Healthcare: Medical Devices 2024 Comparisons

In Germany, a member state of the EU, the applicable product safety regimes are determined by the Medical Devices Regulation (EU) 2017/745 (MDR) and, covering in vitro diagnostic medical devices, by the IVD Regulation (EU) 2017/746 (IVDR). MDR and IVDR govern the entire life cycle, from the devices’ investigation (trial) stage and their subsequent CE-marking, all the way to their placing on the market and related post-market obligations. To bring legacy medical devices (CE-marked under the previous regime of the Medical Devices Directive 93/42/EEC) in conformity with MDR, manufacturers may take advantage of extended transition periods (based on Regulation (EU) 2023/607). Legacy devices may be placed on the market without completed recertification under MDR/IVDR until the end of 2027 or 2028 at the latest, provided certain requirements have been timely met. Comparable extended transition periods apply to legacy IVD medical devices.

For specific aspects not uniformly regulated for the EU as a whole by MDR/IVDR, the German Medical Devices (EU) Law Implementing Act (Medizinprodukte-Durchführungs-gesetz – MPDG) provides for specific rules. For example, the details of clinical investigations, including ethics committee approvals, are determined by MPDG. In addition, MPDG upholds the general prohibition on making devices available on the market or putting them into service when there are reasonable grounds to suspect that users are exposed to safety risks that are unacceptable according to acknowledged scientific standards. Moreover, certain distribution activities are specifically regulated based on the German Dispensing of Medical Devices Ordinance (Medizinprodukte-Abgabeverordnung – MPAV).

Cosmetics

Harmonised EU law applies in Germany as well as provided for by the Cosmetics Regulation (EC) 1223/2009. Some minor areas where EU law does not claim exclusive jurisdiction are regulated by the German Cosmetics Ordinance (Kosmetikverordnung). Companies manufacturing cosmetics in Germany have to file a notification with a German federal agency. Specific information elements on the product labels have to be in the German language (including instructions on particular precautions and the product’s intended function, amongst others).

Biocides

Again, harmonised EU law applies, ie, the Biocidal Products Regulation (EU) 528/2012. A few legislative gaps are filled by German Biocide Law Implementation Act (Biozidrechts-Durchführungsverordnung – ChemBiozidDV).

Food Supplements and Food for Medical Purposes

The multitude of food categories (cereals, meat, milk, dairy products, just to name a few) are in many respects subject to harmonised EU law, foremost the Basic Food Law Regulation (EC) 178/2002 and the Food Information Regulation (EU) 1169/2011. Also, when focusing on food categories related to human health, in addition to specific EU laws, specific German regulations apply in parallel.

Food (or dietary) supplements are governed by the European Food Supplement Directive 2002/46/EC, which in Germany is complemented by a national Food Supplement Ordinance (Nahrungsergänzungsmittelverordnung– NemV). The latter imposes on all food business operators, including distributors, resident in Germany that market food supplements the obligation to file a notification to a federal agency. Foods associated with special nutrition or health benefits may sometimes consist of novel or bio-engineered ingredients and may thus be subject to the Novel Food Regulation (EU) 2015/2283. If special vitamins or minerals are added to food (fortification), Regulation (EC) No 1170/2009 has be observed, and additionally in Germany the National Ordinance on Vitaminised Foods (Verordnung über vitaminisierte Lebensmittel– LMvitV).

Some foodstuffs may be intended for infants and young children or constitute food for special medical purposes or be used for total diet replacement and weight control, and these are all governed by Regulation (EU) 609/2013. In addition, the German Ordinance on Food for Special Consumer Groups (Lebensmittel für bestimmte Verbrauchergruppen-Verordnung– LMBVV) has to be taken into account, eg, when marketing baby formula.

Pharmaceuticals

The German Drug Act (Arzneimittelgesetz– AMG) constitutes the principal piece of legislation implementing the cornerstone EU law on drugs, ie, the Medicinal Products Directive 2001/83/EC. In parallel, for a large number of more innovative drugs or drugs indicated for certain serious diseases, applicable marketing authorisation procedures (managed centrally by the European Medicines Agency (EMA)) as well as some other aspects are governed by Regulation (EC) 726/2004.

Various ordinances issued by the executive branch provide additional detail and fill legislative spaces left by EU law. Manufacturing is governed by the Medicinal Products and Active Ingredients Manufacturing Ordinance (Arzneimittel- und Wirkstoffherstellungsverordnung– AMWHV), which is intertwined with the GDP Guideline 2013/C 343/01 published by the EU Commission. Certain aspects of wholesaling and good distribution practices (GDP) are subject to the German Medical Products Trading Ordinance (Arzneimittel-Handelsverordnung – AM-HandelsV).

Special aspects are addressed by further national legislation, such as the administering of vaccines within the framework of officially recommended vaccination plans (Sec. 21 of the Infection Protection Act –Infektionsschutzgesetz– IfSG) or the rollout of national compassionate use programmes (governed by the Medical Products Case Hardship Ordinance – Arzneimittel-Härtefall-Verordnung– AMHV). The determination of the Rx (prescription only) status of medicinal products is controlled by the German Medical Products Prescription Ordinance (Arzneimittelverschreibungsverordnung– AMVV).

Blood Products

AMG applies to blood products as well. Some particularities are covered by special provisions, eg, articles of AMG implementing the Official Control Authority Batch Release (OCABR) framework. The collection of blood from donors is regulated by the Transfusion Act (Transfusionsgesetz– TFG) which defines special safety standards to which blood collection centres are subject. TFG governs medical aspects of administering blood products to patients as well, such as meticulous record-keeping on each individual blood product (including lot numbers) applied to patients.

