Common questions regarding EU Authorized Representation for medical device and IVD companies
What is the role of the Authorized Representative under the MDR and IVDR?
Authorized Representatives take on more risk and liability under Europe's Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR). The EC REP will be held jointly and severally liable for defective medical devices or IVDs, so you can expect that your representative will monitor your compliance more thoroughly. Download our white paper to learn more about the MDR changes.
How has Brexit affected representation requirements for device companies selling in the UK and the EU?
Following the UK’s departure from the European Union, EU and non-EU device companies must appoint a UK Responsible Person (UKRP) to continue selling in the UK. Further, UK-based companies need an EU-based AR to continue selling in the EU. Contact us to learn more about Brexit transition consulting services.
What happens if we do not appoint an EC REP?
Your Notified Body requires appointment of an EC REP before they will issue a CE certificate. Compliance to the MDR or IVDR is mandatory for any device placed in the EU market; therefore, engaging and identifying your chosen representative is essential. If you do not appoint a rep, your products may be stopped at the border.
Do we have to put the name of the Authorized Representative on our labeling, packaging and IFUs?
Yes. You must list the name and address of the Authorized Rep on the product label, outer packaging and/or Instructions for Use. The name and address of the Authorized Representative should be shown next to the official EC REP logo.
Can a Competent Authority inspect my Authorized Representative?
Yes. A Competent Authority can inspect an Authorized Representative at any time to determine if they understand their role, have direct access to client documentation such as the Technical File/Design Dossier and have processes in place to ensure it can fulfill its role as an Authorized Representative.
Can I change Authorized Representatives after I appoint one?
Yes. You may switch your EC REP without invalidating your product approvals in Europe. However, keep in mind that because your EC REP must be printed on your labeling, switching can be somewhat costly as you will need to change labeling and deal with the issue of products that are already on the market.
Additional services for Europe:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR compliance consulting for cosmetic and aesthetic products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies