Medicinal products (including biologicals) are primarily regulated by the German Medicinal Products Act (AMG), which implements and complements the Directive 2001/83/EC on medicinal products for human use. Several German regulations connect to the AMG and stipulate further requirements on e.g. the manufacturing of medicinal products (German Ordinance on the Manufacture of Medicinal Products and Active Ingredients (AMWHV)), the wholesale of medicinal products (German Ordinance on Wholesale of Medicinal Products (AM-HandelsV)), the prescription of medicinal products (German Ordinance on the Prescription Requirement for Medicinal Products (AMVV)), the pricing of prescription-only medicinal products (RX) (German Ordinance on Medicinal Products Prices (AMPreisV)) or the compassionate use of medicinal products (German Ordinance on the Placing on the Market of Medicinal Products without Marketing Authorization (AMHV)).

Medical devices and in-vitro diagnostics are regulated by the German Medical Devices Law Implementation Act (MPDG), which complements the Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). As with medicinal products, several German regulations connect to the MPDG (and the MDR/IVDR) and stipulate further requirements on e.g. the handing over of medical devices (German Ordinance on the Handing Over of Medical Devices (MPAV)) or the operating and use of medical devices (German Ordinance on the Operation and Use of Medical Devices (MPBetreibV)).

Food is basically regulated by Regulation (EC) 178/2002 (GFLR) on the general principles and requirements of food and further EU regulations on e.g. the labelling of food (Regulation (EU) 1169/2011 (FICR)), health claims for food (Regulation (EC) 1924/2006 (HCR)), hygienic aspects of the manufacture (Regulations (EC) 852/2004 and (EC) 853/2004) or novel food (Regulation (EU) 2015/2283). Additionally, the German Food and Feed Act (LFGB) applies, as well as several German regulations stipulating further requirements on e.g. the execution of the FICR (German Ordinance on Food Information Implementation (LMIDV)) or hygienic aspects of the manufacture of food (German Ordinance on Hygienic Requirements for Food (LMHV)).

Food supplements qualify as food and, consequently all food related EU and German regulations generally apply to food supplements. Additionally, specific food supplements regulations apply, such as requirements given by the German Ordinance on Food Supplements (NemV).

Medicinal products under development are generally studied in a preclinically setting (in vitro testing or animal studies authorized under German Act on Veterinary Medicinal Products (TAMG)) before being studied in humans for safety, dose and efficacy in a clinical setting, meaning clinical trials (phases 1–3). Based on positive data obtained from preclinic and clinic, a marketing authorization necessary for placing on the market of the medicinal product can be applied for. Marketing authorization will be granted either by the European Commission with the involvement of the European Medicines Agency (EMA) (central procedure) or by the Federal Institute for Medicinal Products and Medical Devices (BfArM) or Paul-Ehrlich-Institut (PEI) (e.g. national procedure). Following the marketing authorization, the medicinal product can be placed on the market and advertising becomes permitted, albeit there are strict advertising regulations for medicinal products (see answer to question 14). Upon placing on the market of the medicinal product, the marketing authorization holder is required to meet the pharmacovigilance obligations, and the competent authorities are responsible for market surveillance. The process from R&D to placing on the market and pharmacovigilance follows AMG and further German regulations, implementing and complementing the EU regulations on medicinal products.

Medical devices under development must undergo a conformity assessment by the manufacturer to determine whether the medical device meets the applicable general safety and performance requirements for its intended purpose. Such an assessment includes the clinical evaluation of the available data and may require a clinical investigation through clinical studies or performance studies in humans. For most medical devices, a Notified Body needs to be involved in the conformity assessment. Based on a positive outcome of the conformity assessment procedure, a CE marking may be affixed to the medical device, and the medical device may be placed on the market. Upon placing on the market of the medical device, the manufacturer is required to meet the vigilance obligations, and the competent authorities are responsible for market surveillance. The process from R&D to placing on the market and vigilance follows the MPDG and the MDR/IVDR.

Before entering the German market, it is essential to determine if the product indeed qualifies as a food supplement under NemV or falls into another regulatory category, especially as a medicinal product or novel food. This classification is critical because products containing vitamins, minerals or botanicals at higher concentrations may be considered borderline products and could be reclassified by the Federal Institute for Medicinal Products and Medical Devices (BfArM) or federal food authorities. Under the Medicinal Products Act (AMG), a presumption exists that products with pharmacological, immunological, or metabolic effects may be considered medicinal, overriding a food classification, and would consequently require approval before entering the market.

Food supplements are not subject to prior marketing authorization, and the responsibility for compliance with safety, composition, labelling, health claims, and hygiene rules lies fully with the food business operator. Operators must implement HACCP (Hazard Analysis and Critical Control Point)-based risk management procedures and adhere to GLFR standards to ensure regulatory compliance and safety of the product.

Before marketing, each food supplement must be notified to the BVL (Federal Office of Consumer Protection and Food Safety), including a label specimen. This notification is formal only, and no prior assessment or approval is required. Once notified, food supplements may be marketed freely, subject to compliance with applicable law. Post-market surveillance is conducted by the local authorities of the Länder through inspections, sampling, and enforcement measures, while the Rapid Alert System for Food and Feed (RASFF) provide EU-wide coordination for unsafe products. The system therefore combines operator responsibility, formal notification, and ex post control to ensure the safety and compliance of food supplements.

