In Germany, the market for medical devices is primarily regulated by Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation – MDR) and by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

The aim of the MDR and the IVDR is to ensure a high level of protection for patients and users, to ensure the smooth functioning of the internal market and to encourage innovation.

The MDR and IVDR define the regulatory requirements for medical devices, including medical instruments and personal protective equipment classified as medical devices. These requirements cover clinical and device-related evaluation, CE marking, market placement, and the post-market obligations of economic operators.

In addition to the MDR and IVDR, manufacturers in Germany must comply with national legislation. This is particularly relevant where national law specifies, supplements, or implements European requirements. The Medical Devices Implementation Act (MPDG) plays a key role by detailing the MDR and IVDR requirements for Germany. Further obligations related to the operation, use, and reporting of medical devices are governed by ordinances such as the Medical Device User Reporting and Information Ordinance (MPAIMV) and the Medical Device Operator Ordinance (MPBetreibV). In addition, technical requirements, including the Federal Office for Information Security (BSI) guidelines on IT security for medical devices, must be considered.

Unlike medicinal products, medical devices in the EU are not subject to central approval by authorities such as the Federal Institute for Drugs and Medical Devices (BfArM). Instead, manufacturers are responsible for demonstrating compliance with all legal requirements through the conformity assessment procedure, which concludes with CE marking. In Germany, the Central Authority of the German States for Health Protection in Medicines and Medical Devices (ZLG) is responsible, under Article 85 of the MDR, for assessing, designating, and notifying the competent authorities. The notified bodies conducting conformity assessments are publicly listed on the ZLG website.

Cosmetics

In Germany, the EU Cosmetics Regulation (Regulation (EC) No 1223/2009) ensures a functioning internal market for cosmetic products while providing a high level of health protection. At national level, it is complemented by the German Cosmetics Regulation, which governs market surveillance and ensures enforcement in Germany. In addition, other national laws may apply, such as the Chemicals Act, the Animal Welfare Act, the Aerosol Packaging Regulation, the Hazardous Substances Regulation, and the Prepackaged Goods Regulation. Advertising and promotional claims for cosmetic products are further regulated by Regulation (EU) No 655/2013, which sets EU-wide criteria for their justification and admissibility.

Biocides

The Biocidal Products Regulation (Regulation (EU) No 528/2012) governs the authorisation, marketing, and use of biocidal products across the EU, establishing a harmonised regulatory framework that supports the internal market and facilitates trade. The classification and labelling of hazardous properties are regulated by Regulation (EC) No 1272/2008 (CLP Regulation).

In Germany, the Biocidal Products Regulation is implemented primarily through the Chemicals Act (ChemG), which defines the competent authorities and their responsibilities. Under Section 16e of the ChemG, manufacturers, importers, and distributors must report the composition of biocidal products, including instructions for use and safety measures, to the Federal Institute for Risk Assessment (BfR). This confidential information is made available to medical professionals and poison control centres to ensure rapid and safe responses in emergencies. Additional national provisions are set out in the Biocidal Products Implementation Regulation (ChemBiozidDV).

Food Products

Food safety and quality in the European Union are governed by a set of harmonised regulations. The EU General Food Law (Regulation (EC) No 178/2002) sets out the basic principles of food law, establishes the European Food Safety Authority, and regulates safety procedures. It requires all actors in the food chain to ensure full traceability and to have crisis-management procedures in place. Regulations (EC) Nos 852/2004 and 853/2004 define general hygiene standards and specific rules for food of animal origin.

The Health Claims Regulation (EC) No 1924/2006 governs the conditions for nutrition and health claims on food products. Regulation (EU) 2015/2283 regulates the authorisation of novel foods. The Food Information Regulation (LMIV, Regulation No 1169/2011) defines labelling requirements, including ingredients, allergens, nutritional information, food imitations, and product origin, ensuring consumer transparency and safety. Regulation (EC) No 1935/2004 sets requirements for materials that come into contact with food.

At national level, the Food, Commodities, and Feed Code (LFGB) contains the basic definitions of German food law, regulates trade in food and feed, and assigns responsibilities to supervisory authorities. It also covers exemptions, criminal offences, and administrative violations. Specific hygiene regulations, particularly the Food Hygiene Regulation (LMHV), require that perishable foods be handled or marketed only by trained personnel, in accordance with EU hygiene rules.

Nutrition Supplements

Nutritional supplements are legally classified as food products and must comply with the general food law requirements. In addition, specific rules apply regarding permitted ingredients and labelling. At European level, these requirements are mainly regulated by Directive 2002/46/EC on food supplements. In Germany, the directive is implemented through the Food Supplements Regulation (NemV).

The legal framework for granting marketing authorisation of medicinal products in Germany is defined by several laws and regulations, including the German Medicinal Products Act (AMG), Regulation (EC) No 726/2004, Directive 2001/83/EC, the Narcotics Act (BtMG), and various related ordinances.

A marketing authorisation can be sought for Germany only or simultaneously for several or all EU/EEA countries (centralised authorisation). For Germany-only applications, the Federal Institute for Drugs and Medical Devices (BfArM) is usually the competent authority. Centralised authorisation, handled by the European Medicines Agency (EMA) and granted by the European Commission, is mandatory for certain products, such as biotechnologically produced medicines or orphan drugs. In these cases, BfArM experts often assist in document evaluation.

At national level, the German Medicinal Products Price Regulation (AMPreisV) governs the pricing and reimbursement of prescription-only medicines in Germany.

Blood Products

The regulatory framework for blood products in Germany is based on national and European legislation, as well as international guidelines covering collection, manufacturing and use. At national level, the German Medicines Act (AMG) and the Transfusion Act (TFG) are particularly relevant. Supplemented German Medicines and Active Substances Manufacturing Ordinance (AMWHV) and the German Medical Association’s Hemotherapy Guideline also apply.

