Medicinal Products Registration

Article 14 (2) of the medical device directive states; “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.”

Therefore for manufacturers of medical devices who can be accurately described by the above, it is a legal requirement to appoint a European Authorised Representative.

A European 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 European 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 MEDDEV 2.5/10 Guideline for Authorised Representatives.
  • Carry out applicable device registration with the national Competent Authority.
  • Provide, if requested, a cursory regulatory review of your documents and product labelling.
  • Keep on file a copy of your full technical documentation for inspection by EU regulators, upon request.
  • Provide assistance with vigilance and Field Safety Corrective Actions (FSCA) reporting in accordance with MEDDEV 2.12/1 Rev 8.
  • Provide regulatory news and updates via our free, monthly client newsletter.

The name and address of the Authorised Representative must be included on your labelling, outer packaging or the instructions for use (IFU). You must also use the EC Rep symbol as designated in EN ISO 15223-1:2016.