set out in Section 1.1 of Annex III of the MDR.
• Manufacturers must prepare surveillance reports, namely Post-Market Surveillance Reports for Class I medical devices and Periodic Safety Update Reports for Class IIa, IIb and III devices. Both types of report must summarise the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan, together with a rationale and description of any preventative and corrective actions taken.
• Manufacturers must report serious incidents and field safety corrective actions.
• Reports of serious incidents must be made immediately after the manufacturer has established the causal relationship between the incident and their device or that such causal relationship is reasonably possible, and no later than 15 days after they become aware of the incident. In the event of death or an unanticipated serious deterioration in a person’s state of health, the report shall be provided immediately after the manufacturer has established – or as soon as it suspects – a causal relationship between the device and the serious incident but no later than ten days after the date on which the manufacturer becomes aware of the serious incident. In the event of a serious public health threat, the report shall be provided immediately, and no later than two days after the manufacturer becomes aware of that threat.
• Field safety corrective actions must be reported in advance of being taken, except in cases of urgency where the manufacturer has to take action immediately.

Pharmaceuticals

The post-market obligations relating to pharmaceuticals are not dissimilar to the above, although some details differ.

Marketing authorisation holders and pharmaceutical companies are to:

• appoint a qualified person who is resident in a member state of the European Union and has the required expert knowledge and reliability necessary to exercise their function (graduated plan officer) to set up and manage a pharmacovigilance system and to collect and evaluate notifications on medicinal product risks that have become known and co-ordinate the necessary measures;
• scientifically evaluate all of the information, examine risk minimisation and prevention measures and, if necessary, take risk minimisation and prevention measures immediately based on their pharmacovigilance system;
• audit their pharmacovigilance systems regularly at appropriate intervals;
• maintain a pharmacovigilance master file and make this file available on request;
• record every suspected serious adverse reaction in Germany of which they gain knowledge, and electronically inform the competent higher federal authority immediately, or at the latest within 15 days of acquiring this knowledge;

• record every suspected serious adverse reaction in a third country of which they gain knowledge, and electronically inform the competent higher federal authority and the European Medicines Agency immediately, or at the latest within 15 days of acquiring this knowledge; and
• submit regularly updated reports on the safety of medicinal products (Periodic Safety Update Reports) as set out in Section 63d of the AMG and in Directive 2010/84/EU.

Biocides

Specific requirements for biocides include:

• record-keeping for at least ten years after placing on the market, or ten years after the date on which the authorisation was cancelled or expired, whichever is the earlier; and
• preparing and making available safety data sheets for active substances and biocidal products, in accordance with Article 31 of Regulation (EC) No 1907/2006, where applicable.

Cosmetics

Under Regulation (EC) No 1223/2009, notification is required of serious undesirable effects without delay to the competent authority where the serious undesirable effect occurred, including all serious undesirable effects that are known or that may reasonably be expected to be known, the name of the cosmetic product concerned, enabling its specific identification, and the corrective measures taken, if any.

Other Products

The Product Safety Act obliges manufacturers, importers and also distributors to place only safe products on the market. In addition, manufacturers must conduct active market surveillance. This means that, depending on the hazardousness of the product, spot checks must be carried out, complaints must be investigated and dealers must be informed.

Manufacturers must also take precautions that will lead to a rapid and reliable elimination of the hazard in the event of a recall becoming necessary. This means that the manufacturer must operate a risk management system and make a prior organisation for the recall case.

The competent authorities must be informed as soon as it is known or there are clear indications that a product on the market poses a risk to health and safety.

Regulatory oversight over pharmaceuticals and medical devices is divided between federal authorities and state level authorities.

Medical Devices

The federal BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) is responsible for the following, among other things:

•       authorising clinical investigations of medical devices;

•       deciding on the classification of individual medical devices and their differentiation from other products, on request;

•       evaluating incident reports on risks relating to products already on the market; and

•       assessing notifications of serious incidents and corrective actions.

The state (Lander) level authorities are responsible for general oversight, inspections and enforcement (see Section 85 of the MPDG).

Notified bodies assess whether medical devices comply with the standards for CE marking and issue certifications.

Pharmaceuticals

The federal BfArM and the PEI are primarily responsible for issuing national marketing authorisations, for approving clinical trials, and for pharmacovigilance. The PEI assumes these responsibilities for biological pharmaceuticals and advanced therapy medical products, while the BfArM assumes them for all other pharmaceuticals (centralised authorisations are issued by the European Commission based on the evaluation of the European Medicines Agency).

The state (Lander) level authorities are responsible for issuing manufacturing, wholesale distribution and import licences, and for oversight, inspections and enforcement.

The BfArM and the PEI are themselves subject to oversight by the Federal Ministry of Health, which has the authority to issue directives.

Blood Products

The PEI is competent for regulating blood products. The state (Lander) authorities supervise the collection, processing, storage and testing of blood and blood products.

Food

Generally, the states (Lander) are responsible for monitoring food products. However, there are some notable exceptions relating to notification requirements to federal authorities – see 2.1 Design and Manufacture.

The individual state (Lander) authorities are also responsible for authorising the manufacturing of specific products, such as iodised table salt substitute, dietetic food with added iodine compounds or food for special medical purposes (Section 11 (1) of the DiätV).

Biocides

Authorisation of biocide products is a matter for the Federal Chemicals Agency (Bundesstelle für Chemikalien) at the BAuA.

The individual state (Lander) authorities are responsible for monitoring and market surveillance.

Other Products

The market surveillance authorities responsible for products covered by the Product Safety Act are the administrative districts or trade supervisory offices.

Medical Devices

BfArM has extensive powers (see Section 85(2) of the MPDG), ranging from making decisions on product classification where the notified body and the manufacturer cannot agree on the proper classification, through to stopping production and instigating recalls and seizures of products.

Pharmaceuticals and Blood Products

Under Section 69 of the AMG, the authorities have wide-ranging powers.

They issue the necessary directives to rectify any offences that have been identified and to prevent offences in the future. They may also prohibit the marketing of medicinal products or active substances and order their recall from the market and seize them in the following circumstances:

• if the required marketing authorisation or registration of the product has not been submitted or if its suspension has been ordered;
• if the product or the active substance has not been manufactured according to recognised rules or does not possess the appropriate quality in keeping with recognised rules;
• if the product is lacking in therapeutic efficacy;
• if there is sufficient reason to suspect that the product has harmful effects that exceed the bounds considered justifiable according to the prevailing standard of scientific knowledge;
• if the prescribed quality controls have not been carried out; or
• if the authorisation required for the manufacturing has not been granted.

Biocides

The Federal Chemicals Agency will inform the relevant Lander authority if an authorisation of a product has expired (Section 8 of the ChemBiozidDV); said authority will carry out any required surveillance functions (see also Other Products, below, for surveillance functions).

Food

The competent authorities are tasked with verifying food businesses’ compliance with these due diligence obligations through regular, risk-based controls and sampling. To that end, establishments are classified into risk categories upon registration. In addition to the risk-based inspections, there are also ad hoc inspections to investigate acute issues. If violations are detected, the competent authorities take the necessary measures to remedy the situation, which may include recalls and product seizures.

Other Products

Pursuant to Section 9 of the ProdSiG and the provision of the Market Surveillance Act (Marktüberwachungsgesetz – MüG), the relevant authorities are authorised to monitor by taking and assessing samples, and to take the necessary measures if they have reasonable grounds to suspect that a product does not comply with safety requirements.

For instance, they can:

• order measures to ensure that a product is not placed on the market until it complies with the requirements;
• order that a product be inspected by an approved body or by a similarly qualified body;
• order that suitable, clear and easily understandable warnings are affixed about hazards emanating from the product;
• temporarily prohibit the placing on the market;
• order the withdrawal or recall of a product, seize such a product and, if a risk to the user or third party cannot be eliminated by other means, arrange for its safe disposal; and
• warn the public if other equally effective measures (eg, warnings by the manufacturer) are not issued or are not issued in good time.

Violations of the ProdSiG can lead to fines or imprisonment for the individuals responsible. Fines of up to EUR100,000 may be imposed on manufacturers and others (eg, importers) for certain offences, pursuant to Section 28 of the ProdSiG. Under Section 29, repeated and persistent violations of individual, specific obligations may result in a prison sentence of up to one year.

The AMG and MPDG provide for fines or sentences of up to three years – eg, for placing unsafe medicinal products or medical devices onto the market (Sections 95 and 96 of the AMG and Sections 92 and 93 of the MPDG).

Section 17 of the ChemBiozidDV renders certain breaches administrative offences, and makes any intentional acts that endanger the life or health of another or property of significant value criminal offences.

Real-life examples of the application of such penalties are rare and tend to involve counterfeit products rather than other safety-relevant breaches.

Claims in relation to defective products may be brought under the following:

• the Product Liability Act (Produkthaftungsgesetz), which implements the European Product Liability Directive (85/374/EEC) and provides for a strict liability regime;
• Section 84 of the AMG in relation to death or injury as a result of the administration of a medicinal product – liability under the AMG is strict; and
• Sections 823 et seq of the Civil Code (Bürgerliches Gesetzbuch), which provide for a fault-based liability system under tort law.

The local civil courts (Amtsgerichte) will hear claims with value up to EUR5,000, and regional civil courts (Landgerichte) will hear higher-value matters, provided they have local jurisdiction pursuant to Regulation (EU) 1215/012 and the provisions of the Civil Procedure Rules (ZPO).

For cross-border cases, this means that proceedings may be brought in the courts for the place where the following applies:

• The defendant is domiciled there.
• The harmful event occurred or may occur. This can be either the place where the damage occurred (this will often be where the claimant is based), or the place of the event giving rise to it. In product liability claims, the place of the event giving rise to the damage is the place where the defective product was manufactured (Kainz v Pantherwerke AG (Case C-45/13) EU:C:2014:7).
• A co-defendant is domiciled there, provided the claims are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments (see Article 8(1) of Regulation (EU) 1215/012).