Psychedelics

The German Controlled Substances Act (Betäubungsmittelgesetz – BtMG) provides extensive lists of controlled substances comprising both narcotic drugs and psychotropic substances. The international foundation of the legislation was created by United Nations Conventions of 1961 (Narcotics) and 1972 (Psychotropics). Medicinal products, such as painkillers, may at the same time be classified as controlled substances. For their import and distribution, special permits have to be obtained from a federal agency in addition to the import and distribution authorisations that are applicable to medicinal products as a whole.

Medical Apps; Software

Medical software including medical apps is subject to the umbrella category of medical devices and therefore governed by MDR, or IVDR as the case may be. Regulatory details can often be taken from a set of guidance documents published by the Medical Devices Co-ordination Group, foremost MDCG 2023-4 (on medical software/hardware combinations), 2020-1 (on the clinical/performance evaluation of medical software), 2019-16 (on cybersecurity) and 2019-11 (on the qualification and classification of software).

Within the context of reimbursement granted by public health insurers, medical apps may be eligible for reimbursement on according prescription by doctors provided such apps have been approved as so-called DiGAs (Digitale Gesundheitsanwendungen – digital health applications). Approval is regulated by the German DiGA Ordinance (DiGAV) and granted by a federal agency (G-BA). Medical software may fall within the definition of AI (artificial intelligence) systems and accordingly come under the new EU AI Act. For details on the distinction between medical apps and software-driven wearables used for lifestyle purposes, see 1.5 Borderline Products on borderline definitions.

Telemedicine

Whereas, prior to 2019, physicians had in principle been prohibited from providing remote medical consultations, the law has since been liberalised (Sec. 7(3) of the Model Professional Rules – MBO/Ä). For a considerable number of indications suitable for remote appointments, face-to-face appointments are no longer mandatory. Against the backdrop of 90% of the population being insured with public (statutory) funds, and eligibility of telemedicinal services for reimbursement, a special legal framework applies to the digital platforms and video/audio channels that enable remote medical consultations, governed by social security law (Fed. Umbrella Agreement / Physicians – BMV/Ä, Exhibits, 31, 31b). Specifically, data privacy and security certifications have to be obtained by the operators of such telemedicine platforms.

On the basis of extensive legislation (recently the Digitalisation in Healthcare Acceleration Act – DigiG), the nationwide rollout of electronic prescriptions (E-Rezept) is progressing. E-prescriptions can be redeemed in pharmacies by using special apps, working in conjunction with the patients’ health insurance cards connected with the app through near-field communication. Also, Rx drugs may be obtained from mail-order pharmacies via remote sales, including e-pharmacies located in the Netherlands, which command a portion of the market share.

Wearables

Wearables (eg, pulse meters) are generally understood as portable applications connected to sensors capable of measuring body functions, providing associated readings and generating digital advice derived therefrom. They are intended for fitness and lifestyle purposes, as opposed to medical diagnosis or therapy. Such wearables are not medical devices but are subject to general product laws such as the General Product Safety Regulation (EU) 1025/2012.

It may sometimes be challenging to delineate where such wearables differ from medical devices. ECG readings of an individual person’s heart rhythm registered by a smartwatch may not be plausibly associated with a mere lifestyle use and therefore be reasonably qualified as medical devices. Whereas manufacturers in principle enjoy free discretion to subjectively determine the intended purpose, a lack of plausibility bordering on arbitrariness will limit this discretion (cf. German Fed. Supr. Court, ruling of 4/18/2009 – I ZR 53/09).

Medical Devices Versus Pharmaceuticals

Both medical devices and pharmaceuticals are used to medically diagnose or treat individual persons, so they have a medical purpose in common. Per its definition, however, a medical device’s principal mode of action is neither pharmaceutical nor immunological nor metabolic, although such active principle may assist the device’s function. Accordingly, the intended mode of operation of devices is physical or thermal or the application of air pressure. For instance, wound dressings containing antiseptic substances are usually still medical devices. The same applies to heparin-coated stents. If the device component is incorporated into a pharmaceutical, however, and merely functions as a container or drug-dispensing instrument (eg, prefilled syringes or pens for drug injection), the combined product is a pharmaceutical. Medical devices may consist purely of substances (fluids, liquids), eg, eye drops for hydration. For some substance-based products such as colon cleansing solutions, classification is controversial.

Med Software, Apps Versus Lifestyle Wearables

See 1.4 Technologies and Digital Health.

Pharmaceuticals Versus Food Supplements

A product’s qualification as a medicinal product (a.k.a. pharmaceutical) may be caused by a pharmacological function of its active substance (triggering molecular processes within the body) if it actually has a significant physiological effect beyond the mere metabolisation of nutrients and normal digestion. A product taking this route to pharmaceutical classification is referred to as a medical product by (virtue of) function (Funktionsarzneimittel).

Another way that an ingestible product can acquire a qualification as a pharmaceutical is merely based on its presentation regardless of whether or not it produces any actual pharmaceutical effects in the body. This category (pharmaceuticals by virtue of presentation – Präsentationsarzneimittel) may encompass nutritional products presented as tablets, capsules or liquids in measured doses that provide a concentrated source of nutrients. If such products, believed to be food supplements, are accompanied by promotional claims (typically displayed on the labels) suggesting that medical conditions or diseases can be cured, such medical claims not only contravene advertisement law but also switch the category from food supplement to medical product by virtue of presentation. Such mislabelled tablets, capsules or liquids purporting to cure diseases neither possess the marketing authorisation required for pharmaceuticals nor are eligible for one. Consequently, such products are not legally marketable right from the start.

