Germany Medical Device Registration
Important Notes
- National MPDG Implementation: After CE marking, manufacturers must submit German national registration (DIMDI registration) to BfArM or PEI per the German Medical Devices Act (MPDG).
- German Language Labeling & Info: All labels, IFUs, and information for healthcare professionals must be in German, with precise language compliant with DIN standards.
- Operator ID & Data Submission: Economic operators need an SRN from EUDAMED; product UDI-DI data must be submitted to the German central device database and linked to national insurance codes.
- Pricing & Early Benefit Assessment (EBA): Innovative high-risk medical devices and Digital Health Applications (DiGA) must undergo a strict Early Benefit Assessment by the Federal Joint Committee (G-BA) to prove added medical benefit before statutory health insurance reimbursement.
- Digital Health Applications (DiGA) Fast Track: Qualifying software as a medical device can obtain temporary reimbursement for one year via BfArM's DiGA fast-track, during which real-world evidence must be collected for continued access.
- Advertising & Professional Conduct: Promotion to healthcare professionals must follow self-regulatory codes (e.g., FSA) and be based on balanced scientific evidence.
Germany Specific Requirements
- Evidence-Based & Highly Legalistic: Regulatory processes are transparent, based on law and scientific evidence; G-BA benefit assessment is central to medical device market access and pricing.
- "Innovation-Friendly" Framework: Accelerated pathways and flexible evidence generation (e.g., for high-risk devices, DiGA) exist for breakthrough medical technologies, encouraging innovation.
- Statutory Health Insurance Dominance: Over 85% population covered by statutory insurance (GKV); inclusion in its reimbursement catalog is key for medical devices but faces strong cost-containment pressure.
- Specialized Distribution & Procurement: Hospital procurement led by purchasing groups; pharmacy channel controlled by large wholesalers; professional KOL engagement is critical for medical devices.
- Pursuit of Quality, Data & Sustainability: Extremely high demands for medical device quality, clinical data rigor, environmental standards (e.g., packaging recycling), and supply chain transparency.
Medical Devices Registration
Regulatory Requirements
- CE Marking Certification (according to MDR)
- Classification Management per MDR (Class I, IIa, IIb, III)
- Complete Technical Documentation (German/English)
- Clinical Evaluation Report (CER)
- Quality Management System (EN ISO 13485:2016)
- Post-Market Surveillance Plan (PMS)
- Vigilance System Documentation
- European Authorized Representative (EC Rep)
- UDI-DI Code Registration
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Notified Body Assessment
- Conformity Assessment Completion
- EUDAMED Registration
- CE Certificate Acquisition
Registration Timeline
12-24 months
Official Fees
€5,000 - €80,000
Service Fees
$25,000 - $80,000
Regulatory System Overview
BfArM
Federal Institute for Drugs and Medical Devices Germany
Responsible for medical device market surveillance, vigilance system management, clinical trial approvals. Operates as the primary medical device regulatory authority under the German Ministry of Health, coordinating regulatory activities across 16 federal states.
G-BA
Federal Joint Committee (Gemeinsamer Bundesausschuss)
The highest decision-making body in the German self-governing healthcare system, responsible for Early Benefit Assessment (EBA) of innovative high-risk medical devices and Digital Health Applications (DiGA) for statutory health insurance reimbursement.
PEI
Paul Ehrlich Institute
Federal Institute for Vaccines and Biomedicines, responsible for regulation of medical devices incorporating blood products, vaccines, gene therapy products, and tissue engineered products.
Medical Devices Registration Process
Product Classification Determination
Determine medical device risk classification according to EU MDR 2017/745 (Class I, IIa, IIb, III)
Technical Documentation Preparation
Prepare complete technical documentation including clinical evaluation report, risk management file, performance verification
Notified Body Assessment
Undergo technical documentation review and on-site audit by EU Notified Body
European Authorized Representative
Appoint authorized representative in Germany or EU for regulatory communications
EUDAMED Registration
Complete product and economic operator registration in EUDAMED database