The marketing authorization holder of a medicinal product is required to comply with the pharmacovigilance regulations under EU and German regulations, such as the AMG. In particular, the marketing authorization holder must establish and maintain a proper pharmacovigilance system, appoint a qualified person for pharmacovigilance (Stufenplanbeauftragter) and comply with respective documentation obligations (e.g. suspected cases of adverse events) and reporting requirements (e.g. suspected cases of adverse events or periodic safety update reports (PSUR)). Besides, the marketing authorization holder must appoint a qualified information officer (Informationsbeauftragter), who ensures compliance of the labelling, the package insert leaflets (PIL), the summary of product characteristics (SmPC) and all advertising with the marketing authorization. Furthermore, the marketing authorization holder has comprehensive notification obligations in case of changes to documents or information relating to the marketing authorization (e.g. changes of the risk profile) and, in specific cases, needs to request approval of such changes. Furthermore, the marketing authorization holder is required to conclude specific insurance regarding the product liability regime under the AMG (see answer to question 18).

For medical devices, upon placing on the market, the manufacturer must comply with the vigilance obligations stipulated in EU and German regulations, primarily under MDR/IVDR. Under MDR/IVDR, the manufacturer must establish and maintain an extensive quality management system (QMS) covering e.g. risk management (RM) and post-market surveillance (PMS). Additionally, the manufacturer must draw up and keep up to date technical documentation of the medical device. Besides, the MPDG establishes further documentation, reporting and cooperation obligations for manufacturers, particularly in relation to field actions.

For medicinal products, the Federal Institute for Medicinal Products and Medical Devices (BfArM) or the Paul-Ehrlich-Institut (PEI) are responsible for issuing marketing authorizations (except centralized procedure), approving clinical trials, and for pharmacovigilance. In general, the BfArM is responsible, unless the PEI is responsible, as it is in specific cases only, e.g. for blood products, tissues, vaccines or advanced therapy medicinal products (ATMP). The local authorities of the Länder are responsible for market surveillance and rather “place-bound” topics, such as manufacturing and wholesale distribution and inspections of premises.

For medical devices, the Federal Institute for Medicinal Products and Medical Devices (BfArM) is the federal regulatory authority and responsible for e.g. qualification and classification decisions, approvals for clinical investigations or vigilance, whereas the local authorities of the Länder are responsible for general oversight, inspections and enforcement.

The Federal Office of Consumer Protection and Food Safety (BVL) is the federal authority for food and food supplements and takes a coordinating role by e.g. participating in the preparation of general administrative regulations and monitoring programs and serving as a coordinating office for the federal states. For food supplements, the BVL receives the marketing notifications and forwards these notifications to the competent state authorities. The local authorities of the Länder are particularly responsible for market surveillance.

Decisions by regulatory authorities relating to medicinal products, medical devices, food and food supplements most likely represent administrative orders (Verwaltungsakt). Depending on the state of the issuing authority, the addressee of a decision (or in specific cases even third parties) may file an objection with the issuing authority or file a claim before the administrative court within one month after order’s notification. The administrative order may either be lifted causing the procedure to end or be upheld. In the latter case, depending on whether an objection or a claim was filed first, the addressee (or in specific cases even third parties) is entitled to file a claim before the administrative court (in case of a prior objection) or file/apply for an appeal before the higher administrative court (in case of a prior claim). If the administrative order is upheld, a (further) appeal is considerable.

Both, an objection and a claim against an administrative order have by default suspensory effect which impedes the enforcement of the order. In general, this means that an inimical administrative order (e.g. a product recall order) does not affect existing rights of the addressee (e.g. the distribution of products) for the time the order is being challenged. However, there are exemptions (e.g. cases of public interest) and, besides, the issuing authority may and in practice often does order immediate enforcement of its order for the sake of public health, meaning that neither an objection nor a claim have suspensory effect. In such cases, the addressee (or in specific cases even third parties) may apply for a restoration of the suspensory effect.

Besides, the addressee may apply for interim order before the administrative court. Such interim order might be justified if the danger exists that the enforcement of a right of the addressee could be prevented by means of an alteration of the existing state or to settle an interim condition to avert major disadvantages or prevent immanent force, or for other reasons.

Clinical trials with medicinal products are mainly governed by the Regulation (EU) 536/2014 (CTR), which contains the most substantial requirements for clinical trials, such as the submission of an application dossier through the EU Clinical Trial Information System (CTIS) containing all relevant information and documents and authorization by the Federal Institute for Medicinal Products and Medical Devices (BfArM) or the Paul-Ehrlich-Institut (PEI) after scientific and ethical review. In addition, AMG provides for complementing regulations, such as the requirement that the sponsor or its legal representative is based in the EU or EEA or that a clinical trial subject insurance is in place. It is notable, that the German Medical Research Act (MFG), which came into effect in 2024 and aims at increasing Germany’s attractiveness as a location for innovative medical research, introduced several improvements in the field of clinical trials. This included e.g. (1) a central coordination office for BfArM and PEI with the aim of coordinating and harmonizing cooperation (e.g. at scientific advice or clinical trial authorization), (2) a specialized ethics committee for complex or urgent procedures, (3) shorter procedure processing times for Germany-only clinical trials and (4) the promotion of digitalization by introducing electronic consent for participation in clinical trials.

Clinical trials or performance studies with medical devices are generally governed by the MDR/IVDR, which contain the most substantial requirements for clinical trials or performance studies such as the submission of an application through the clinical investigations and performance studies module (CIPS) of the European Database on Medical Devices (EUDAMED) containing all relevant information and documents and the authorization by the member state and the lack of a negative review by the competent ethics committee. However, it is notable that the MPDG amends and complements MDR/IVDR regulations: This includes e.g. that (1) applications for clinical trials or performance studies must be submitted through the German Medical Devices Information and Database System portal (DMIDS) given the fact that CIPS module of EUDAMED is still not functioning, (2) clinical trials or performance studies may be started in specific cases, if the BfArM did not object to an application, while a positive review by the competent ethics committee is required in all cases, (3) the sponsor or its legal representative is based in the EU or EEA or (4) a clinical trial or performance study subject insurance is in place.

Decisions by BfArM or PEI can be challenged as outlined in answer to questions 6.