At European level, Directives 2002/98/EC and 2004/33/EC, as well as Regulation (EU) No 536/2014 on clinical trials, apply. Compliance with EU Good Manufacturing Practice (EU-GMP) for medicinal products and active substances is mandatory. International guidelines, such as the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme combined (PIC/S) documents, provide global GMP standards and harmonise inspections of manufacturing sites. EMA publications from the Committee for Medicinal Products for Human Use (CHMP) further provide scientific recommendations on the quality, safety, and efficacy of blood products.

Together, these regulations and guidelines create a comprehensive framework that ensures the safety, quality, and efficacy of blood products in Germany.

Psychedelics

In Germany, psychedelics are generally regulated under the Narcotics Act (BtMG) and are classified into three categories. Category I substances are not marketable and may only be used with special permission from the BfArM for scientific or public-interest purposes. Category II includes marketable substances that cannot be prescribed, such as raw materials, semi-synthetics, and intermediates for pharmaceutical use or analysis. Category III lists prescription-only narcotics, whose manufacture, prescription, and dispensing are strictly controlled.

The Act on New Psychoactive Substances (NpSG) also applies to so-called designer drugs. Overall, the use of psychedelics in Germany is highly restricted and allowed only in narrowly defined medical, scientific, or research contexts.

Cannabidiol (CBD)

Since 1 April 2024, the new Controlled Cannabis Act (CanG) removed cannabis from the list of non-marketable substances under the Narcotics Act (BtMG). As a result, pure CBD is no longer subject to the BtMG. The CanG defines the conditions under which the cultivation, possession, and use of cannabis are legal.

The use of cannabis for medical purposes falls under the Medical Cannabis Act (MedCanG). The Federal Institute for Drugs and Medical Devices (BfArM) enforces the law, while state authorities monitor its medical use by doctors and pharmacies. Only physicians are authorised to prescribe medical cannabis, in accordance with § 2 of the Model Professional Code of Conduct for Physicians (BOÄ).

These products are distinct from finished cannabidiol-containing pharmaceuticals, which are subject to standard regulatory requirements and may also be eligible for early benefit assessment under § 35a SGB V.

Medical Apps, Software

Software or medical apps classified as a medical device are regulated in Europe under the Medical Device Regulation (MDR, EU 2017/745). For in vitro diagnostic software, the IVDR (EU 2017/746) applies. Key requirements include software/medical apps classification, risk assessment, preparation of technical documentation, clinical evaluation, and CE marking before marketing or use.

In addition, the software must comply with the European General Data Protection Regulation (GDPR, 2016/679), especially regarding the processing of personal health data. The Artificial Intelligence Act (AIA) introduces further requirements, particularly for software with AI functionalities.

Digital Health Application

Digital health applications must be distinguished from general health apps and IT-based methods. While the term “health app” is not protected and can be used for any application that promotes fitness or well-being, a Digital health application (DIGA) is an approved medical device with CE marking (risk class I or IIa). Its main function must use digital technology to help patients directly detect, monitor, treat, or alleviate diseases.

To qualify as a DiGA, an application must meet stringent requirements for safety, quality, and data protection, and it must demonstrate positive healthcare effects – that is, measurable benefits for patient care, such as improved health outcomes or more efficient care delivery.. Once listed in the DiGA directory of the Federal Institute for Drugs and Medical Devices (BfArM), it can be prescribed by doctors and reimbursed by statutory health insurance.

Via the BfArM fast-track procedure, eligible apps can be provisionally listed in the DiGA directory of the Federal Institute for Drugs and Medical Devices (BfArM) while additional evidence is being generated.

Telemedicine

Telemedicine applications have become an integral part of healthcare in recent years. They now play an essential role in the provision of medical services and the organisation of treatment processes.

Telemedicine in Germany has become an integral part of healthcare, supporting medical services and treatment processes. Its legal framework is comprehensive, covering medical professional law, pharmacy law, data protection, competition law, the Social Security Code, and civil law. Telemedicine is also shaped by ongoing legislative developments, such as the Digital Act (DigiG), which lifted previous limits on video consultations, and amendments to the Federal Framework Agreement for Doctors (BMV-Ä), including mandatory use of electronic patient records in video consultations.

Since 1 April 2025, up to 50% of treatment cases in a doctor’s practice can be conducted exclusively via video consultation and reimbursed by statutory health insurance, with no distinction between new and existing patients. Exceptions include emergency cases or acute referrals. Doctors may also provide video consultations outside their practice, eg, from home.

The previous ban on remote treatment has been removed. According to Section 7(4) of the German Medical Association’s Code of Conduct (MBO-Ä, 2018), exclusive telemedicine is allowed if it is medically justifiable, maintains standard care (history, diagnosis, consultation, treatment, documentation), and patients are fully informed about its limitations. Telemedicine is only excluded if information transmitted is insufficient or a personal examination is necessary. This establishes a clear professional and legal framework for telemedical services.

Wearables

Wearables are small, body-worn mobile devices, including smartwatches, smart glasses, fitness and activity trackers, and smartphones. Fitness and activity trackers are the most widely used type. Most wearables are not classified as medical devices unless they have a specific medical purpose.

Regardless of classification, wearables must comply with data protection rules (especially GDPR) when personal or health-related data is processed, as well as general product safety requirements under EU law. In this respect, Regulation (EU) 2023/988 on general product safety (General Product Safety Regulation – GPSR), which standardises basic obligations to ensure the safety of consumer products, applies. At national level, the Product Liability Act and civil law are applicable.

