“Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.”
For manufacturers of medical devices who can be accurately described by the above, it is a legal requirement to appoint an EU Authorised Representative.
An EU Authorised Representative may also be known as a EUAR, EC REP, CE REP, EU REP and also an EAR. All of these mean the same; EU Authorised Representative.
Your EU Authorised Representative (EC REP) provides a point of contact between you (the non-European medical device manufacturer) the national Competent Authorities (Ministry of Health) and Notified Bodies.
In addition, as your EC REP, Advena will:
- Operate in accordance to with EU Commission guidance
- Carry out applicable device registration with the Maltese Competent Authority, while EUDAMED is not fully functional
- Carry out its obligations as set-out in Article 11 of both Regulation (EU) 2017/745 (The MDR) & (EU) 2017/746 (The IVDR)
- Keep on file a copy of your full technical documentation for inspection by EU regulators, upon request.
- Provide assistance with vigilance and help you understand your obligations concerning reporting in accordance with the EU Regulations
- Provide regulatory news and updates via our free, monthly client newsletter.
Under the MDR (EU) 2017/745 and IVDR (EU) 2017/746, Authorised Representatives (EC REP) have greater responsibilities and take on significantly more risk and liabilities, therefore you can expect your representative to scrutinise your documentation more thoroughly. For more information regarding MDR or IVDR ‘click here’.