For medicinal products, clinical trial information can be found in the German Clinical Trial Register (DRKS), which is operated by BfArM and represents the primary registry for clinical trials for Germany. Further, information for clinical trials under the regime of CTR is available on the CTIS, whereas information for clinical trials under the previous regime of Directive 2001/83/EC (implemented and complemented by AMG) can be found in the EU Clinical Trials Register. Also, ClinicalTrials.gov operated by the U.S. government can be used to search for clinical trials in Germany, too. Under CTR, the sponsor of a clinical trial is obliged to submit a report of the results plus a summary for laypersons within one year after completion of the clinical trial, which is then published on CTIS. For specific clinical trials (confirmatory clinical trials in non-EU third countries), the AMG stipulates further requirements.

Unlike with medicinal products, information on clinical trials and performance studies involving medical devices is currently not available in free public registries. This will change in the future once CIPS has achieved full functionality (expectedly in 2027), which will be accessible to the public. It is notable that the CIPS module will be connected to CTIS. Under MDR/IVDR, the sponsor of a clinical trial or performance study is required to submit a report of the results plus a summary for laypersons within one year after completion of the clinical trial or performance study, which is then published on CIPS accompanied by a summary written in language that is easily understandable (for laypersons).

The processing of non-anonymized data in clinical trials or performance studies must comply with the Regulation (EU) 2016/679 (GDPR) and the respective German regulations implementing and complementing the GPDR (e.g. German Federal Data Protection Act (BDSG) or federal states’ law). Besides, other EU and German regulations must be complied with, e.g. with the AMG and the MPDG. Under the last two regulations, the processing of non-anonymized data requires informed consent, notwithstanding other possible justifications (e.g. public health interests or scientific research purposes) under GDPR or BDSG, which are widely used in other countries. A secondary use of data from clinical trials generally requires informed consent and can to some extent be challenging.

With regard to a secondary use of health data in general, recent developments are notably: Both, the German Health Data Use Act (GDNG), which came into effect in 2024, and the Regulation (EU) 2025/327 (EHDS), which came into effect in 2025, allow the secondary use of data for research in specific cases and will promote such use.

Additionally, it is notable that, following the MFG, the German Ordinance on Standard Contract Clauses for the Conduction of Clinical Trials (StandVKlV) was issued. The StandVKlV contains standard contract clauses generally to be used for clinical trial agreements between sponsor and trial site for clinical trials with medicinal products, unless amended or waived by mutual agreement between the parties. Exhibit 2 of the StanVKlK contains data protection clauses based on the assumption of a joint controllership between sponsor and trial site, which have an impact on the data processing during a clinical trial. It is to be expected that similar standard contract clauses will be introduced for clinical trials or performance studies with medical devices in the future.

Under CTR and IVDR/MDR, the application for clinical trials or performance studies must be submitted digitally through the CTIS (medicinal products) or CIPS/DMIDS (medical devices) and is, therefore, already digitalized (also see answer to question 7). Under the CTR and the AMG, participants in clinical trials with medicinal products may give their consent to data processing electronically, but not their consent to participate up until the MFG came into effect in 2024. The changes by MFG in this regard significantly promote digitization. In contrast, under MDR/IVDR and MPDG it is currently not possible to give consent for participation in clinical trials or performance studies with medical devices electronically, but it is to be expected that the introduction of such electronic consent is just a matter of time. Regarding decentralized clinical trials, at the very least, the MFG has introduced the possibility of providing medicinal products (IMP) directly to participants, while the introduction of further measures would have been desirable (regarding e.g. delegation by physicians, telemedicine activities or cooperation with primary care practices).

The manufacturing of medicinal products is understood broadly (e.g. producing, processing, packaging, labelling or release of medicinal products) and requires a manufacturing license under AMG, which refers to a specific manufacturing plant, activities and medicinal products. The manufacturer is entitled to a manufacturing authorization if (1) a qualified person is available, (2) the manufacturing plant offers sufficient premises and equipment and (3) the manufacturer can ensure that the manufacturing follows current state of scientific and technical knowledge. For specific activities (e.g. extraction of blood) or specific medicinal products (ATMP) additional requirements may apply. The manufacturing authorization will be issued by the local authority of the Länder competent for the manufacturing plant’s location within 3 months from the complete application and is issued for an unlimited period but remains subject to regular inspections.

In contrast to medicinal products, the manufacturing of medical devices, food and food supplements does not require a manufacturing authorization respectively an authorized plant. However, sufficient quality of the manufacturing is indirectly ensured: For medical devices e.g. by the essential safety and performance requirements following from MDR/IVDR and complemented by MPDG and for food and food supplements e.g. by the hygiene requirements following from Regulations (EU) 852/2004 and (EU) 853/2004 and complemented by LMHV.

In Germany, the distribution of medicinal products, medical devices, and food supplements is regulated under distinct legal frameworks, with specific rules for marketing, wholesale distribution, and post-market oversight.

Medicinal products are in Germany – apart from the EU-wide centralized procedure according to Regulation 726/2004 – governed by the German Medicinal Products Act (AMG) and EU Directive 2001/83/EC and require prior marketing authorization from the Federal Institute for Medicinal Products and Medical Devices (BfArM) or, in the case of vaccines and certain biologics, the Paul-Ehrlich-Institut (PEI). Wholesale distribution is subject to the AMG (§§ 52a–52b) and requires compliance with the Pharmaceutical Trade Regulation (AM-HandelsV) regarding quality assurance and documentation and the EU Good Distribution Practice (GDP) Guidelines. Wholesale distributors must hold a wholesale authorization (§ 52a (1) 1 AMG) and comply with obligations for storage, transport, and record-keeping. The typical supply chain runs from the manufacturer through a wholesale distributor (if applicable) to pharmacies or hospitals, with dispensing to patients in general limited to pharmacies. Post-market oversight is ensured through mandatory pharmacovigilance, including adverse reaction reporting and risk management plans.