Stem Cells

Stem cell therapies in Germany are primarily regulated by the German Medicines Act (AMG), which covers the manufacture, testing, and use of medicinal products, including advanced therapy medicinal products (ATMPs). Minimally manipulated autologous stem cells face less strict requirements, while more extensively processed cells are subject to full pharmaceutical regulations. European rules, especially Regulation (EC) No 1394/2007 on ATMPs, provide uniform standards across the EU.

ATMPs marketed in the European Economic Area require centralised authorisation by the European Commission, following scientific evaluation by the European Medicines Agency (EMA). Two Member States act as rapporteur and co-rapporteur, with assessments reviewed by the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP). The Paul Ehrlich Institute often serves as (co-)rapporteur in this process.

In research, the Embryo Protection Act (ESchG) strictly limits the creation and use of human embryos, allowing them only for pregnancy or preservation purposes. The Stem Cell Act (StZG) permits the import and use of human embryonic stem cells for research under strict conditions; the research must have a high-level scientific purpose, no alternatives must exist, and official approval is required.

Medical Devices and Medicinal Products

Medicinal products and medical devices both serve to detect, prevent, cure, or alleviate diseases (Section 2 (1) No 1 of the AMG; Article 2 No 1 of the MDR). Due to the exclusion rule in Article 1 (6) (b) of the MDR, a product can only be classified as either a medicinal product or a medical device. The classification depends on the primary mode of action: products with a predominantly pharmacological, immunological, or metabolic effect are medicinal products, while those with a primarily mechanical or physical effect are medical devices. This assessment is objective and scientific, not based on the subjective intended purpose.

In April 2022, the Medical Device Co-ordination Group (MDCG) issued a guideline on distinguishing medicinal products from medical devices under the MDR. While not legally binding, it serves as an interpretative aid for courts.

The same distinction applies to personal protective equipment (see 1.1 Medical Devices)

Medicinal Products and Food Supplements

Distinction between medicinal products and foods is primarily based on legal definitions. Under German law, dietary supplements are classified as foods and serve to complement the normal diet of healthy individuals. Their primary function is nutritional, not the treatment, prevention, or detection of diseases.

In contrast, Section 2(1) No 1 of the AMG defines medicinal products as substances or preparations intended for use in or on the human or animal body with properties to cure, alleviate, prevent, or detect diseases or pathological conditions. This includes functional medicinal products (Funktionsarzneimittel) and medicinal products by virtue (Präsentationsarzneimittel). Presentation medicinal products are characterised by name, form, or presentation resembling a medicinal product. Classification as a medicinal product by virtue requires an overall assessment of factors shaping consumer perception, including packaging, inserts, references to pharmaceutical research, medical methods, or professional recommendations.

This distinction is particularly relevant for food supplements, which may appear medicinal due to their design. The assessment relies on the perspective of an informed, objective observer, meaning the average consumer, based on presentation, advertising, and related features.

Medical Devices

The placing on the market and commissioning of medical devices are governed by Article 5 of the MDR. A device may only be placed on the market if it complies with the applicable regulatory requirements and is safe when used as intended, properly installed, and maintained. The intended purpose is decisive, as it determines the risk classification under the MDR (Classes I–III) and the applicable conformity assessment procedure.

Medical devices must meet the essential safety and performance requirements set out in Annex I of the MDR and be safe under normal conditions of use. Harmonised standards reflecting the recognised level of technology may be used to implement and demonstrate compliance. Their application is voluntary, but it establishes a presumption of conformity and facilitates conformity assessment.

For higher-risk devices, a quality-management system is required, for which European Standard (EN) ISO 13485 may be applied. Risk-management obligations are defined in EN ISO 14971. In addition, a Person Responsible for Regulatory Compliance (PRRC) must be appointed to ensure adherence to regulatory requirements.

Labelling and package leaflets must comply with EU requirements, with particular attention to national specifications such as the use of the German language and prescribed wordings like “pharmacy only” and “unsaleable sample".

Medicinal Products

Pursuant to Section 13 of the German Medicines Act (AMG), the manufacture of medicinal products including blood products generally requires official authorisation. “Manufacture” is defined in Section 4 No 14 of the AMG and includes extraction, production, preparation, processing, repackaging – including filling – packaging, labelling, and release of medicinal products. Section 13 of the AMG establishes this licensing requirement as a general rule while providing statutory exceptions, in paragraphs 1a and 2. The competent authority for granting manufacturing licences is specified in Section 13 para 4 of the AMG. Licences are personal and granted to the respective applicant.

According to Section 9 (2) of the AMG, the establishment of a branch or the formation of a company in Germany, in another Member State of the European Union, or in a signatory state to the Agreement on the European Economic Area is required if the medicinal product is to be placed on the market in Germany.

The import of medicinal products from third countries outside the European Union or the European Economic Area is also subject to a licence (Section 72 of the AMG). The rules applicable to manufacturing licences apply accordingly to import authorisation.

Cosmetics

The manufacture of cosmetic products must comply with Good Manufacturing Practice (GMP) under Article 8 of Regulation (EC) No 1223/2009. GMP sets binding requirements for quality assurance in production processes and storage, ensuring the consistent quality and safety of cosmetic products. Pursuant to Article 8(2), compliance with GMP is presumed if manufacturing follows the relevant harmonised standards published in the Official Journal of the European Union. German National Standard (DIN) EN ISO 22716 “Cosmetics – Good Manufacturing Practice (GMP) – Guidelines on Good Manufacturing Practice” may be applied as a recognised standard. Compliance with GMP is subject to official supervision by the competent health authorities of district-free cities and counties.