Medical Devices

Whereas the general rule pursuant to MDR, Annex I, sec. 1 globally requires manufacturers to ensure that their devices are designed and manufactured in such a way that they are effective and safe and thus suitable for their intended purpose, manufacturers may accomplish this goal by observing harmonised technical standards that have been promulgated – available as (EN) ISO standards – for a multitude of device categories and characteristics. The most significant standard is ISO 13485:2016 on the quality management (QM) system for medical devices. Except for devices of pure risk class I, which is the lowest risk category (eg, surgical gloves, hand-pushed wheelchairs, stethoscopes), ISO 13485-conformity of the QM system has to be audited and certified by a Notified Body, ie, a for-profit technical auditing organisation ultimately accredited by the government. However, the manufacturing of devices does not require any manufacturing or establishment licences issued by a governmental authority.

Pharmaceuticals and Blood Products

In contrast to devices, a manufacturing licence is required as mandated by Sec. 13 AMG in adoption of harmonised EU law. The licence also covers the compulsory batch release. Since imported medicinal products manufactured in third (non-EU/EEA) countries need to be analytically tested and batch-released in the EU before becoming eligible for being placed on the German or EU market, manufacturing licences are combined with import licences, and referred to as manufacturing and import authorisations (MIAs), cf. Sec. 13, 72 AMG. MIAs are specific to a defined premises.

To obtain an MIA, apart from a QM system guaranteeing GMP compliance, a qualified person (QP) with special expertise in pharmaceutical quality management has to be appointed and notified to the competent authority. QPs are particularly responsible for batch release. Blood products require an additional batch release by a designated regulatory authority, referred to as an Official Control Authority Batch Release (OCABR). MIA-holding manufacturers need to demonstrate compliance with the body of GMP rules compiled in the EudraLex Volume 4 guidelines published by the EU Commission. Local German authorities will inspect the sites and issue separate GMP certificates.

Cosmetics

Manufacturers of cosmetic products are also bound by GMP (Art. 8 of Regulation (EU) 1223/2009), but the standards defining cosmetics GMP are less elaborate and detailed compared with pharmaceutical GMP. ISO 22716:2007 on cosmetics GMP has evolved into a generally respected standard. Neither certification by a Notified Body nor acquisition of a governmental licence is required.

Biocides

Although there is no need for a manufacturing licence, the placing on the market of biocides requires a product-related marketing authorisation in Germany conferred by the designated federal agency (see 2.4 Marketing and Sales).

Food Supplements and Food for Medical Purposes

Food business operators, including manufacturers of nutritional supplements or food for medical purposes, are required to implement a quality system known as HACCP (Hazard Analysis and Critical Control Points). Implementation of HACCP indicates compliance with relevant hygiene standards (statutory basis: Reg (EG) 852/2004). In supplementation, the German Food Hygiene Ordinance (Lebensmittelhygiene-Verordnung – LMHV) addresses further details, for example, standards for the use of potable water for food processing purposes.

Intended as a landmark piece of legislation across all industry sectors, ie, not limited to the healthcare industry, the Act on Corporate Due Diligence Obligations in Supply Chains (Gesetz über die unternehmerischen Sorgfaltspflichten in Lieferketten– LkSG) entered into force on 1 January 2023. LkSG applies to companies based in Germany including branch offices exceeding the threshold of 1,000 employees. LkSG imposes extensive due diligence and risk management obligations that aim to prevent or reduce risks related to damage to the environment, risks in the field of violations of human rights (as set out in 11 referenced international Conventions), risks of supporting child or forced labour, and risks in areas such as workplace safety, adequacy of wages, right to unionisation, illegal land grabs or denial of food and water.

The entire supply chain has to be screened (including the behaviour of contract partners and (indirect) suppliers) and risks ascertained, assessed and rated. Periodical reports have to be generated and submitted to a federal agency, BAFA, which has the competence to order certain disclosures and inspect business records. Failure to comply with these obligations can trigger fines amounting to up to EUR8 million, or 2% of annual global turnover, the latter being applicable to companies exceeding an annual turnover of EUR400 million. LkSG partly overlaps with and pre-empts the Corporate Sustainability Due Diligence Directive (CS3D) adopted at EU level.

Both medical devices and pharmaceuticals, as well as cosmetics legitimately claiming an ancillary medical effect, are subject to the German Medical Products and Services Advertisement Act (Heilmittelwerbegesetz – HWG). As a general rule, HWG prohibits all misleading advertisement claims, regardless of whether they are directed at patients/consumers or at healthcare professionals. Notably, if a certain effectiveness, scope of indications or low rate of side effects is claimed, a reversal of the burden of proof applies when claims are challenged in court, eg, by competitors or fair trade practice watchdog organisations. This means, rather than by default the plaintiff having to prove that a particular promotional claim is false, the defendant (advertiser) has to prove that the claim is accurate and backed by clinical evidence. Such evidence may usually only be derived from clinical studies.

Any advertisement of drugs prior to obtaining a marketing authorisation is forbidden. The same applies to the promotion of a drug for indications and routes of administration not covered by the marketing authorisation (off label). Pursuant to the Drug Act, marketing authorisation holders (referred to as pharmaceutical entrepreneurs in Germany) have to appoint an adequately qualified individual, called an Information Officer (Informationsbeauftrager), who is tasked with reviewing and pre-approving all advertisement materials so that the conditions of SmPC-compliance and absence of misrepresentation are fulfilled.

Comparable rules apply to medical devices, where the German HWG legislation has largely been replaced by the universal advertisement provision of Art. 7 MDR. Whereas prior to MDR’s date of application (26 May 2021), off-label advertisement for medical devices had arguably been feasible to some extent, under MDR the situation has been aligned with the ban on off-label advertisement applicable in nearly the same way to pharmaceuticals. However, manufacturers of devices, in contrast to pharmaceutical entrepreneurs, are not under a statutory obligation to designate an Information Officer.