Medical devices are regulated under the EU Medical Devices Regulation (MDR 2017/745) and the German Medical Devices Law Implementation Act (MPDG), which replaced the former national Medical Devices Act (MPG). Medical Devices require a CE marking, which is provided based on conformity assessment, for most medical devices involving a Notified Body depending on the device class. Wholesale distributors must register with the competent authority and comply with MPDG requirements on traceability, documentation, and post-market surveillance. GDP-like principles may apply, especially for higher-risk devices (Class IIb/III). The typical supply chain runs from the manufacturer, through an authorized representative for non-EU products, to distributors or wholesalers, and finally to healthcare providers or end users. Post-market obligations include vigilance systems, incident reporting, and periodic safety updates under the MDR and MPDG.

Food supplements are legally classified as foodstuffs and regulated under Directive 2002/46/EC, the Nahrungsergänzungsmittelverordnung (NemV), Regulations (EC) 178/2002, (EU) 1169/2011, and (EC) 1924/2006. They do not require prior marketing authorization, but the manufacturer must ensure compliance with safety, composition, labelling, and health claim rules. Notification to the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (Federal Office for Consumer Protection and Food Safety/BVL) is mandatory before first marketing. Wholesale distribution does not require a specific authorization. However, manufacturers must comply with standard food law obligations, including traceability, hygiene, and record-keeping. The typical supply chain runs from the manufacturer through distributors or wholesalers to retailers and ultimately to consumers. Post-market control is carried out by the food authorities of the German federal countries, with unsafe products reported through the Rapid Alert System for Food and Feed (RASFF).

In Germany, the pricing and reimbursement of medicinal products, medical devices, and food supplements are regulated differently depending on the product type and its inclusion in the statutory health insurance (SHI) system.
Medicinal Products: Prescription-only medicinal products may be marketed at free prices by the manufacturer during the first 6 months after launch. After this period, reimbursement prices for SHI patients are determined through negotiations based on the Joint Federal Committee´s (G-BA’s) assessment of therapeutic benefit relative to existing therapies (§ 130b SGB V, AMNOG Negotiations) and apply retroactive from the seventh month onward.

Non-prescription medicinal products generally have free pricing. Only medicinal products listed in the SHI reimbursement catalogue are reimbursable.

Medical devices: Manufacturers generally set prices freely, except for certain high-cost devices reimbursed by SHI. Reimbursement requires inclusion in the SHI medical devices catalogue (Hilfsmittelverzeichnis) or, for hospital devices, incorporation into DRG-based budgets or separate negotiated reimbursement. SHI reimbursement often depends on a G-BA (Joint Federal Committee) assessment, followed by negotiation of maximum reimbursable amounts.

Food supplements: There is no statutory price regulation, and manufacturers or retailers may set prices freely. Food supplements are generally not reimbursed by SHI or private health insurance, except in exceptional cases such as medically prescribed nutrition therapy.

Advertising for medicinal products is regulated by the German Health Product Advertising Act (HWG). As a key provision under HWG, advertising must not be misleading. Advertising is already deemed misleading, when medical claims are made that are not supported by scientific evidence that meets the gold standard, unless this is made transparent. In addition, the HWG generally bans advertising of (1) non-authorized medicinal products (including off-label use) and (2) prescription-only medicinal products (RX) to the public, (3) strictly regulates advertising of non-prescription medicinal products (OTC) to the public and (4) stipulates the mandatory information to be presented in advertising. Besides, HWG addresses grants and benefits for healthcare professionals, teleshopping and advertising for telemedicine.

For medical devices, MDR/IVDR prohibit misleading advertising in relation to the intended use, the safety or the performance by e.g. claiming false functionality or characteristics or not providing sufficient information about risks to be expected during use. Besides, certain provisions of the HWG apply, such as the prohibition of advertising using publications whose promotional intent is misleading or concealed or advertising to minors.

Advertising for food and food supplements is addressed by EU and German regulations. Under FICR (taken up by LFGB), advertising must not be misleading in relation to e.g. the characteristics or composition by e.g. claiming false effects. For nutrition- and health-related claims, the HCR is decisive and prohibits the use of (1) ambiguous or misleading claims, (2) claims raising doubts about the safety of other products or (3) claims encouraging excessive consumption. Besides, the HCR requires that nutrition- and health-related claims are based on and supported by generally accepted scientific evidence and, additionally for health-related claims, require a prior authorization by the competent authority and listing of the respective claim in the EU community register. Further advertising regulations for food supplements follow from the NemV, which prohibits e.g. advertising using claims implying that it is generally not possible to obtain adequate amounts of nutrients through a balanced and varied diet.

It should be noted that in Germany – unlike in some other countries – no prior authorization is required for advertising of medicinal products, medical devices, food or food supplements in general. Also, besides the specific EU and German regulations, advertising generally falls under the German Act against Unfair Competition (UWG), after which additional provisions may apply, e.g. in relation to comparative advertising. In the future, once the EU green claims directive (proposal COM/2023/166 final) comes into effect, environmental-related claims will also be subject to stricter regulations and, therefore, more in focus.

In Germany, intellectual property for medicinal products, medical devices, and food supplements is governed by patent and trademark law, with specific rules reflecting the type of product.

Patents are regulated under the Patent Act (PatG – Patentgesetz) and the European Patent Convention (EPC 1973), with Supplementary Protection Certificates (SPCs) under Regulation (EC) No 469/2009 available for authorized medicinal products. Patents protect technical inventions that are novel, inventive, and industrially applicable, but mere discoveries of natural substances without inventive steps are not patentable. For medicinal products, patents are highly relevant, covering active ingredients, formulations, and methods of treatment, and SPCs can extend exclusivity beyond the standard 20-year term to compensate for regulatory delays.

