Germany Product Registration & Certification
Important Notes
- National MPDG Implementation: After CE marking, manufacturers must submit German national registration (DIMDI registration) to BfArM (drugs & some devices) or PEI (IVDs) 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 (e.g., GMNNR).
- Pricing & Early Benefit Assessment (EBA): Drugs and some innovative high-risk devices (e.g., 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: Public drug advertising is heavily restricted; promotion to HCPs must follow self-regulatory codes (e.g., FSA) and be based on balanced scientific evidence.
Germanyecific Requirements
- Evidence-Based & Highly Legalistic: Regulatory processes are transparent, based on law and scientific evidence; G-BA benefit assessment is central to market access and pricing.
- "Innovation-Friendly" Framework: Accelerated pathways and flexible evidence generation (e.g., for ATMPs, DiGA) exist for breakthrough therapies, orphan drugs, and digital health, encouraging innovation.
- Statutory Health Insurance Dominance: Over 85% population covered by statutory insurance (GKV); inclusion in its reimbursement catalog is key 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.
- Pursuit of Quality, Data & Sustainability: Extremely high demands for product 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.
BVL
Federal Office of Consumer Protection and Food Safety Germany
Responsible for safety regulation, risk assessment, and market surveillance of food, food supplements, and cosmetics. Coordinates German food safety monitoring network.
Paul-Ehrlich-Institut
Paul Ehrlich Institute
Federal Institute for Vaccines and Biomedicines, responsible for regulation of blood products, vaccines, gene therapy products, tissue engineered products and other advanced therapy medicinal 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
Cosmetics Registration
Regulatory Requirements
- CPNP Notification (Cosmetic Products Notification Portal)
- Product Information File (PIF) German Version
- Cosmetic Product Safety Report (CPSR)
- Good Manufacturing Practice (GMP) Certification
- German Product Labeling
- Ingredient Safety Data
- Nanomaterial Notification (if applicable)
- CMR Substances Compliance Proof
Main Process
- Safety Assessment Completion
- Product Information File Preparation
- CPNP Notification Submission
- Labeling Compliance Review
- Market Surveillance Preparation
Registration Timeline
3-6 months
Official Fees
€0 - €5,000
Service Fees
$8,000 - $20,000
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.
BVL
Federal Office of Consumer Protection and Food Safety Germany
Responsible for safety regulation, risk assessment, and market surveillance of food, food supplements, and cosmetics. Coordinates German food safety monitoring network.
Paul-Ehrlich-Institut
Paul Ehrlich Institute
Federal Institute for Vaccines and Biomedicines, responsible for regulation of blood products, vaccines, gene therapy products, tissue engineered products and other advanced therapy medicinal products.
Cosmetics Registration Process
Safety Assessment
Complete cosmetic product safety report (CPSR) by qualified safety assessor
PIF Documentation Preparation
Prepare complete product information file including German version
CPNP Notification
Submit product information through EU Cosmetic Products Notification Portal
Labeling Compliance Review
Ensure labeling complies with German market specific requirements
GMP Compliance
Establish manufacturing system compliant with EU cosmetic GMP requirements
Food Supplements Registration
Regulatory Requirements
- German Food and Feed Code (LFGB) Compliance
- EU Food Regulation (EC) No 178/2002 Compliance
- Nutrition and Health Claims Compliance (EC) No 1924/2006
- German Product Labeling
- Ingredient Specifications and Purity Proof
- Heavy Metals and Contaminants Testing
- Microbiological Test Reports
- Allergen Information Declaration
Main Process
- Ingredient Compliance Assessment
- Technical Documentation Preparation
- Labeling Review Preparation
- HACCP System Establishment
- Traceability System Establishment
Registration Timeline
4-8 months
Official Fees
€1,000 - €10,000
Service Fees
$10,000 - $25,000
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.
BVL
Federal Office of Consumer Protection and Food Safety Germany
Responsible for safety regulation, risk assessment, and market surveillance of food, food supplements, and cosmetics. Coordinates German food safety monitoring network.
Paul-Ehrlich-Institut
Paul Ehrlich Institute
Federal Institute for Vaccines and Biomedicines, responsible for regulation of blood products, vaccines, gene therapy products, tissue engineered products and other advanced therapy medicinal products.
Food Supplements Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with German and EU permitted lists
Nutrition Claims Review
Review all nutrition and health claims for EU regulation compliance
Labeling Compliance Review
Ensure labeling fully complies with German LFGB and EU labeling regulations
HACCP System
Establish Hazard Analysis and Critical Control Points system
Traceability System
Establish complete supply chain traceability system