Advertisement of Rx drugs to non-healthcare professionals is prohibited outright. Over-the counter drugs may be advertised to patients, but some restrictions apply, eg, it is prohibited to engage celebrities to recommend a drug, to specifically direct advertisement messages to minors below the age of 14, or to offer prize draws or raffles to promote drugs if such may incite excessive drug use. Drugs approved for certain indications (addictive diseases with the exception of nicotine addiction, and pregnancy complications) must not be advertised to patients. Medical devices are not captured by these special HWG rules that apply to the direct-to-patient promotion of over-the-counter drugs.

In Germany, a special “anti-gift” law applies, provided for by Sec. 7 HWG, which is in practice highly relevant. Sales of medical devices or pharmaceuticals must not be promoted by way of offering or granting free benefits (items or services) priced above EUR1 to EUR5, depending on the particular case. For Rx drugs subject to uniform pricing rules, no discounts are permissible whatsoever. The “anti-gift” law applies to benefits given to HCPs as well, but breaches do not automatically imply committing bribery.

The advertisement of cosmetics is largely guided by the same principles as are applicable, with regard to the prohibition of misleading claims, to devices and drugs. The requirements for the advertiser to substantiate and prove effectiveness claims (eg, in the field of cosmetic wound care) are not as high as in the field of drugs and devices, such that clinical studies do not always mark the benchmark of evidence. Apart from the German Act Against Unfair Trade Practices (UWG), cosmetics advertising is specifically regulated at EU level, notably by Regulation (EU) 655/2013 on common criteria for the justification of claims for cosmetic products and a related 2017 technical document on cosmetic claims. Health and nutrition claims are strictly regulated, reducing permitted claims to an inventory of pre-phrased language and narratives, as determined by the Health and Nutrition Claims Regulation (EC) 1924/2006.

As a common denominator of all healthcare product categories including medical devices, advertisement claims or materials are not pre-reviewed and/or approved by any regulatory authority in Germany. Indeed, except for drastic cases when misleading advertisement messages give rise to public health hazards, regulators refrain from intervening and leave the levelling of the playing field to the market itself. This self-regulation implies that companies are widely making use of the option to send warning letters and obtain injunction orders from courts, if competitors are found to be in breach of advertisement restrictions. To some extent, consumer protection watchdog organisations add to such efforts.

Medical Devices

Whereas no governmental marketing authorisations have to be obtained for placing medical devices on the market, manufacturers (who might to a wide extent contract out physical manufacturing and thus are called “legal manufacturers”) have to carry out a regulated conformity assessment procedure (CAP) as a precondition of legitimately affixing a CE-mark. The CE-mark functionally replaces a marketing authorisation and allows for the marketing of devices throughout the EU plus the EEA.

The key components of the CAP consist in drawing up extensive sets of technical documentation, covering the devices (and their design, testing and manufacturing) (MDR Annex II) as well as post-market surveillance activities (Annex III). Those “TDs”, including the clinical evaluation as a critical element, as well as the QM system, have to be audited by a Notified Body unless pure class I devices are involved. Only the issuance of a specific certificate by the Notified Body (attesting to MDR/IVDR conformity) covering classes Ir, Im, Is, IIa, IIb and III allows legal manufacturers to self-award a declaration of conformity and affix the CE-mark.

The German MDR implementing law (MPDG) provides a fast-track path to obtain special marketing authorisation from the federal drug and devices agency in cases where a specific device may be urgently needed (cf. Art. 59 MDR). According to MPDG, information on the label or in the instructions for use has to be provided in the German language. However, devices intended for use by healthcare professionals may be accompanied by information in English with the exception of safety-relevant instructions to be presented in German.

In addition to legal manufacturers (identical with CE-mark holders), further so-called economic operators involved in the supply chain are subject to regulatory obligations imposed by MDR and IVDR. Apart from EU-authorised representatives (to be designated by legal manufacturers not based in the EU or EEA), importers and distributors are independently charged with numerous obligations to guarantee product safety, including verification of proper CE-marking and availability of instructions for use and keeping registers of non-conforming devices. Economic operators, except distributors, have to self-register in the EudaMed database, creating transparency on roles and responsibilities, and the types of devices made available on the market.

German medical devices law (Sec. 83 MPDG) maintains a special obligation already in force under the pre-MDR legislation: if informing or instructing healthcare professionals on the proper use or application of medical devices, the (sales) representatives assigned with this task (Medical Devices Adviser –Medizinprodukteberater) have to demonstrate a certain level of qualification. Such qualification can be obtained by completing university studies or acknowledged vocational training programmes in a scientific, technical or IT-related subject, or by experience gathered on the job during at least one year in a position closely connected with the category of devices concerned. The employer of Medical Devices Advisers has to arrange for regular ongoing training so that the Advisers’ knowledge remains up to date.

Medical Apps and Software

Medical apps and other (stand-alone) software are medical devices, and as such subject to the same conformity assessment and CE-marking requirements as applicable to medical devices in general (see above). For the majority of apps/software, the CAP requires the involvement of a Notified Body assigned with auditing the QM system and the technical documentation, and issuing certificates confirming MDR conformity. The reason for the compulsory Notified Body involvement can be found in classification Rule 11 of Annex VIII to MDR, providing that software intended to furnish information which is used to take decisions for diagnostic or therapeutic purposes is classified as class IIa, at least. Class IIa devices, being above class I, may only be CE-certified based on a Notified Body audit.