For medical devices, patents may cover devices, technical components, or manufacturing methods, though SPCs do not apply. Food supplements generally have lower patent relevance; patents may be granted for innovative formulations, extraction processes, or combinations of active ingredients.

Trademarks are governed by the Trademark Act (MarkenG – Markengesetz), the EU Trademark Regulation (EUTMR) administered by the EUIPO, and the Madrid Protocol for international registrations. Trademarks protect brand identity, including product names, logos, and series marks, rather than technical inventions. For medicinal products, trademarks are highly relevant but must not mislead regarding therapeutic effects or ingredients. For medical devices, trademarks may cover device names, symbols, or branding, but claims about efficacy must not be misleading. For food supplements, trademarks can protect product names and branding, but labels and claims must comply with food law and cannot suggest medicinal benefits.

In Germany, patent infringements are primarily governed by the Patent Act (PatG – Patentgesetz), with enforcement procedures under the German Code of Civil Procedure (ZPO). A patent is infringed when a third party, without the patent owner’s consent, manufactures, markets, uses, or offers a product covered by the patent, or uses a patented process or products directly obtained from it. For medicinal products, this includes active ingredients, formulations, and methods of treatment, while for medical devices, infringement covers technical features of the device or protected methods of manufacture or use.

Patent infringement in the field of medicinal products and medical devices is handled within a structured and comparatively fast legal system that is generally considered favorable to patent holders. A key feature is the so-called bifurcated system, under which infringement and validity are decided in separate proceedings. Questions of infringement – whether a product or process falls within the scope of a patent – are decided by on patents specialized regional courts such as those in Hamburg, Munich, Dusseldorf, or Mannheim. In contrast, the validity of the patent is assessed in separate nullity proceedings before the Federal Patent Court. Because these proceedings run in parallel, it is possible that a court finds infringement and grants an injunction before the patent’s validity has been finally confirmed, a situation often referred to as the “injunction gap”.

For urgent cases, particularly common in the medicinal products and medical device sectors, patent holders can seek a preliminary injunction (PI). This is a fast-track procedure designed to provide immediate relief, for example to prevent the market entry of a generic medicinal product or to stop the presentation of an allegedly infringing medical device at a trade fair. Preliminary injunctions can be granted within a matter of days in ex parte cases or within a few months in inter partes proceedings. However, the applicant must demonstrate urgency, clear infringement, and a sufficiently secure legal position, meaning that the patent’s validity must appear highly likely. If a preliminary injunction of a district court is later overturned by the higher district court, the applicant may be liable for damages caused by its enforcement.

The main infringement proceedings (Hauptsacheverfahren) follow the standard civil litigation process and typically take around 10 to 18 months at first instance. The court will decide on infringement and establish liability for damages. The third instance of main proceedings is the Federal Court of Justice (BGH). It is important to note that judgments are provisionally executory, which means that a judgment may be carried out even while an appeal is pending, typically upon the posting of security.

As defence strategy the alleged infringer often initiates nullity proceedings to challenge the validity of the patent. These proceedings before the Federal Patent Court generally takes longer, up to two to three years. The infringement court (district court) may stay its proceedings if it considers that the patent is likely to be invalid, but such stays are granted only if invalidity appears highly probable.

Defendants in patent infringement cases typically rely on several defense strategies. They may argue non-infringement, asserting that the accused product does not fall within the scope of the patent claims, either literally or by equivalence. They may also attack the validity of the patent in nullity proceedings, for example on the grounds of lack of novelty or inventive step. A specific doctrine in German law, the so-called Formstein defense, allows defendants to argue that even if their product is equivalent, it would not itself be patentable and therefore should not constitute infringement. In preliminary injunction proceedings, defendants often challenge the urgency of the request or argue that the patent’s validity is not sufficiently certain. Additional defenses may include the existence of a license, the exhaustion of patent rights, or, in rare cases, arguments based on proportionality.

In the medicinal products sector, disputes frequently arise before a product enters the market, particularly in the context of generic medicinal products, where preliminary injunctions can effectively block market entry. In the medical device sector, litigation often occurs in connection with trade fairs, where preliminary injunctions can prevent the display or marketing of products. Importantly, regulatory approval for a medicinal product or certification of a medical device does not shield a company from patent infringement claims.

The German system is characterized by speed, specialization, and strong injunctive relief. The combination of preliminary injunctions, relatively fast main proceedings, and the bifurcated structure makes Germany one of the most important and effective jurisdictions for patent enforcement in Europe.

The Unified Patent Court (UPC), established under the UPCA (2013) and implemented in Germany through the UPC Implementation Act (2017), provides centralized jurisdiction for unitary patents and European patents opted into the UPC. Patent holders can bring patent infringement claims before the Unified Patent Court (UPC), seek declaratory judgments of non-infringement, or challenge the validity of a patent, with the decisions being binding in all participating EU member states.

German national courts retain jurisdiction over national patents and European patents not opted into the UPC, and patent holders may opt out of UPC jurisdiction for existing patents during the transitional period. Remedies under the UPC—injunctions, damages, and recall—are similar to national courts, and key defenses, including the Bolar exemption for medicinal products, remain applicable.

Accordingly, medicinal product and medical device patents can be defended in Germany either through national courts or the UPC, offering a combination of injunctive relief, damages, and product recall. Strategic advantages of the UPC include cross-border enforcement and reduced risk of conflicting national decisions.

In Germany, trademarks are protected under the Trademark Act (MarkenG) and the EU Trademark Regulation (EUTMR), but their use is subject to sector-specific legal restrictions to prevent misleading or unsafe claims. While trademarks may be registered for brand identification across all sectors, their use is strictly regulated: medicinal and medical claims are tightly controlled, and food or supplement trademarks may only use authorized health claims. Registration alone does not override sector-specific rules, and authorities -including BfArM, medical device regulators, and State Food Safety Authorities – can prohibit or sanction misleading trademark use.

