Basic Information on Medical Devices Regulation in Germany (BfArM Overview)

Regulatory Basis in Germany

Medical devices in Germany are regulated under the EU Medical Device Regulation (EU) 2017/745 (MDR), directly applicable since 26 May 2021, supplemented by national provisions in the Medical Devices Implementation Act (MPDG) and related ordinances. The Federal Institute for Drugs and Medical Devices (BfArM) acts as the higher federal authority responsible for market surveillance, vigilance, and certain administrative tasks for most medical devices (excluding in vitro diagnostics primarily handled by DIMDI/Paul-Ehrlich-Institut in specific cases). Basic information - BfArM

Scope and Definitions

Medical devices are defined per Article 2(1) MDR as any instrument, apparatus, appliance, software, material or other article intended by the manufacturer for human use for purposes including diagnosis, prevention, monitoring, treatment or alleviation of disease or injury, with the principal intended action not achieved by pharmacological, immunological or metabolic means.

• In vitro diagnostic medical devices fall under Regulation (EU) 2017/746 (IVDR).
• Products without medical purpose but listed in Annex XVI MDR (e.g., certain aesthetic devices) are also regulated.

Classification Rules

Devices are classified into risk classes I, IIa, IIb, and III based on Annex VIII MDR rules, considering intended purpose, invasiveness, duration of use, and potential risk. Higher classes require more stringent conformity assessment.

Conformity Assessment

• Class I (non-sterile, non-measuring): Manufacturer self-declaration.
• Higher classes: Involvement of notified bodies designated under MDR for quality system audit and/or technical documentation assessment.
• Certificates issued by notified bodies are entered in EUDAMED.

Market Surveillance and Vigilance

BfArM coordinates market surveillance in Germany:

• Monitors compliance through inspections, sample testing, and document reviews.
• Manages vigilance system for serious incidents and field safety corrective actions.
• Manufacturers must report incidents via EUDAMED Vigilance module and to BfArM.
• Coordinates with other EU authorities for cross-border issues.

Registration and Traceability

• Economic operators (manufacturers, authorised representatives, importers) must register in EUDAMED and obtain SRN.
• Unique Device Identification (UDI) required for traceability, with data uploaded to EUDAMED.
• Supply chain actors must maintain records enabling traceability.

Role of Notified Bodies

Notified bodies designated by ZLG (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten) and accredited perform conformity assessments. BfArM oversees designation and monitors their performance.

Practical Implications for Operators

• Manufacturers must ensure MDR compliance for new devices; transitional provisions apply to legacy MDD/AIMDD devices.
• Importers/distributors verify conformity documentation and UDI.
• Healthcare institutions report serious incidents to BfArM.
• BfArM provides guidance documents, FAQs, and participates in EU coordination groups.

This framework ensures high protection of health and safety for patients in Germany while facilitating the free movement of compliant medical devices within the EU. Basic information - BfArM