EU Authorized Representative
Why You Now Need an EU Authorised Representative
Regulations insist that to meet the requirements of the IVDR or EU MDR, if you are an IVD or medical device manufacturer and don’t have a registered office in the EU, you must appoint a local European Authorized Representative. The European Authoriszd Representative is also known as EU AR, EAR, EC REP, EU REP or CE REP.
Medenvoy’s primary role as your European Authorized Representative is to liaise between you and the authorities within the European Union and help you with any issues relating to post-market surveillance and vigilance.
MedEnvoy can act as your importer in the EU, UK and Switzerland!
European Authorised Representative Responsibilities
As your EU Authorized Representative, we perform many of the same responsibilities as a Swiss CH-REP. Shown below are some of our mandated legal obligations:
- Cooperate with the relevant authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by the medical devices
- Ensure the selected EU AR is identified on the medical device labelling
- Inform you, the manufacturer, about reports or complaints from healthcare professionals, users and patients about suspected incidents relating to the medical device
- Keep a copy of the relevant technical documentation at the competent regulatory authorities’ disposal to demonstrate the device’s conformity.
- Perform a completeness review of the CE technical documentation relating to your device and confirm that you have carried out the appropriate conformity assessment procedure
- Verify that the medical device labelling fulfils the requirement of the IVDR/MDR
How the EU Authorised Representative Process Works
MedEnvoy has developed a process that prevents duplication of efforts among your EU Authorised Representative and EU distributor(s). We utilize technology to ensure ongoing compliance with EU MDR or IVDR regulations.
For maximum efficiency, we will work with you to develop contractual arrangements and QMS procedures to prevent redundant activities from being performed while ensuring your compliance with EU MDR or IVDR regulations.
Responsibilities specific to you will be established and supported by procedures and work instructions that MedEnvoy will co-develop with you during our onboarding process. This will ensure speedy compliance checks and an uninterrupted flow of product shipments into the EU.
Have a subsidiary in the EU?
Manufacturers with an established legal entity in the EU can designate that entity as their Importer. MedEnvoy can provide “white label” back office services to your EU subsidiary to ensure all EU MDR/IVDR importer obligations are being met. Your subsidiary name goes on your labeling as importer!
Benefits of Selecting an EU Authorised Representative Process
- Your Importer must be identified on your product labelling. You maintain the flexibility to change distributors without reprinting all labelling.
- The importer must have permanent access to confidential technical documentation. We have no commercial interest in your devices, but distributors certainly do.
- Having one company act as your single Swiss, EU and UK importer will streamline the management of contracts, labelling, shipping and overall compliance for all devices sold throughout Europe.
In-country AR Fee structure
Our Authorized Representation services are provided for a flat annual fee, regardless of the number of devices.
- Technical File review fee (one time)
- Annual representation fee
NOTE: If you also work with MedEnvoy as your Importer, we can offer a multi-service discount.