For medicinal products, brand names must not mislead regarding therapeutic effects, composition or safety. Names implying unproven efficacy, cure claims, or similarity to other medicinal products may be prohibited, and the Federal Institute for Medicinal Products and Medical Devices (BfArM) can refuse marketing of medicinal products with misleading trademarks. Consequently, a registered trademark cannot be used on packaging or marketing if it violates AMG rules or risks misleading patients.

For medical devices, trademarks must not misrepresent the device’s safety, performance, or intended use. A trademark suggesting medicinal efficacy or greater effectiveness than supported by the conformity assessment may trigger regulatory enforcement, including product withdrawal.

For food and food supplements, trademarks cannot imply medicinal effects and must not be misleading about composition, nutrient content, or health benefits, under § 4 NemV and Regulations (EU) 1169/2011 and (EC) 1924/2006. Health claims used in connection with trademarks must be authorized by EFSA. For example, a trademark claiming to “cure fatigue” or “prevent disease” would be illegal even if registered. Enforcement is carried out by the BVL and other food control authorities, with courts handling civil disputes.

For medicinal products, the AMG contains a separate product liability regime, which – within its scope of application – supersedes the general product liability regime under the German Product Liability Act (ProdHaftG) implementing and complementing the Directive 85/374/EEC (PLD). The AMG product liability regime (1) addresses the pharmaceutical entrepreneur, (2) does not require default and (3) provides for a presumption of causality in specific cases, as well as (4) a patient’s right to information against the marketing authorization holder. Besides, default-based tort law claims under German Civil Code Act (BGB) are considerable.

For medical devices and food supplements, the general product liability regime under the ProdHaftG applies. The ProdHaftG product liability regime addresses the manufacturer (e.g. manufacturer, person labelled as manufacturer on the packaging or importer) and does not require default by the manufacturer. Besides, default-based tort law claims under the BGB are considerable.

It is worth noting that the current PLD will be repealed in early December 2026 by the Directive (EU) 2024/2853, which stipulates revised general product liability regulations reflecting that today’s products are more digital, more global and integrated into the circular economy. Following this, a new ProdHaftG implementing Directive (EU) 2024/2853 will replace the current ProdHaftG. The new regulations will address software (including cloud technology and AI) and updates and upgrades, as well as product upcycling. Besides, the new ProdHaftG will provide for (1) a relaxation of burden of proof in certain cases, (2) extended statute of limitations of 25 years in specific cases of injury delay (latency period cases) and (3) the requirement for courts of higher instances to electronically publish court decisions.

In Germany, the life sciences sector is subject to a combination of criminal, administrative, and civil liability, with implementation closely monitored by federal and state authorities.

Medicinal products: Criminal liability is high, covering offences such as marketing unsafe or unapproved medicinal products, falsifying products, or serious breaches of GMP or pharmacovigilance obligations, with penalties ranging from fines to imprisonment of up to 10 years in aggravated cases. Responsible persons, including management, qualified persons, and pharmacovigilance officers, can be personally liable. Administrative liability is actively monitored, including applying fines (up to €25,000 per infringement), marketing bans, recalls, and suspension or revocation of authorization. Civil liability is significant, featuring strict (no-fault) liability under the AMG (§ 84 AMG) for personal injury or death, sometimes with presumption of causation, alongside fault-based claims under the Civil Code (BGB). Enforcement practice is highly proactive, with authorities routinely inspecting GMP/GDP compliance, monitoring pharmacovigilance, and ordering recalls, while criminal investigations focus on counterfeits, illegal imports, or serious safety violations.

Medical devices: Criminal liability arises from placing non-compliant or unregistered devices on the market, unlawful clinical investigations, or counterfeiting, with imprisonment up to 3–5 years. Administrative enforcement includes fines (up to €30,000), CE marking-related actions, recalls, and prohibitions. Civil liability is based on strict product liability under the Product Liability Act (ProdHaftG) for defective medical devices, supplemented by fault-based tort claims with no statutory cap. Enforcement by regulatory authorities has intensified since MDR implementation, emphasizing documentation, clinical evaluation, post-market surveillance, and field safety corrective actions, while criminal proceedings remain relatively rare but are increasing in cases of fraud or falsification.

Foods and food supplements: Criminal liability can arise from unsafe products, fraud, mislabeling, or adulteration, including imprisonment. Administrative enforcement is frequent and robust, with fines, product seizures, destruction, recalls, and public warnings, often including reputational exposure (“naming and shaming”). Civil liability includes product liability under the ProdHaftG, tort claims, and competition law exposure for misleading claims, also by competitors in the field of HWG. Food supplements are a high-risk category due to frequent reclassification as medicinal products and strict regulation on health claims and ingredients.

Across sectors, key risk drivers include corporate and personal liability, strict liability regimes (especially for medicinal products and medical devices), and administrative monitoring. Criminal proceedings generally escalate where there is intentional misconduct, public health risk, or large-scale commercial gain. Authorities also have broad powers for recall, withdrawal, or destruction, which are commonly applied pragmatically and swiftly.

Germany provides a comprehensive, multi-layered legal framework for digital health applications, combining EU medical device law, national “DiGA” (Digital Health Application Apps) rules for reimbursable apps, and broader digital health and data legislation. DiGAs, often referred to as “prescription apps,” are certified medical devices that are prescribed by doctors and reimbursed by health insurance companies. Many apps that diagnose, treat, or monitor health qualify as software as a medical device, falling under the EU Medical Device Regulation (MDR 2017/745) and, where applicable, the IVDR. Nationally, the MDR is supplemented through the Medical Devices Law Implementation Act (MPDG). As a result, such apps require CE marking, compliance with safety and performance obligations, clinical evaluation, and post-market surveillance. The risk class of the device determines the regulatory burden, with higher-risk apps subject to stricter requirements.