Biocides

A manufacturing authorisation is not required. However, according to Article 17 of Regulation (EU) No 528/2012 (Biocidal Products Regulation), biocidal products may only be placed on the market or used if they have been authorised in accordance with this Regulation.

Foods and Food Supplements

The relevant food law regulations outlined in 1.2 Healthcare Products must be followed for the production and marketing of food products. Commercial trade also requires proper registration of the business with the competent trade authority. Food supplements are subject to the same food law rules. Unlike medicinal products, they do not require prior official authorisation before marketing. However, they must be notified to the Federal Office for Consumer Protection and Food Safety before being placed on the market for the first time. Registration with the competent trade authority is also required for their distribution.

For further information, see 2.4 Marketing and Sales and 2.6 Post-Marketing Obligations, Including Corrective Actions and Recalls.

Corporate responsibility for environmental and sustainability issues has gained increasing importance in the European Union. The European Green Deal supports the transition to a climate-neutral economy, covering financial market regulation, energy, transport, trade, industry, agriculture, and forestry. The original target of reducing CO₂ emissions by 40 % by 2030 compared to 1990 levels has been strengthened to 50–55 %.

Sustainability requirements also apply to product design. Key regulations include the Restriction of Hazardous Substances (RoHS) Directive on the restriction of hazardous substances, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, and specific limits such as for lead in PVC. Waste management obligations complement these requirements: the Waste Electrical and Electronic Equipment Regulations (WEEE) Directive obliges manufacturers to take back and dispose of waste equipment in an environmentally sound manner, while the Waste Framework Directive aims to minimise production waste and avoid single-use products. Article 17 of the EU Medical Devices Regulation governs the reprocessing of medical devices, assigning responsibility for safety to manufacturers.

The cosmetics and food sectors are similarly affected. The EU Regulation on deforestation-free products (EUDR), gradually entering into force from 30 December 2025, requires companies to verify that imported raw materials – such as palm oil, cocoa, or soy – do not involve illegal deforestation and to ensure deforestation-free, legally compliant supply chains.

In addition to environmental obligations, companies are subject to human rights due diligence requirements. Since 1 January 2023, the German Supply Chain Act regulates corporate responsibility for compliance with human rights and environmental standards throughout global supply chains. It applies to companies with at least 1,000 employees, covering both their own operations and direct or indirect suppliers. Compliance is monitored by the Federal Office for Economic Affairs and Export Control (BAFA). The objective is to promote fair globalisation that benefits supply chain workers, companies, and consumers alike.

The current governing coalition implemented a reform of the Supply Chain Act. Under the reform, the reporting obligation was removed, and only serious violations, such as human-rights breaches, are subject to sanctions.

Medicinal Products and Medical Devices

Advertising of medicinal products and medical devices is governed by the Act on the Advertising of Medicinal Products (HWG), the MDR, the Unfair Competition Act (UWG), and professional regulations such as the Medical Association’s Professional Code. These rules primarily address promotional activities.

Advertisements must not be misleading, including claims of guaranteed success, the absence of adverse effects, or unproven effects. They must not include assessments by non-professionals or references to telemedicine. Advertising of unauthorised medicinal products or prescription-only medicines to the general public is prohibited.

For medical devices, Article 7 of the MDR requires that promotional material be truthful, clear, and not create unjustified expectations regarding performance or safety.

All advertising rules apply equally to online promotion.

Cosmetics

Regulation (EU) No 655/2013 sets criteria for cosmetic product advertising. Claims must be truthful, verifiable, fair, transparent, and understandable, enabling informed consumer decisions. Advertising may not rely solely on legal compliance, and the assessment is based on the perception of the average consumer. Non-binding guidance is provided in the European Commission’s Guidelines to Commission Regulation (EU) No 655/2013.

Food Products and Food Supplements

Section 11 of the German Food and Commodities Act (LFGB) prohibits misleading advertising of food products and supplements, including false claims of health or nutritional effects. Voluntary information on nutritional values or health effects may be used in advertising, subject to Regulation (EU) No 1924/2006 on nutrition and health claims.

Medicinal Products

A medicinal product may only be marketed after approval by the competent federal authority. The pharmaceutical company must initiate this process by submitting an application supported by comprehensive evidence of the product’s quality, safety, and therapeutic efficacy. This includes expert evaluations summarising preclinical and clinical study results, as well as documentation on post-marketing safety monitoring (pharmacovigilance). The competent authority must decide on the application within seven months.

Traditional herbal medicinal products may be marketed under this designation only if registered with the competent supreme federal authority (Section 39a of the AMG). This simplified procedure requires less extensive toxicological and clinical evidence than regular marketing authorisation.

Most homeopathic products are not subject to formal marketing authorisation but undergo a registration procedure with the German Federal Institute for Drugs and Medical Devices. The manufacturer must provide documentation and expert assessments demonstrating that the product is manufactured in accordance with the German Homeopathic Pharmacopoeia and that its quality and safety are adequately assured. Safety may be presumed if the preparation is sufficiently diluted, and proof of therapeutic efficacy is not required for registration.

Medical Devices

A prerequisite for placing medical devices on the market is the proper implementation of the procedure provided for in the MDR. This includes the successful completion of the conformity assessment procedure.

Medical devices may only be marketed if their safety and performance have been verified in advance. This verification is carried out as part of the conformity assessment procedure initiated by the manufacturer. It determines whether the product meets the basic requirements for safety and reliability. Only after successful completion of the conformity assessment may a medical device be affixed with the CE marking. This marking indicates that the product is freely marketed within the European Union.

Unlike for medicinal products, the CE marking does not constitute state approval. The conformity assessment procedure is carried out with the participation of a so-called notified body. This is an independent testing organisation that does not, however, have any sovereign powers. The manufacturer is free to choose the notified body.

