Laws and Ordinances Governing Medical Devices in Germany

Primary EU Regulation

The core legal framework for medical devices in Germany is Regulation (EU) 2017/745 on medical devices (MDR), which has been directly applicable since 26 May 2021, replacing the previous Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). The MDR establishes uniform rules across the EU for the design, manufacture, placing on the market, and post-market surveillance of medical devices. Laws and ordinances - BfArM

National Implementing Legislation

Germany has implemented the MDR through national laws and ordinances to address administrative procedures, competencies, and specific national requirements:

Medical Devices Implementation Act (MPDG)

• The Medizinprodukte-Durchführungsgesetz (MPDG) transposes provisions requiring national legislation and designates competent authorities.
• It defines responsibilities of federal and state authorities, including BfArM as the higher federal authority for most devices.
• Regulates notification obligations, market surveillance powers, and penalties for non-compliance.

Medical Devices Ordinance (MPDV)

• The Medizinprodukte-Verordnung (MPDV) contains detailed rules on administrative procedures, such as registration, notifications, and fees.
• Covers aspects like designation and monitoring of notified bodies, clinical investigations, and vigilance reporting channels.

Related Ordinances and Acts

• In Vitro Diagnostic Regulation (IVDR): Regulation (EU) 2017/746 applies directly for IVDs, with national implementation via MPDG and related provisions.
• MPBetreibV (Medical Devices Operator Ordinance): Regulates operation, maintenance, and reprocessing of devices by users (e.g., hospitals).
• MPKostV (Medical Devices Cost Ordinance): Sets fees for administrative acts by authorities.
• EU Implementing and Delegated Acts: Numerous Commission Implementing Regulations (e.g., on UDI, EUDAMED, vigilance) and Delegated Acts are directly applicable.

Key Obligations and Competent Authorities

• BfArM: Higher federal authority for market surveillance, vigilance coordination (except certain IVDs), designation of notified bodies (together with ZLG), and administrative tasks.
• State authorities: Conduct on-site inspections and initial market surveillance measures.
• Notified bodies: Designated under MDR perform conformity assessments for higher-risk classes.
• Manufacturers, authorised representatives, importers, and distributors must comply with registration in EUDAMED, UDI requirements, vigilance reporting, and supply chain traceability.

Transitional Provisions

Legacy devices (MDD/AIMDD certified) may continue to be placed on the market under extended transitional periods (e.g., until 2027/2028 depending on class and certificate date) if specific conditions are met, including application to a notified body by required deadlines.

Practical Guidance

BfArM provides detailed information on applicable laws, FAQs, guidance documents, and links to EU resources to assist manufacturers, operators, and users in complying with the MDR framework in Germany. Compliance with these laws and ordinances ensures patient safety and free movement of devices within the EU single market. Laws and ordinances - BfArM