Optimize your regulatory compliance and control with MedEnvoy as your EU Authorized Representative for medical device and IVD manufacturers.
Seamlessly Ensure Device Compliance with EU’s Leading Authorized Representative
Europe’s Leading Authorized Representative Provider
Why do you need a European Authorized Representative? If you are a medical device or IVD manufacturer without a registered office in the EU, you must appoint a local European Authorized Representative (EU AR/EAR) to meet the requirements of the EU MDR or IVDR. MedEnvoy provides this service. A European Authorized Representative may also be known as an EAR, EU AR, EC REP, CE REP, or EU REP.
Are You Looking to Transfer to a New EU Authorized Representative?
Whether you are dissatisfied with the support you are receiving, the price you are paying, or for some other reason, MedEnvoy has extensive experience supporting the transition from one EAR to MedEnvoy. MedEnvoy has developed a smooth process and successfully transitioned over 100 medical device and IVD manufacturers in the last 18 months alone.
From start to finish, we will manage your transfer from your current EAR to MedEnvoy. This includes preparing a tripartite agreement to facilitate the transfer in accordance with the MDR and IVDR transfer requirements and to ensure a smooth labeling transition that will make the switch cost-effective.
EU In-Country Representation for Medical Device and IVD Manufacturers
If you’re a manufacturer of medical devices or IVDs without a physical presence in the EU market where you intend to commercialize your products, designating an EU In-Country Representative, also known as an Authorized Representative (EUAR), is mandatory. Our EU In Country Representative Service is tailored to meet the specific regulatory needs of manufacturers looking to commercialize their medical devices or IVDs in the EU market.
As Your European Authorized Representative We Will:
- Perform a completeness review of your CE technical documentation and confirm that you have carried out an appropriate conformity assessment procedure
- Verify that the device labeling fulfills the requirements of the MDR/IVDR
- Keep a copy of the technical documentation at the disposal of the competent authorities to demonstrate the conformity of the device
- Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by the medical devices
- Inform the manufacturer about complaints or reports from healthcare professionals, patients, and users about suspected incidents related to the device
- Your selected EU AR must be identified on the device labeling!
Would you like to discuss with an expert or get a quote?
Augustus Bridge, Rotterdam
Frequently Asked Questions About Authorized Representation in the EU:
Regarding risks for non-EU manufacturers: from a market surveillance perspective the manufacturer can only place devices on the market under the MDR after they mandated a MDR AR; they will have to stop placing devices on the market after May 26 until there is a MDR mandated AR.