The conformity assessment is conducted with the participation of a notified body, an independent testing organisation without sovereign powers, which the manufacturer may freely choose. The specific requirements depend on the device’s risk class. For Class I devices, notified-body involvement is generally not required, but the manufacturer must comply with Article 52 (7) of the MDR and maintain technical documentation demonstrating conformity.

Beyond EU requirements, German law does not provide for independent approval procedures. Economic operators, defined in Article 2(35) of the MDR, including manufacturers, authorised representatives, importers, and distributors, are responsible for placing devices on the market and making them available.

Food Supplements

Food supplements are generally classified as food products under EU law and are therefore not subject to the regulatory approval system for medicinal products. No prior authorisation is required to place them on the market.

However, the initial marketing of a food supplement must be reported to the German Federal Office of Consumer Protection and Food Safety. The product must be pre-packaged and may contain only the vitamins and minerals listed in Annex I of Directive 2002/46/EC, in the chemical forms specified in Annex II, and meeting the legally prescribed purity standards.

Marketing is also conditional upon compliance with the labelling requirements set out in applicable EU and national legislation.

Cosmetics

Since 2013, the sale of cosmetic products or ingredients tested on animals for the purpose of complying with EU cosmetics legislation has been prohibited in the European Union.

Cosmetics may only be marketed if their safety is ensured. Prior to placing a product on the market, a safety assessment must be conducted by a competent person, covering advertised properties, skin compatibility, and shelf life. The manufacturer is responsible for ensuring compliance with all legal requirements.

After market launch, cosmetic products are subject to ongoing supervision, with competent federal state authorities conducting random checks to ensure compliance.

Biocides

Biocidal products may only be placed on the market after official approval has been granted. The applicable approval procedure depends on the product and the number of Member States in which it is to be sold.

For distribution within a single Member State, national approval is sufficient. For marketing in multiple Member States, mutual recognition of an existing national approval may be sought.

The Biocidal Products Regulation also provides an EU-wide approval procedure, allowing companies to obtain authorisation in a single step. For certain biocidal products, particularly those without substances of concern, a simplified approval procedure is available.

The approval and market launch of the products described in 1 Applicable Product Safety Regulatory Regimes are mainly based on EU requirements. In Germany, for example, additional requirements apply to drug approval that goes beyond EU regulations. These additional requirements ensure high standards but also provide transparent and reliable guidelines that clearly define market conditions. The strict regulations also help to strengthen the trust of doctors, pharmacies, and end consumers, which can significantly increase a product's market presence.

In contrast, the legal framework for advertising drugs and medical devices in Germany is relatively moderate compared to international standards. In particular, no prior official review of advertising measures is required. Violations of the German Drug Advertising Act (HWG) are typically detected only afterwards, for example if a competitor challenges the advertising through legal action.

Medicinal Products

Pursuant to the Medicinal Products Act (AMG), marketing authorisation holders are obliged continuously and systematically to collect and evaluate all information arising from the use of their medicinal products. In this context, the holder must establish and maintain an appropriate pharmacovigilance and risk management system. This obligation applies to all finished medicinal products placed on the market in Germany.

The Pharmacovigilance Division of the BfArM continuously monitors known adverse reactions and interactions associated with medicinal products and ensures that patients, healthcare professionals, and other stakeholders are duly informed of identified risks and the measures available to mitigate them.

Medical Devices

The same principles apply to medical devices. Manufacturers are required to establish an appropriate post-market surveillance system in accordance with the device’s risk classification. Within this system, all information regarding the performance, quality, and safety of the device must be systematically collected, recorded, and analysed. The results may be documented in a post-market surveillance report or, where applicable, in a Periodic Safety Update Report summarising the findings of the post-market surveillance activities.

In Germany, due to its federal structure, various authorities are responsible for overseeing and regulating medicinal products. These authorities collaborate under the Central Office of the Federal States for Health Protection of Drugs and Medical Devices (ZLG), which ensures compliance with manufacturing standards and continuous monitoring of ongoing clinical trials.

The responsibilities for medicinal products are distributed across several higher federal authorities, including:

• The Federal Institute for Drugs and Medical Devices (BfArM), responsible for the approval and supervision of low-molecular and biotechnologically manufactured medicinal products, as well as medical devices.
• The Paul Ehrlich Institute, which regulates biological products such as vaccines, advanced therapy medicinal products (eg, gene and cell therapies), and blood and tissue preparations.
• The Federal Office of Consumer Protection and Food Safety, which oversees the approval and monitoring of veterinary medicinal products.

At the central level, the Federal Institute for Drugs and Medical Devices assumes the following key responsibilities:

• The approval of medicinal products, including those in specialised therapeutic areas such as phytotherapy, homeopathy, and anthroposophic medicine.
• The registration of homeopathic and traditional herbal medicinal products.
• The collection, assessment, and risk management of medicinal products, in line with pharmacovigilance requirements.
• The centralised collection and evaluation of risks related to medical devices.
• The monitoring of the legal circulation of narcotics and precursor substances.

These tasks are essential for ensuring that medicinal products and medical devices in Germany adhere to high safety, quality, and efficacy standards, thus safeguarding public health.

For medical devices, the responsibility for assessment, designation, and notification to the relevant bodies lies with the Central Authority for Health Protection of Drugs and Medical Devices (ZLG), as stipulated by Article 85 of the MDR. A list of the designated and notified bodies can be found on the Central Authority's website. The Central Authority is also responsible for all the conformity assessments required under the MDR.

The requirements for the respective product category from Section 1 are enforced in Germany by the competent authority by issuing an administrative act. An administrative act is a sovereign measure of public administration that is issued to regulate an individual case in the field of public law and has direct legal effect externally.

For example, the approval procedure for a medicinal product is based on the principle that marketing is prohibited without prior authorisation. A medicinal product may be placed on the market only after a positive overall assessment. The marketing authorisation granted under Section 21 of the AMG constitutes an administrative act within the meaning of Section 35 of the Administrative Procedures Act (VwVfG). If it is subsequently determined that the approval requirements are no longer met, or were never met, the competent authority may withdraw or revoke the authorisation by means of an administrative act pursuant to Section 30 of the AMG.

With regard to non-compliance with the applicable regulations for the product categories set out in Section 1, national legislation supplements the relevant EU requirements.

For medicinal products, the Medicinal Products Act (AMG) provides for additional criminal offences and fines, in particular in Sections 95 to 97.

For medical devices, the Medical Devices Implementation Act (MPDG) is applicable. Sections 92 and 93 of the MPDG define criminal offences punishable by fines or imprisonment, for instance where a device bearing a CE marking is placed on the market without completion of the required conformity assessment procedure.

In the field of cosmetics, Section 8 of the Cosmetics Regulation (KosmV) establishes criminal liability for intentional or negligent breaches of Regulation (EC) No 1223/2009.

Sections 58 and 59 of the Food and Feed Code (LFGB) govern criminal provisions in connection with violations of food law.

The Product Liability Act applies to all of the previously mentioned product categories, with the exception of medicinal products. According to this Act, the manufacturer is liable for any damage resulting from a defect in their product that causes death, injury to a person's body or health, or damage to another item. Product defects under the Product Liability Act include design defects, manufacturing defects and instruction defects.

In addition to the manufacturer, liability under the Product Liability Act extends to the so-called “quasi-manufacturer” (anyone who presents themselves to the public as the manufacturer), as well as to importers and suppliers. However, pursuant to Section 15 of the Product Liability Act, the law does not apply to medicinal products. For these products, strict liability under Section 84 of the Medicinal Products Act (AMG) applies instead.

Other claims for compensation, including contractual or non-contractual claims against the manufacturer or other parties, remain unaffected by the Product Liability Act. Contractual claims may arise from warranty rights or guarantee agreements, while non-contractual liability may arise under tort law pursuant to Sections 823 et seq of the German Civil Code (BGB). Unlike in the Product Liability Act, any such liability generally requires fault and may arise from the violation of a product-monitoring obligation.

For information on technological developments in connection with product liability, see 5.3 Impact of Artificial Intelligence.

In order to assert claims in court, the injured party must file a lawsuit. The lawsuit must comply with the formal requirements set out in the applicable rules of civil procedure.

As of 1 January 2026, a new value threshold will apply, determining the jurisdiction of district courts in civil matters. Pursuant to Section 23 of the Court Proceedings Act (GVG), the previous limit of EUR5,000 will be increased to EUR10,000. This change applies to all proceedings filed on or after 1 January 2026, in accordance with the transitional provision of Section 44 of the Introductory Act to the Courts Constitution Act (EGGVG).

If the district court acts as the court of first instance, an appeal may be lodged with the regional court. If the decision is made by the regional court, the appeal is directed to the higher regional court.

Judgments of the appellate court may be subject to revision, with the Federal Court of Justice (BGH) having exclusive jurisdiction in civil matters. A revision is only admissible if expressly permitted in the appellate court’s judgment.

There is a key distinction between an appeal and a revision:

• In an appeal, both the factual and legal aspects of the case are reviewed.
• In a revision, only legal errors are examined. The factual findings of the lower court are accepted as correct, provided they were made without procedural defects and are not contested.

The costs of legal proceedings consist of two main components: the out-of-court costs and the court costs.

Lawyers' Fees

Lawyers' fees (out-of-court costs) are calculated in accordance with the Lawyers' Fees Act (RVG), including the schedule of fees (VV-RVG). Lawyers may also charge fees higher than those specified by law, provided that this has been agreed with the client in a written fee agreement.

Court Costs

Court costs are calculated based on the Court Costs Act (GKG) and the Schedule of Costs (KV-GKG). Court costs are incurred for the conduct of the proceedings and cover, among other things, the organisational expenses of the court.

Amount in Dispute as the Basis for Calculation

The amount in dispute or value of the matter forms the basis for calculating both the lawyer's fees and the court costs. The amount corresponds to the economic “monetary value” of the matter in dispute.

Advance Payment of Court Costs

At the beginning of civil proceedings, the court usually charges an advance payment of court costs to pre-finance the expected court fees and any expenses incurred (for example, postal deliveries, experts, or witness compensation). The party initiating the proceedings (plaintiff) is generally obliged to pay. Without payment of the advance, the next steps in the proceedings are often not carried out – in particular, service on the opposing party only takes place after the payment has been received.

Obligation to Bear Costs

The obligation to bear costs regulates which party must bear the costs after the conclusion of court proceedings.

In principle, the losing party bears both the court costs and the out-of-court costs. If a party loses only partially, the costs are distributed according to a corresponding ratio. If the lawyer's remuneration has been individually determined in a fee agreement, the losing party usually only has to pay the statutory fees.

The competent authorities generally enforce their decisions by means of administrative acts.

For example, if the competent authority denies approval of a medicinal product by means of an administrative act, the affected person or company may first lodge an appeal with the authority that issued the act. The authority then examines the admissibility and merits of the appeal and issues a corresponding decision, either upholding or rejecting it.

If the appeals authority rejects the appeal, it is possible to file a lawsuit before the administrative court.

