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.
March 2, 2025
Approximately 5 minutes
Medical Device Registration in Germany: BfArM Notification and EU MDR Requirements
German Medical Device Registration: BfArM and National Requirements
Medical device market access in Germany is governed by the overarching European Union Medical Device Regulation (EU MDR 2017/745) and national legislation enforced by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (Federal Institute for Drugs and Medical Devices). Germany represents a major EU market, making national notification a critical step after obtaining the CE Mark.
1. Pre-Requisites for Market Placement
Before placing a device on the German market, manufacturers must satisfy all pan-European regulatory requirements:
- CE Marking: The device must bear the CE Mark, certifying its conformity with the EU MDR. For Class I non-sterile/non-measuring devices, this is self-declaration; for all other classes, it requires certification by an EU Notified Body.
- Authorized Representative (AR): Non-EU manufacturers must designate an EU Authorized Representative who is responsible for regulatory liaison, technical file maintenance, and communication with the BfArM on the manufacturer’s behalf.
- QMS Compliance: The manufacturer must maintain a Quality Management System compliant with ISO 13485 standards.
2. Mandatory BfArM Notification
All devices placed on the German market, regardless of classification, require a mandatory national notification to the BfArM.
- National Database Registration: While the final goal is central registration in EUDAMED, Germany currently requires registration with the BfArM's national system (or through the relevant EUDAMED modules once operational). This notification applies to all device classes, including Class I devices, and must include details of the manufacturer, the AR, and the devices themselves.
- Notification Scope: This process ensures the BfArM has oversight for market surveillance, vigilance, and corrective action implementation.
3. Language and Post-Market Obligations
Germany enforces strict national language requirements and robust post-market obligations:
- Language Requirements: All safety-critical documentation, including Instructions for Use (IFUs), labeling, and safety notices, must be provided in the German language.
- Vigilance Reporting: The AR is responsible for reporting serious adverse incidents occurring in Germany to the BfArM immediately.
- Post-Market Surveillance (PMS): Manufacturers must maintain a robust PMS system, gathering data on safety and performance, and submitting required Periodic Safety Update Reports (PSURs) as dictated by the EU MDR.
Related Articles
Approximately 5 minutes
The Two-Step Process: CE Marking and Mandatory BfArM Registration for German Market Access
To sell medical devices in Germany, manufacturers must first secure the **CE Mark** (Step 1) and then complete mandatory national registration with the **BfArM** (Step 2). This two-step process requires an **EU Authorized Representative** for non-EU companies and adherence to German language requirements.
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.