Pharmaceuticals

Any placing on the market of ready-made medicinal products is subject to holding a marketing authorisation (MA). Depending on the category of medicinal products, MAs are granted centrally by the EMA effective for all of the EU, or by national drug agencies, in Germany the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte– BfArM), which is competent by default unless the Paul-Ehrlich-Institut (PEI) claims a special competence (eg, for vaccines, allergens, and blood and tissue products). National MA applications, submitted to BfArM or PEI, are usually framed within decentralised procedures (DCP) or mutual recognition/repeat use procedures (MRP/RUP) where a series of MAs for the same type of medical product is applied for in parallel, or sequentially, in different EU member states. MAs have to be renewed after five years. MAs may be transferred to a new marketing authorisation holder (MAH) provided the new MAH demonstrates compliance with regulatory responsibilities incumbent on MAHs such as pharmacovigilance.

Pharmacies which manufacture ready-made medical products (prescribed by doctors on a regular basis) themselves do not require an MA if they limit their output to a quantity of 100 packages daily. This special exemption in conditioned, however, on such pharmacies performing the essential manufacturing steps “in-house” on the pharmacy’s premises. Mere final processing (such as encapsulation or tableting) of active ingredients and excipients which the pharmacy purchased as ready-made raw materials does usually not suffice to be legally acknowledged (by the courts) as essential manufacturing steps conducted “in-house” by the pharmacies.

Cosmetics

No marketing authorisations are required for cosmetics, on either the EU or the national level in Germany. Nevertheless, manufacturers, importers or distributors of cosmetic products – whoever has to assume the role of responsible person – have to perform a safety assessment demonstrating that the products are safe for human health when used under normal or reasonably foreseeable conditions, cf. Sec. 3 of Regulation (EU) 1223/2009. Results are to be recorded in a safety report whose structure is determined by Annex I to said Regulation. Cosmetics must not contain prohibited substances, more than 1,000 of which are itemised in Annex II. A large number of other substances are subject to restrictions when added to cosmetics. Responsible persons have to prepare a product information file (PIF) available to regulators for inspection. Responsible persons have to notify their products through the Cosmetic Products Notification Portal (CPNP).

Biocides

To place biocidal products on the market, an MA is mandatory. Acquiring such MA is a two-step procedure. First, the active substances have to be approved EU-wide for use in predefined categories of biocidal products. Second, a dedicated MA has to be obtained for the product. In Germany, national MAs are granted by a federal agency known as BAuA. Alternatively, for all of the EU, MAs may be obtained from the EU regulator ECHA. For biocides with a low risk profile, a fast-track marketing authorisation procedure is available. In Germany, pursuant to a special EU biocidal law implementation ordinance (ChemBiozidDV), certain types of biocides (insecticides, rodenticides, antifouling products) must not be distributed by way of self-service. Distributors have to demonstrate certain levels of expertise to sell such more risk-prone biocidal products.

Food Supplements and Food for Medical Purposes

As a general rule, for marketing foodstuffs, including food supplements, no product-related approvals or marketing authorisations are necessary. As an exception to the rule, so-called functional foods containing ingredients considered as new (novel) require a prior marketing authorisation as Novel Foods based on Regulations (EU) 2015/2283 and (EU) 2017/2469. Foods for special medical purposes or infant formula may contain such ingredients. A comprehensive EU list of approved novel food ingredients has been published, which is updated from time to time.

Germany takes a fairly moderate approach towards using the remaining margins of discretion left to national legislatures or agencies to add regulatory obligations exceeding the harmonised level of EU law. For instance, promotional claims or marketing materials are not pre-assessed or approved by any regulators. The country’s decentralised administrative structure protects to some extent against dependencies on one central national regulatory agency where powers and competences are concentrated. The absence of class actions in the area of product liability coupled with rather swift and inexpensive judicial proceedings creates a relatively predictable business environment.

Medical Devices

Legal manufacturers have to draw up a post-market surveillance plan which already forms a part of the technical documentation required for conformity assessment and thus CE-marking purposes. Post-market, such plans have to be diligently followed through, including the collection of reports of adverse events from the field to be assessed. Any serious incidents, as they are called, that are ascertained have to be reported to the competent authority, in Germany BfArM (see 3.1 Regulatory Authorities). If risks are identified, the manufacturer will have to initiate a corrective action implemented through a filed safety notice (a “dear doctor” letter if addressed to healthcare professionals). Some less imminent risks may be controlled by providing additional instructions to users; others require the withdrawal or recall of affected devices from the market as remedial actions.

Apart from individual serious incidents, trends (ie, observed increases in the number of non-serious incidents) also have to be reported to the regulator. For devices risk-classed IIa or higher, manufacturers have to additionally prepare and submit periodical safety update reports (PSURs). In order to prevent a “data freeze” of the clinical outcomes that had powered the clinical evaluation and thus CE-marking, manufacturers may have to carry out post-market clinical follows-ups (PMCFs) based on an appropriate plan. Collection and continuous assessment of PMCF data helps to maintain an adequately up-to-date level of safety data.

The proper discharge of post-market surveillance as well as incident and trend reporting obligations are to be supervised by a special qualified representative whom manufacturers have to appoint, ie, the so-called Person Responsible for Regulatory Compliance (PRRC). The PRRC is further tasked with managing and ensuring MDR conformity of the technical documentation and performing checks on the QM system.

Pharmaceuticals

Pharmacovigilance (PV) is one of the key responsibilities of marketing authorisation holders (ie, pharmaceutical entrepreneurs, as they are referred to in Germany). Pharmaceutical entrepreneurs have to implement and operate a PV system in conformity with the detailed rules provided by the EU PV framework, as determined by a substantial body of PV legislation (Directive 2010/84/EU; Regulations (EU) 1235/2010 and 520/2012) as well as an extensive modular set of PV Guidelines published by the EMA.

PV responsibilities include maintenance of a PV system master file (PSMF), collection and evaluation of adverse events recorded in the field, global literature review for adverse events, signal detection, reporting of adverse events to regulators, regular compilation and submission of PSURs, implementation of risk management plans, and facilitation of PV inspections by authorities.