In many cases, immediate legal action may also be necessary, particularly if the authority has declared the administrative act immediately enforceable. Such proceedings serve to suspend enforcement of the act temporarily until a final decision is rendered.

In Germany, there is no traditional class action procedure as found in the US system. Instead, various collective legal enforcement mechanisms exist, which differ significantly in their structure and effects.

Forms of collective enforcement in Germany include:

Association Lawsuits

Qualified consumer associations can assert injunctive relief, or removal claims if companies violate consumer protection laws. These lawsuits serve the purpose of collective protection, but do not lead to individual claims for damages.

Model Declaratory Action

Since 2018, consumer associations have been able to file a lawsuit to clarify fundamental questions of fact and law for many affected parties. Those affected must actively register (opt in) in a lawsuit register. The judgment is binding on the parties but does not replace individual actions for performance; these must then be brought separately.

Action for Remedy

Introduced by the Consumer Rights Enforcement Act (VDuG) in October 2023, this action allows, for the first time, collective claims for performance, including claims for damages or contract rescission. The action operates on an opt-in basis and may only be brought by qualified entities.

Model Proceedings for Capital Investors (KapMuG)

Specifically for capital market cases: fundamental issues are decided by a higher regional court and are binding for all pending proceedings.

Qualified Entities

Association-based collective redress procedures are conducted by specially authorised, independent entities. These entities represent the collective interests of those affected, co-ordinate legal enforcement, and take on the litigation.

A legal dispute can also be resolved through a settlement, either in court (Sections 278, 160, 794 of the German Code of Civil Procedure – ZPO) or out of court (Section 779 of the German Civil Code – BGB).

Pursuant to Section 278 of the ZPO, the court is obliged to encourage an amicable settlement of the dispute, or of specific points of contention, at every stage of the proceedings. For this reason, the oral hearing is usually preceded by a conciliation session (Section 278 (2) of the ZPO), during which the court advises the parties to seek a mutually agreeable resolution.

In addition, Section 279a of the ZPO provides for the possibility of using mediation as a means to achieve an amicable settlement.

The various liability mechanisms – in particular civil product liability, regulatory measures for product-safety supervision, and criminal sanctions – each pursue different objectives and are anchored in clearly distinct legal regimes. While civil law primarily serves to protect individual rights and compensate for damages, product-safety law pursues preventive purposes and focuses on averting danger and ensuring compliance with statutory safety requirements. Criminal investigations, on the other hand, are aimed at sanctioning particularly serious violations and ensuring general prevention. Against this background, the proceedings are conducted separately and not combined to guarantee fully both the functional separation of the areas of law and access to a fair trial in each area.

Although the systems are strictly separated from each other in legal terms, there are occasional interactions in practice. For example, official findings or measures – such as recalls or warnings in the context of market surveillance – can be used as circumstantial evidence or evidence in civil proceedings. The same applies to findings from criminal investigations, which may serve as circumstantial evidence of a product defect or negligent behaviour.

There is also no formal link between civil claims for damages and criminal prosecution. In practice, however, aggrieved consumers or their representatives sometimes threaten criminal proceedings in order to lend weight to civil claims. However, such action has no effect on criminal proceedings, as law enforcement authorities are obliged to investigate independently and exclusively in accordance with the law. There is therefore no systematic “pressure mechanism” between civil and criminal law.

See 5.2 Legislative Reform and 5.3 Impact of Artificial Intelligence.

Reform of the EU Medical Devices Regulation (MDR)

On 16 December 2025, the European Commission presented a proposal to amend the EU Medical Devices Regulation (MDR). The aim of this proposal is to respond to existing structural deficiencies in the regulatory framework while improving the efficiency, digitalisation, and innovation-friendliness of the MDR. Particular attention is being paid to creating simplifications for low-risk medical devices that have been on the market for a long time, known as “well-established technologies.”

The key reform measures include:

• Abolishing the maximum validity period for certificates in order to avoid recurring re-certifications and increase predictability for manufacturers.
• Reduced involvement of notified bodies in the conformity assessment of Class IIa and IIb medical devices, allowing lower-risk products to be approved more quickly.
• Support for micro and small enterprises, for example through reduced fee rates for notified bodies and lower clinical evidence requirements, in order to lower barriers to innovation.
• Introduction of structured dialogue and real-world laboratories to facilitate practical exchanges between authorities and manufacturers and better address regulatory challenges.

Overall, the European Commission's proposal aims to make the MDR more efficient, business-friendly, and conducive to innovation without compromising the fundamental safety and quality standards for medical devices.

Digitalisation – Electronic Patient Record (ePA)

Digitalisation in healthcare is being driven forward in order to make processes more efficient and improve patient care. A key element of this is the electronic patient record (ePA).

From 1 January 2026, all software systems in use must have a certificate of conformity for the use of ePA and thus be “ePA-ready.” Physicians who use systems without this certification will no longer be able to bill for their services (Section 372 (3) of the Fifth Book of the Social Code – SGB V).

The Medical Research Act (MFG)

The Medical Research Act came into force on 30 October 2024 and serves to improve the framework conditions for medical research, development, approval, and manufacture of medicinal products and medical devices in Germany and to strengthen Germany as a research location by accelerating and reducing the bureaucracy of regulatory procedures. In particular, it integrates and harmonises approval and radiation protection procedures, shortens the deadlines for mono-national clinical trials, and creates uniform responsibilities for the approval authorities, including the centralisation of certain procedures at the Federal Institute for Drugs and Medical Devices. The law provides for the establishment of a specialised ethics commission at the federal level, promotes digitised application processing and the possibility of agreeing on confidential reimbursement amounts for drugs with new active ingredients under certain conditions, and creates the legal basis for the publication of standardised contract clauses for clinical trials in order to simplify negotiation and approval processes. The aim of the regulations is to increase the competitiveness of the German research and development sector in human medicine with clear, faster, and legally harmonised procedures, without sacrificing the high level of protection for study participants and patients.