For domestic cases, the court with local jurisdiction will also normally be the court either where the defendant is based or where the harmful event occurred.

For declaratory model proceedings (see 4.6 Class Actions, Representative Actions or Co-ordinated Proceedings), the only court with jurisdiction is the higher regional court (Oberlandesgericht) where the defendant is domiciled, if that domicile is in Germany (Section 32c of the ZPO).

As German costs rules abide by the loser pays principle, the losing party is liable for the court fees, the other party’s statutory legal fees and any disbursements for witnesses and expert evidence.

Parties may retain their lawyers on the basis of hourly rates. However, in the case of court proceedings, these fees must not be lower than the statutory fees, and the difference is not recoverable from the unsuccessful opponent.

Where the claimant does not succeed with the entire claim, they will only recover the corresponding percentage of costs – eg, if they are 60% successful, they will recover 60% of the costs.

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

Where authorities issue decisions at any step of the product life cycle, the applicant can raise objections (Widerspruch). The timeframe for doing so will normally be one month. The authority will need to review its decision. If it agrees with the applicant, the matter will be resolved. If it concludes, upon review, that it cannot agree, the question is escalated to the authority with supervision over the original authority. If that authority denies the objection, the applicant will be free to issue proceedings in the administrative courts.

There are numerous decided court cases, particularly on questions of the classification of medicines and devices.

Declaratory Model Proceedings

German civil procedure does not permit class or group actions as seen in other jurisdictions. However, in 2018 declaratory model proceedings were introduced into the Code of Civil Procedure (Zivilprozessordnung). This type of proceeding allows certified consumer associations to seek declaratory findings on questions of fact.

These findings may be relevant for the subsequent determination of numerous individual consumer claims, and will bind consumers who had opted into the proceedings by registering their individual claim in a public claims register.

The litigation is conducted by the consumer association. The registered consumers are not parties to the proceedings. Registration in the claims register suspends the limitation period for the consumer claims registered.

There are certain requirements regarding the size and standing of consumer associations, which must:

• be non-profit organisations;
• have at least 350 members; and
• have been in existence for at least four years at the time the action is filed.

Upon filing the action, the consumer association must show that the subject matter of the action affects the claims of at least ten consumers. At least 50 consumers must then register their claims in the claims register within two months of publication of the action in order for it to proceed. Please see the Germany Law and Practice chapter in the Collective Redress & Class Actions 2021 guide for further detail.

Joint Claims

Claimants can also bring a joint claim against the same defendant(s), provided the same court has jurisdiction over the individual claims. The court can decide to separate the claims if they do not have a common background and are better dealt with separately.

It is common for party representatives to explore settlement options in informal pre-action correspondence.

Once a matter is litigious, the ZPO impose a duty on judges to explore settlement options between the parties. As a result, parties are encouraged to settle their dispute in court and formalised ADR such as mediation, which runs parallel to court proceedings, is far less common than it is in many other jurisdictions.

An unsafe product may feature in civil claims, administrative processes and even criminal proceedings. However, those three avenues have very different purposes – satisfaction of a private damages claim, safety of the public and imposition of a penalty on an offender, respectively – and can only influence each other to a limited extent.

Please see 5.2 Legislative Reform.

The European Commission has put forward a proposal for a new refreshed Regulation on product safety in line with the New Consumer Agenda. If passed, the proposed Regulation would repeal and replace the current General Product Safety Directive 2001/95/EC with a new Regulation for consumer product safety.

In 2022, the German government issued a roadmap of intended reforms in the healthcare and life sciences sector that are expected to have a significant impact on pharmaceutical and medical device companies as well as healthcare providers and technology companies.

The roadmap envisaged changes to the drug pricing and drug reimbursement rules; changes in the areas of supply of medicines, vaccines and medical devices; and enhanced digitalisation of healthcare, where Germany is perceived to be lagging behind. New rules relating to pricing and supply were passed on 23 June 2023. A draft Act relating to digitalisation was made public on 13 July 2023.

There are also plans to make amendments to other areas affecting the life sciences industry, such as food advertising and the regulation of cannabis.

Artificial intelligence in medicine is a rapidly growing field. Digitally available information is evaluated in order to assist in diagnostics and/or to recommend optimised therapies.

There is no specific national legislation regarding AI nor is there any proposed legislation in this field as relevant legislation at the EU level is expected to come into force before long: a Regulation commonly referred to as the AI Act, and a Directive on adapting non-contractual civil liability rules to artificial intelligence (the “AI Liability Directive”).

The European Parliament adopted its negotiating position on the AI Act on 14 June 2023. The proposed AI Act will establish obligations for providers and users depending on the level of risk from artificial intelligence.

The AI Liability Directive provides for two main instruments: (i) a rebuttable presumption of a causal link between the fault of the defendant and the output produced by the AI system or the failure of the AI system to produce an output, and (ii) in the case of damage caused by high-risk AI systems, access to evidence held by companies or providers is to be facilitated.