For medicinal products approved centrally by the EMA, pharmaceutical entrepreneurs whose registered place of business is in Germany have to appoint a European QPPV (qualified person for pharmacovigilance) responsible for all PV-related processes. For medical products marketed under national MAs (granted by BfArM or PEI), a German equivalent of a QPPV has to be designated by pharmaceutical entrepreneurs, referred to as the graduated plan officer (Stufenplanbeauftragter). Amongst other tasks, it falls within the responsibility of the Stufenplanbeauftragter to decide on the sustainability of a favourable risk-benefit ratio in the event of repeated serious adverse events being recorded, and submit any recommendation of potential recalls to the executive management level. Since PV responsibilities have to be complied with 365 days a year and around the clock, deputies of QPPVs and Stufenplanbeauftragte should be designated.

Unrelated to the PV responsibilities incumbent on pharmaceutical entrepreneurs, under the German medical professional ethics code, physicians are encouraged to report adverse drug events to a special drug safety board with the federal medical chamber, which regularly publishes alerts on undesired side effects, or “red-hand letters”, as they are called.

In Germany, being a federal state, authorities can be assigned to two layers of government: first, the federal level claiming jurisdiction for Germany as a whole, and second, the level of the 16 separate German states. The states, eg, Bavaria, North Rhine-Westphalia, etc, are further subdivided into districts, counties and larger cities where authorities with their respective local jurisdictions are established.

On the federal level, BfArM is competent for granting national marketing authorisations for most medicinal products as well as clinical trial approvals. BfArM is involved in co-ordinating activities aiming to control and contain any drug safety risks. Further, BfArM registers compassionate use programmes and monitors drug supply shortages. PEI has special competences for vaccines, allergens, ATMPs, blood and tissue products, and stem cells. In the medical devices sector, BfArM will deliver borderline demarcation decisions (eg, device or pharmaceutical), approve DiGA health apps and issue special fast-track device approvals replacing CE-marks. Notifications of food supplements (see 1.2 Healthcare Products) have to be submitted to the Federal Office for Consumer Protection and Food Safety (BVL).

In each of the 16 states (Länder), a multitude of district-level or local (municipal) supervisory authorities are responsible for issuing MIAs (manufacturing/import authorisations) and WDAs (wholesale distribution authorisations), as well as GMP and GDP certificates. It further falls within the remit of those state-level authorities to conduct on-site inspections and respond to public health risks and other relevant product non-conformities associated with the commercialisation of health products, be they pharmaceuticals, medical devices, biocides, food supplements or cosmetics.

Regarding medical devices, Notified Bodies are not governmental authorities although they command comparable powers and competences. Nevertheless, their relationship with manufacturers is based on contract and governed exclusively by civil law.

German authorities, on both the federal and state levels (including districts and municipalities), exercise their competences by means of so-called administrative acts (Verwaltungsakt). Administrative acts are binding and enforceable single-case orders. For instance, if a district authority reasonably suspects that a medical device or a pharmaceutical product causes an unacceptable risk to the health or wellbeing of patients, whilst the manufacturer or entrepreneur fails to properly address the risk scenario, the authority will issue an order (administrative act) instructing the companies concerned to suspend distribution or conduct a recall. Authorities may also order the disclosure of documents or the delivery of samples. Companies receiving such administrative acts have the right to file objections within one month upon service.

Authorisations and licences (MAs, MIAs, WDAs) are conferred by regulators by way of administrative acts. If an authority unjustly refuses to grant an authorisation/licence that was filed for, issuance may be claimed, and if the refusal prevails, the authority can be sued for decreeing an according beneficial administrative act.

Whereas the bulk of regulatory and safety obligations across all healthcare product categories (medical devices, pharmaceuticals, cosmetics, food) are set forth by harmonised EU legislation, German implementing laws (MPDG, AMG, KosmV, LFGB) provide a multitude of provisions that translate failures to comply with specific obligations – if intent or negligence is involved – into criminal offences or misdemeanours. If a violation of a defined regulatory prohibition or non-compliance with a particular obligation gives rise to a criminal offence, only individual persons (such as the CEO or the marketing director) can be prosecuted, not the company as a corporation. Fines for misdemeanours (a.k.a. administrative offences) may also be imposed on companies. Illustrative (non-exhaustive) examples of criminal offences (including felonies) in the medical devices sector are provided by the following statutory provisions:

• Sec. 92(1) No. 2; 12 No. 1 MPDG: Placing medical devices on the market, putting them into service or operating them if there are reasonable grounds to suspect a lack of safety that exposes patients or users to a health risk to an extent not tolerable according to medical standards.
• Sec. 93(2) No. 1 MPDG; Art. 7 MDR: Using claims, texts or figurative representations which may mislead users or patients with regard to a device’s intended purpose, safety or performance.
• Sec. 93(2) No. 3-6: Placing devices on the market, putting them into services or affixing a CE-mark to them without having performed an appropriate conformity assessment procedure in accordance with MDR.

Germany transposed the Product Liability Directive 85/374/EEC into German law, enacting the Product Liability Act (Produkthaftungsgesetz – ProdHaftG). All healthcare product categories fall under ProdHaftG, ie, medical devices, food, cosmetics and biocides, except for pharmaceuticals, which are subject to a distinct national strict product liability regime (Sec. 84 et seq. AMG). Germany had already adopted this special concept of strict liability for defective drugs in 1976 as a consequence of the thalidomide tragedy (Contergan Skandal), a spike in birth defects caused by the side effects of a sedative prescribed during pregnancy.