Germany has also created a unique reimbursement pathway for digital health applications under the Digital Healthcare Act (DVG, 2019), integrated into Social Code Book V (SGB V) and the Digital Health Applications Ordinance (DiGAV). Reimbursable apps (“apps on prescription”) are assessed by the Federal Institute for Medicinal Products and Medical Devices (BfArM) and must be included in the official DiGA directory before physicians can prescribe them and statutory health insurance can reimburse them. Eligible apps are generally class I or IIa medical devices, with functionality primarily digital, and must demonstrate either medical benefit or positive healthcare effects. A fast-track procedure allows provisional listing while evidence is being generated. Recent legislation, including the Digital Healthcare and Nursing Care Modernization Act (DVPMG, 2021) and the Digital Act (DigiG, 2024), has expanded the scope to higher-risk apps (class IIb), integrated apps into care pathways such as remote monitoring, and reinforced statutory entitlement to digital health services.

Data protection is a central regulatory pillar, governed by the EU General Data Protection Regulation (GDPR) and Germany’s Health Data Use Act (GDNG, 2024). Apps must implement strict safeguards for processing sensitive health data, including pseudonymization, secure storage, patient opt-out mechanisms, and robust cybersecurity measures.

Advertising claims are closely monitored under the German Health Advertising Act (HWG) and competition law, with injunctive relief actions, which are often filed by competitors or consumer organizations on the grounds of unfounded or misleading statements

Germany has a well-established legal framework to ensure the continuous supply of medicinal products and medical devices, combining mandatory reporting duties, emergency powers, and implementation mechanisms. For medicinal products, the Medicinal Products Act (AMG) imposes obligations on manufacturers and wholesalers to maintain uninterrupted supply and notify the Federal Institute for Medicinal Products and Medical Devices (BfArM) of anticipated shortages, manufacturing disruptions, or export. Non-compliance can trigger administrative fines or, in serious cases, criminal sanctions. BfArM is empowered to coordinate with companies, manage redistribution, and facilitate temporary imports, particularly for essential medicinal products used in emergency care, chronic therapy, or pandemic response.

For medical devices, similar obligations are codified in the Medical Devices Law Implementation Act (MPDG), requiring manufacturers and distributors to report supply disruptions for critical medical devices, maintain traceability, and cooperate with authorities. BfArM and state authorities may request stock information and coordinate redistribution, especially for life-saving devices such as ventilators or implants.

Germany also has emergency supply provisions allowing federal authorities to intervene in distribution if shortages endanger public health. Measures include facilitating imports from other EU states and temporarily overriding distribution contracts to maintain availability.

At the EU level, Germany implements rules on falsified medicinal products, supply chain security, and mandatory reporting of shortages (e.g. Directive 2011/62/EU). Nationally, ongoing initiatives aim to further strengthen supply security through mandatory stockpiling of critical medicinal products, enhanced supply chain transparency, and digital tracking systems to detect bottlenecks.

In practice, the framework primarily affects marketing authorization holders, manufacturers, wholesalers, and importers of critical medicinal products or devices. Implementation is coordinated by BfArM, with non-compliance addressed through fines or administrative orders.

For medicinal products, the Association for Voluntary Self-regulation for the Pharmaceutical Industry (FSA) has issued codes of conduct and directives, which implement and complement the regulations given by European Federation of Pharmaceutical Industries and Associations (EFPIA) addressing the cooperation with healthcare professionals (HCPs), healthcare organizations (HCOs) or patient organizations, transparency of such and advertising and promotion of medicinal products (and to some extent DiGAs). Besides, the Association for Medicinal Products and Cooperation in the Healthcare Sector (AKG) has issued another code of conduct which aims for compliance with the applicable law when providing information or collaborating with physicians. It is notable that there are further codes of conduct which address e.g. specific areas in the industry, such as the code of the Association for Generic and Biosimilar Companies in Germany (Pro Generika).

Regarding medical devices, the Federal Association of Medical Technology (BVMed) has issued a code of conduct, which implements and complements the regulations given by non-profit organization MedTech Europe Aisbl (MedTech Europe) addressing the relationship with HCPs, HCOs and patients and transparency of such. As with medicinal products, there are further codes of conduct which address e.g. specific areas in the industry, such as the code of the Association of the Diagnostics Industry (VDGH).

It is notable that all industry codes are binding only for member companies. However, the regulations given by the codes are sometimes used as an indication when assessing the legal situation, independently of a membership.

Recent court and regulatory developments in Germany have clarified key aspects of the life sciences sector, particularly around product classification, pricing, digital health, and distribution. Notable decisions and regulatory changes include:

Court of Justice of the European Union clarification on pharmacological action (C‑589/23) – The CJEU confirmed that a product that reversibly binds bacteria to prevent adhesion should be classified as a medicinal product rather than a medical device because it exerts a pharmacological action. This ruling overturns attempts to market such borderline products as medical devices and underscores the strict EU criteria for distinguishing medicinal products from medical devices, directly impacting German companies developing innovative preventive or borderline therapies.

Federal Constitutional Court (BVerfG) on pharmaceutical cost control (16 July 2025) – The BVerfG upheld the state’s extensive GKV FinStG cost containment measures, including deep discounts and a long-standing price moratorium for medicinal products. The decision confirms broad regulatory discretion in setting reimbursement and pricing rules, reinforcing the legal basis for government interventions in the pharmaceutical market and affecting pricing strategies and market access planning for pharma companies in Germany.

