Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
Regulatory Compliance Associates Inc. (RCA)
Pleasant Prairie, WI, Tampa, FL
Regulatory Compliance Associates (RCA) is a leading global provider of regulatory and compliance expert consulting services for life science companies. The company offers expertise in regulatory affairs, assessments and audits, agency response, preparation and remediation, and new product development support for medical devices, pharmaceuticals, and compounding pharmacies.
April 2, 2025
Approximately 5 minutes
The Two-Step Process: CE Marking and Mandatory BfArM Registration for German Market Access
German Medical Device Registration: Two Key Regulatory Steps
Accessing the German medical device market requires a dual approach, combining the pan-European compliance of the EU Medical Device Regulation (EU MDR) with mandatory national notification governed by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).
Step 1: Achieving Pan-European Compliance (CE Mark)
The initial, and most critical, step is achieving the CE Marking. This allows the device to be legally placed on the market across the entire EU, including Germany.
- Device Classification: Determine the device class (I, IIa, IIb, III) according to MDR Annex VIII, as this dictates the required conformity assessment route.
- Technical Documentation: Assemble a comprehensive Technical File and Clinical Evaluation Report (CER) to demonstrate safety and performance.
- QMS Certification: Implement a Quality Management System, typically compliant with ISO 13485. For higher-risk classes (IIa, IIb, III), a Notified Body must audit and certify the QMS and the device file.
- EU Authorized Representative (AR): Non-EU manufacturers must appoint an EU AR to act as the legal point of contact within the EU.
Step 2: Mandatory National Registration (BfArM Notification)
Once the CE Mark is secured, national notification must be completed with the German competent authority, the BfArM.
- BfArM Notification: All devices, including self-declared Class I devices, must be notified to the BfArM. This is a crucial step for market surveillance and vigilance management in Germany.
- EUDAMED & National Portals: While the goal is central registration in EUDAMED, Germany maintains a national notification system for certain modules or relies on the BfArM interface to fulfill national oversight requirements during the EUDAMED transition phase.
- Required Information: The notification typically requires details regarding the manufacturer, the AR, the device classification, and the CE certificate (if applicable).
Key German-Specific Requirements
Manufacturers must also adhere to specific requirements enforced at the national level:
- Language: All safety-relevant information, including Labeling, Instructions for Use (IFUs), and safety warnings, must be provided in the German language.
- Vigilance: Serious incidents and Field Safety Corrective Actions (FSCAs) must be promptly reported to the BfArM by the AR.
Related Articles
Approximately 5 minutes
Medical Device Registration in Germany: BfArM Notification and EU MDR Requirements
Selling medical devices in Germany requires full compliance with the **EU MDR**, the presence of a **CE Mark**, and mandatory national notification with the **BfArM**. Non-EU manufacturers must designate an **EU Authorized Representative** and ensure all device documentation and labeling are provided in German.
Approximately 5 minutes
Registering Medical Devices with the BfArM: The National Notification Requirement
All medical devices sold in Germany, regardless of classification, require mandatory national notification with the **BfArM** (Federal Institute for Drugs and Medical Devices) after obtaining the **CE Mark**. This process ensures compliance with the **EU MDR** and facilitates national market surveillance. Non-EU manufacturers must use an **EU Authorized Representative**.
Approximately 5 minutes
Germany's Unique Regulatory Landscape: National Requirements Beyond EU MDR
Selling medical devices in Germany requires full **EU MDR compliance** and **CE Marking**, but also mandates additional national steps, including **BfArM notification**, enhanced **documentation standards**, and strict adherence to **German-language requirements** for all user and patient-facing materials.