As far as ProdHaftG is concerned, manufacturers (producers) are liable for damage (physical injuries, damage to property) caused by defective products. Products are considered as defective if they do not satisfy the safety characteristics to be reasonably expected from the category of products in question. Defects not only may arise from actual functional shortcomings, eg, mechanical malfunctions or degradation of materials, but may also encompass insufficient instructions for use (not containing a specific warning). German courts established the theory (confirmed by the European Court of Justice) that a corrective action initiated to address a residual risk of device malfunction (which only a fraction of a percent of devices in the field may actually be affected by) causes the entire series of devices to be deemed defective (including the 99.x% actually free from any defect). This liability for suspected defects will aggravate liability exposure in the event of serial damages.

Apart from manufacturers (which had actually produced the product, or marketed the product under their own label), importers are liable for defects after having brought the product originating from a third-country (overseas) manufacturer into the EU. Distributors are not liable unless they fail to disclose the manufacturer or the importer upon request by the claimant. Essentially, claimants can be assigned to two groups. First, patients or consumers may allege that they sustained physical injuries or a deterioration of their health caused by a defective product, usually claiming damages for pain and suffering. Second, health insurers that covered the medical expenses for treating patients or consumers injured by defective products may sue the manufacturer (or importer or distributor, as the case may be) with the aim of recovering the treatment expenses. Under German law, a claim for damages based on ProdHaftG originally accruing to the insured person, transfers by operation of law (cessio legis) to the insurance carriers that settle the injured person’s medical fees, cf. Sec. 116 of the Social Code No. 5 (SGB V), amongst others.

According to a recent draft bill from the EU Commission, a novation of the 85/374/EEC is planned. The scope of liable parties is to be extended, including online sales platforms and fulfilment centres. More product categories will be subject to strict liability, including software where defects might arise from its “ability to continue to learn after deployment”, which might increase liability risks for AI-driven medical devices. Defendants will have to disclose evidence to plaintiffs, which is reminiscent of a discovery procedure.

Legal actions in civil law matters with a case value exceeding EUR5,000 will be heard by a District Court (Landgericht); minor matters valued below this threshold are assigned to County Courts (Amtsgerichte). Appeals (Berufung) against District Court judgments may be lodged to Higher Regional Courts (Oberlandesgerichte) as appellate courts. Further appeals (Revision) have to be, but rarely are, admitted by the Federal Supreme Court (Bundesgerichtshof), which only decides on relevant matters of law, not on the appreciation of facts.

In cross-border cases, the local jurisdiction of German courts is determined by the so-called Brussels I-a Regulation (EU) No 1215/2012. As a basic rule, persons or legal entities domiciled in Germany may be sued before German courts. Such German parties, if accused of having committed a tortious act, may also be sued before courts of another country where the harmful event (damage) occurred or may occur caused by the act of tort, delict or quasi-delict. The substantive law applicable to non-contractual disputes (German or foreign law) follows from the so-called Rome II Regulation (EC) No 864/2007. By default, the law of the country where the plaintiff (ie, a person/patient harmed by a defective product) has his/her habitual residence and where the product had been marketed governs a case. Otherwise, the law of the country where the damage occurred may apply as well.

Plaintiffs filing a legal action to a German court have to advance the applicable statutory court fees for the complaint to be served to defendant. Court fees are mathematically determined as a function of the case value. For instance, a case valued at EUR10,000 generates court fees in the amount of EUR798. The figure for a case worth EUR100,000 is EUR3,387 in court fees, and a case value of EUR1,000,000 equals court fees of EUR17,643. If a case is withdrawn or settled, two-thirds of the court fees will be waived and refunded to the plaintiff. If the plaintiff wins the case, the court fees have to be reimbursed by the defeated defendant, and vice versa. A partial award of claim corresponding to a partial dismissal triggers an accordingly proportionate distribution of the costs among the parties.

The same principles apply to attorney fees, which accrue separately. Regardless of whether outside counsel charges fees based on hourly rates or fixed budgets, the party losing a legal action has to reimburse outside counsel fees incurred by the winning party, but capped at an amount at the rates determined by the statutory attorney fee schedule. For example, an attorney who has represented a party in a first instance lawsuit before a District Court in a case valued at EUR100,000, including an oral hearing, has to charge statutory fees in the amount of EUR4,947 subject to reimbursement to the winning party.

Where authorities or regulators make enforceable decisions (administrative acts, see 3.2 Regulatory Enforcement Mechanisms) imposing obligations (eg, suspend marketing a product or operating a facility) or denying permits applied for, the subjects of those decisions may file an objection usually within a time window of one month. A failure to timely submit the objection causes the decision (administrative act) to become conclusively binding regardless of its possibly having been unlawfully or unjustly taken by the authority. Deadlines are often legally dead serious indeed.

If the authority rejects the objection, which usually occurs within a matter of weeks, the affected company may sue the authority before an administrative or social court. In most cases, neither the filed objection nor the legal action will suspend the enforceability of the authority’s decision or order (administrative act) which had been declared as immediately effective. However, a company facing substantial disadvantages or losses prompted by the authority’s decision or administrative act (eg, an order for an immediate product recall or close-down of a factory) may seek injunctive relief before an administrative court by filing a motion to suspend immediate effectiveness and enforceability. The court will decide such emergency cases in a fast-track procedure, in drastic cases within a matter of days.

Matters related to products may become contentious between competitors, eg, with one company suspecting another of marketing a product not in conformity with compulsory regulations (eg, MDR, AMG, Cosmetics Regulation, etc), eg, containing prohibited ingredients, being mislabelled or accompanied by misleading promotional claims, or lacking a required marketing authorisation. In such scenarios, a complainant (company A) may send a warning letter to its competitor (company B) believed to be in violation of product regulations, and demand from company B the signing of a cease and desist undertaking, breaches of which are subject to a contract penalty. If such is denied, company A may file a petition for a preliminary injunction order with a District Court. Such injunction may granted ex parte, ie, without an oral hearing, very swiftly, often within 72 hours or less. In less clear cases, the matter will be adjudicated subsequent to an oral hearing scheduled within two to three weeks upon filing.

