Appointing an Authorized Representative (AR) in Germany is a mandatory requirement under EU MDR 2017/745 for all medical device manufacturers based outside the European Union. Germany, being the largest medical device market in Europe, serves as a strategic entry point for market expansion—but only with proper regulatory representation in place.
A qualified Authorized Representative in Germany ensures seamless EUDAMED registration, ongoing regulatory compliance, and reliable post-market surveillance support.
What is an Authorized Representative?
An Authorized Representative (EC REP) is a legal entity established within the European Union, appointed by non-EU manufacturers to represent them before EU and national authorities. In Germany, this representative ensures compliance with EU MDR 2017/745 before medical devices are placed on the market.
Appoint a Trusted Authorized Representative in Germany
The Authorized Representative also acts as a liaison with German regulatory bodies, including the Federal Institute for Drugs and Medical Devices (BfArM).
Why Do You Need an Authorized Representative in Germany?
Appointing an Authorized Representative in Germany is not optional—it is a legal obligation under EU MDR. The AR plays a vital role in ensuring:
- Regulatory Compliance: Manages technical documentation, classification, CE marking, and conformity assessment procedures.
- Official Liaison with Authorities: Represents the manufacturer in communication with BfArM, EU Commission, and Notified Bodies.
- Product & EUDAMED Registration: Handles submissions to EUDAMED and oversees national registration processes in Germany.
- Post-Market Surveillance (PMS): Coordinates incident reporting, FSCA (Field Safety Corrective Actions), and complaint handling activities.
- Language & Labeling Compliance: Verifies German-language content for labels, instructions for use, and packaging to meet local requirements.
Key Requirements for an Authorized Representative in Germany
To legally operate as an Authorized Representative under EU MDR, the entity must:
- Be legally established in Germany or another EU Member State
- Possess in-depth knowledge of EU MDR 2017/745 and German regulatory standards
- Maintain regulatory documentation for a minimum of 10 to 15 years
- Handle vigilance reporting, audits, and product recalls
- Ensure all documentation, technical files, and CE marking are accurate and up-to-date
Responsibilities of an Authorized Representative Post-Approval
Even after your product is CE-marked and placed on the German market, your AR plays a vital role in ongoing compliance:
- Renewals & Amendments: Keeps documentation and certifications current
- Incident & Complaint Management: Coordinates with BfArM during adverse events
- Regulatory Updates: Notifies manufacturers of changes in EU/German regulations
- Audit Support: Represents the manufacturer during inspections and audits
How Operon Strategist Can Help?
Operon Strategist is a trusted regulatory consultant and Authorized Representative for medical device manufacturers aiming to enter the German and EU markets. We specialize in:
- Complete EU MDR 2017/745 compliance support
- EUDAMED registration & national authority liaison
- Regulatory document preparation and technical file review
- Post-market surveillance and vigilance reporting
- CE Marking, ISO 13485, and turnkey project consulting for medical device plants
Our team ensures your business expansion into the EU is compliant, fast, and smooth.
📩 Ready to enter the German medical device market?
Operon Strategist serves as a reliable Authorized Representative in Germany, helping manufacturers navigate complex EU regulations with confidence.
👉 Contact Operon Strategist to get started with regulatory representation and MDR compliance.