Medical Devices Operator Ordinance (MPBetreibV)

The amended Medical Devices Operator Ordinance (MPBetreibV) recalibrates the duties of operators of medical devices and related software in response to the growing reliance on digital and networked technologies. Its regulatory reach has been broadened to include additional product categories, accompanied by updated legal terminology. Operators are required to establish appropriate technical and organisational safeguards to ensure the safe use of software-driven medical devices, including the verification of the IT environment prior to use, the continuous deployment of security-related software updates, and renewed staff training following material system changes. For applications associated with elevated risk, the ordinance further mandates periodic IT security evaluations conducted by suitably qualified experts. These measures are intended to reinforce patient safety in an increasingly digital healthcare landscape.

Supply of Medicinal Products

Significant changes are planned for the supply of medicinal products from 2026 onwards, which are intended to improve the clinical trial process and co-operation between federal authorities.

Standard Contract Clauses for Clinical Trials

Since the entry into force of the Standard Contract Clauses Regulation on 18 December 2025, binding standard clauses governing the rights and obligations of sponsors and trial centres have applied. The regulation aims to simplify and accelerate contract negotiations prior to the initiation of clinical trials. This facilitates a faster start to clinical testing and enhances overall efficiency in the development and supply of medicinal products Establishment of a co-ordination office between BfArM and PEI:

To improve co-ordination between the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), a co-ordination office will be set up at the BfArM. This office is intended to make co-operation between the two authorities more efficient, simplify administrative processes, and better co-ordinate technical issues without compromising the independence of BfArM or PEI. This will take into account the ongoing development of innovative drugs and combination therapies and support the industry in planning clinical trials.

Regarding the Extension of the national Product Liability Act see 5.3 Impact of Artificial Intelligence.

EU-AI Act

The use of artificial intelligence (AI) in medical devices is becoming increasingly important and, since August 2024, has been subject to the provisions of the EU AI Act (Regulation (EU) 2024/1689) in addition to medical device law. This regulation supplements existing regulatory frameworks and is relevant whenever AI models are part of a medical device or are themselves placed on the market as medical devices.

The aim of the EU AI Act is to harmonise the responsible development and use of innovative AI-based applications within the European Union. The regulation creates a legally secure and harmonised basis for the use of AI systems and is intended to promote innovation while ensuring a high level of protection for health, safety, and fundamental rights.

The regulations on so-called high-risk AI systems are central to AI-supported medical devices. According to Article 6 (1) (a) of the EU AI Act, AI systems are considered high-risk if they are used as a safety component of a product that falls under the MDR or if the AI system itself constitutes such a product. This applies to AI-based medical devices that are classified as Class IIa, IIb, or III medical devices in accordance with Rule 11 of Annex VIII MDR, as well as Class I medical devices with a measuring function.

These high-risk AI systems are subject to the comprehensive requirements of Articles 8 to 15 of the AI Regulation. These relate in particular to risk management throughout the entire life cycle of the system, appropriate data governance to ensure data quality and representativeness, the creation of detailed technical documentation, and recording and logging obligations. In addition, transparency requirements must be met, and users must be provided with sufficient information for safe use. Other key requirements concern ensuring human oversight and guaranteeing the accuracy, robustness, and cybersecurity of AI systems.

Extension of the Product Liability Act

Rapid technological development, in particular the increasing use of software and artificial intelligence in products, has pushed existing product liability law to its limits. The current Product Liability Act was primarily designed towards physical products and was unable to cover digital, self-learning, and networked systems adequately. To close these regulatory gaps and align national law with the requirements of the EU Product Liability Directive 2024/2853, the Federal Ministry of Justice and Consumer Protection has presented a draft bill to modernise the Product Liability Act.

According to current plans, the new Product Liability Act is scheduled to come into force on 6 October 2026. A key aspect in the draft bill is that software and AI systems are explicitly included in the scope of product liability. In future, digital products will be subject to liability rules, regardless of whether they are installed locally, operated in the cloud, or used as part of a physical product.

The legislator has deliberately refrained from providing a definitive definition of the term “software” in order to keep the regulation open to future technological developments. Examples include operating systems, firmware, applications, and AI systems. Purely digital content without any functional product reference and mere source code, however, are not to be covered. For AI-based products, this means that adaptive and self-learning systems may also be considered products relevant to liability law.

The draft bill also significantly expands the range of potentially liable parties. In addition to the manufacturer of the end product, manufacturers of components and providers of “connected services” may be held liable.

This is particularly relevant for AI systems that regularly rely on external data sources, cloud infrastructures, or continuous services and digital services that are essential to a product’s safety or functionality. Under certain conditions, providers of such services may share liability with the product manufacturer for any damage that occurs.

The draft bill significantly broadens the understanding of the defectiveness of digital products. Liability is no longer limited exclusively to the time of placing on the market, but extends to the period during which the manufacturer continues to exercise control over the product, for example through updates, upgrades, or the operation of digital interfaces.

AI Systems and Data Protection

The use of AI systems in medicine has a significant impact on data protection requirements, as their performance depends directly on the quality and scope of the data used. Since this data often comes from user information, databases, and, in the future, will come from electronic patient records and the European Health Data Space, its processing is regularly associated with personal information. For the development and application of medical AI systems, it is therefore essential to comply with data protection regulations, which form the legal basis for the processing of personal data. The AI Regulation itself does not contain any independent data protection regulations, which means that the protection of personal data continues to be guaranteed, in particular by the General Data Protection Regulation.