As a flip side for the petitioner, such fast-track injunction procedures are available only within a time window of four to six weeks (depending on the court district) upon the complainant’s/petitioner’s gaining knowledge of the competitor’s alleged non-compliance. Thus, complainants have to act forthwith in order not to forfeit urgency, and may not shelve ascertained cases of competitor non-compliance only to leverage them in the future. If urgency has been forfeited, a legal action in the main proceedings remains available for six months upon gaining knowledge before becoming time limited.

Class actions comparable to the proceedings for which the legal system in the USA is known do not exist in Germany. Only in the sector of misguided consumer investments in the capital market has an approximate equivalent of US-style class actions been created. Another attempt to streamline litigation in serial damage or mass tort matters was made in 2018, introducing so-called model declaratory actions. Basically, recognised consumer protection organisations are conferred standing in court to pursue model proceedings on behalf of consumers who sustained the same kind of losses, injuries, impairments or damage, and who signed up to a register of interested parties. The outcome of the model proceedings may be invoked as a binding precedent predetermining the results of subsequent individual actions pursued by registered consumers. In part due to their complexity and a certain loss of control, model declaratory actions have never gained real traction. In reality, individual attorneys manage to collect a larger number of clients (consumers) alleging that they have been harmed by the same type of product, including individual legal actions filed in the name of each client. Some cases may then be pushed forward to factually serve as pilot cases, while the bulk of subsequent cases is stayed by the judges to await the pilots’ outcomes.

Whereas in contractual matters the parties may be bound by clauses committing them to first seek an amicable resolution of disputes within the framework of moderated procedures comparable to arbitration, in non-contractual contentious matters the parties may immediately sue each other in court. However, judges on the civil benches of District Courts usually take their mandate to always explore options for a settlement (Sec. 278(1) Rules of Civil Procedure – ZPO) seriously. The parties may have explained to them their specific risks of not succeeding, or facing defeat, which arise from any escalation of the case, so that “battle-wary” parties may eventually seek a settlement. Settlements are recorded by the judge and may be enforced in the same way as judgments.

There are some binding precedent effects of administrative on civil law proceedings. But essentially, litigation between companies and consumers, proceedings against authorities and criminal investigations or sanctions imposed for infractions each follow different and distinct sets of rules, and serve different purposes. Thus, the level of interrelation is limited. Proceedings are not joined, so that legal protection and access to a fair trial are preserved to the widest extent.

See 5.2 Legislative Reform.

On the international scale, in recent years Germany has substantially caught up in laying the legislative foundations for accelerating the digitalisation of healthcare. A considerable number of parliament Acts and other legislative and executive instruments have been adopted to complete the regulatory framework fostering the rollout of e-prescriptions, telemedicine, electronic health records and access to health data for secondary use. Most recently, the Health Data Utilisation Act (Gesundheitsdaten-Nutzungsgesetz – GDNG) entered into force, promoting (and pre-empting to some extent) the intended facilitation of universal health data access envisaged by the draft European Health Data Space (EHDS) Regulation.

Legislative reform in the medical devices arena remains a prerogative of the EU legislators. Germany, represented by its leading med-dev industry associations, is spearheading MDR/IVDR reform efforts, foremost: a fast-track CE-certification procedure for devices indicated for orphan diseases and highly innovative products, cancelling the expiry of Notified Body certificates after five years which currently prompts re-recertification cycles that draw heavily on scarce resources, shifting recertification towards a risk-based concept allowing for broader utilisation of post-market data, working towards (revitalised) mutual recognition agreements with Switzerland and the UK, and creating access to effective judicial review of Notified Body decisions.

In the pharma sector, EU-driven legislative reform is on the horizon, too. The so-called EU pharma package to completely overhaul the set of Regulations and Directives is still in the pipeline of EU lawmakers. A redesign of regulatory data protection (and thereby market exclusivity) is proposed, abandoning the current 8 + 2 + 1 years formula in favour of a more complex 6 + 2 + 1 + 3 years scheme. This proposal has encountered opposition driven by concern that incentives for the costly development and launch of highly innovative medical products would be scaled back excessively. Further elements of the draft legislation include an expansion of environmental risk assessment affecting both newly authorised drugs and products already on the market, and putting anti-microbial drugs in general under the prescription-only status. Moreover, tighter advertising restrictions have been proposed, eg, a comparative advertisement may be banned if it highlights the inferiority of a specific drug or if it is based on study results not included in the SmPC. Enactment of the proposals is still awaited.

In Germany, as in all of the EU, the AI Act will have a strong impact on software-operated medical devices using AI features. Since medical devices are categorised as high-risk AI systems, manufacturers have to comply with a number of additional regulatory obligations extending and altering the responsibilities already set forth by MDR. The compulsory risk management system has to specifically address AI-related risks. The scope of the technical documentation will be expanded, special records are to be kept, and so-called deployers (ie, users) of AI systems will have to be adequately instructed, implying a broad spectrum of detailed information to be shared. The requirement to ensure constant human oversight includes a feature described as the ability to intervene in the operation of an AI-operated medical device including its interruption through a stop button. Such a feature may not always be realistically implementable. It may counteract the intended purpose of AI systems when the rapidity or continuity of machine-supported decision-making (eg, in the ICU, when operating life-supporting machines) is not compatible with human interference. The separate conformity assessment procedure prescribed for AI systems under the AI Act should be integrated in the CAP under MDR/IVDR, so that the Notified Body will perform a single audit and inspect the AI-related elements of the QM system and the TD jointly with the content and processes reflective of MDR or IVDR.