Federal Court of Justice (BGH) on online pharmacy platforms (BGH I ZR 46/24, 20 Feb 2025) – The BGH held that online marketplaces can charge flat fees for listing partner pharmacies without violating the statutory ban on discounting prescription medicinal products, provided payments are not linked to prescription volume or restrict patient choice. This decision clarifies digital distribution models and the intersection of competition law with pharmaceutical pricing regulations in Germany, guiding online pharmacy platforms and healthcare marketplaces.

Higher Regional Court of Hamburg (OLG Hamburg) on medical device software (20 June 2024, Az. 3 U 3/24) – The court ruled that a teledermatology app with image upload and patient history functions should be classified as risk class IIa under MDR Rule 11, not class I, due to its diagnostic purpose. This decision has significant implications for CE marking, conformity assessment, and regulatory strategy for software-based medical devices in Germany, particularly telemedicine and AI-supported diagnostic tools.

DiGA regulatory reform (DiGAV amendment, 1 Feb 2026) – The government amended the Digital Health Applications Ordinance to require manufacturers to submit real-world performance data, periodic reports to BfArM, and compliance information under the EU AI Act for apps using artificial intelligence. These changes materially affect risk management, compliance, and reimbursement pathways for digital health applications in Germany, particularly those seeking prescription-based reimbursement under the DiGA regime.

These recent rulings and regulatory updates collectively reinforce strict product classification criteria, validate state control over pricing, clarify digital distribution rules, and enhance regulatory obligations for digital health applications. For companies in the German life sciences sector, they highlight the need for careful compliance planning around classification, reimbursement, CE marking, software risk, and ongoing post-market reporting.

Germany has established a comprehensive and evolving legal and regulatory framework to govern the digitalization of its healthcare system and the use of artificial intelligence (AI) in the life sciences sector. Central to this framework is the Digital Healthcare Act (DVG), implemented through Social Code Book V (SGB V), which created a statutory pathway for reimbursable digital health applications (DiGA for apps, DiPA – digital care applications -for care support tools). The system requires central approval and listing by the Federal Institute for Medicinal Products and Medical Devices (BfArM), demonstration of positive healthcare effects, and ongoing post-listing monitoring. Non-compliance can result in delisting, with immediate loss of reimbursement, highlighting that these obligations are mandatory.

The EU Medical Device Regulation (MDR) and Germany’s Medical Devices Law Implementation Act (MPDG) govern market access, safety, performance, and post-market surveillance for digital health applications, particularly those qualifying as medical devices, including software and AI tools used for diagnosis or therapy. Compliance with the requirements for CE marking, clinical evaluation, and risk management is mandatory, and regulators increasingly require lifecycle evidence updates for adaptive AI systems. The BfArM plays a central role in monitoring clinical evidence, safety, interoperability, and risk management.

Germany has also built a nationwide telematics infrastructure, integrating the electronic patient record (ePA), electronic prescriptions (eRezept), and secure provider communications. Health data governance is reinforced by the Health Data Use Act (GDNG, 2024), which enables pseudonymized use of patient data for research and AI development, with strict safeguards including opt-out mechanisms, ethical review, and robust security standards. These provisions support responsible AI research and the generation of real-world evidence, a key requirement for regulatory acceptance.

With respect to AI, Germany aligns with the EU Artificial Intelligence Act, treating AI used in medical devices and digital therapeutics as high-risk systems subject to mandatory risk management, transparency, documentation, clinical validation, and post-market monitoring. Regulators emphasize explainability, bias evaluation, and continuous performance oversight for adaptive AI/ML tools, and compliance with GDPR and national privacy rules is strictly enforced. National authorities, including BfArM and data protection bodies, actively audit digital health and AI implementations, with corrective measures, fines, and delistings for non-compliance.

Germany’s life sciences sector is experiencing a wave of legislative, regulatory, and market developments aimed at modernizing healthcare, integrating digitalization, and preparing for AI-driven innovations. Several key trends can be highlighted.

1. Health Data Act and National Health Data Infrastructure: The Gesundheitsdatennutzungsgesetz (GDNG, 2024) has established a national health data infrastructure, enabling structured and pseudonymized use of patient data for research, innovation, and AI development under strict privacy safeguards. As of October 2025, the German Health Data Lab at BfArM became operational, facilitating access to real-world data for scientific research, clinical evidence generation, and AI training. This reflects a strategic push to leverage data while maintaining compliance with GDPR and national governance standards.

2. Digitization of Core Healthcare Processes: Germany continues to implement its Digital Gesetz (DigiG, 2023–25), including mandatory use of the electronic patient record (ePA) for statutory insured persons with an opt-out mechanism, electronic prescriptions (eRezept), and integration of digital treatment programs. These reforms embed nationwide digital healthcare infrastructure into law, increasing interoperability and setting the stage for reimbursable digital health applications (DiGA/DiPA) under SGB V. The trend indicates a legal and operational standardization of digital healthcare, creating a unified platform for patient care and data exchange.

3. Product Liability Modernization: In September 2025, the Federal Ministry of Justice published a draft to modernize the Product Liability Act (Produkthaftungsgesetz) to cover software, AI, cybersecurity risks, and data loss in medical devices. This reform, intended to implement the EU Product Liability Directive (2024/2853), significantly broadens liability exposure for life sciences companies, particularly in medtech and digital health, reflecting a legal trend toward adapting liability frameworks to digital and AI-enabled products.

4. EU AI and Data Regulation Implementation: Germany is actively aligning its national regulations in the life sciences sector with developments at the EU level, including the EU AI Act (2024) for high-risk AI systems in healthcare, and the Digital Omnibus package (2025) to harmonize digital compliance requirements. These measures affect AI deployment in diagnostics, decision support, medicinal products discovery, and digital therapeutics, imposing obligations on risk management, transparency, clinical validation, and post-market monitoring.

These trends collectively signal Germany’s focus on digitalization, data-driven innovation, AI integration, and adaptive regulatory frameworks, creating both opportunities and compliance responsibilities for life sciences stakeholders.