EUROPEAN AUTHORISED REPRESENTATIVE

Europe is the second largest Medical device market, second only to the US and before countries like Japan, and Australia. This poses attractive opportunities for international companies trying to enter the European market. However, to be successful, it is essential that companies comply with and are able to meet local requirements and regulations.

European law requires companies marketing medical devices within the European union, to have a registered place of business in a Member State or to designate a person(s) responsible to act as a European Authorized Representative who is(are) established in the Community. The European Authorised Representative must inform the competent authorities of the Member State in which they have their registered place of business of the address of the registered place of business and the category of devices concerned.

The main activities of an authorized representative include:

Pre-market phase: Advising non-European manufacturers in the pre-market phase on EU market entry requirements including forming a regulatory strategy, clarifying and assisting with classification , meeting the essential requirements, and conformity assessment to achieve CE marking
Post-market Phase: Acting as the main point of contact with competent authorities and notified bodies

Due to possible conflict of interest with commercial objectives it may make sense not to use distributors as European Authorised Representatives.

Michor Consulting can help you carry out the responsibilities associated with and act as your European Authorized Representative:

Help with CE marking your device. This includes advice during the development phase, helping with the technical file(s) construction and/or review, clarifying the essential requirements, and product classification
Liaising and your primary contact with Competent Authorities and Notified Bodies
Keeping a copy of your technical file for local inspections
Register your device(s) with the national Competent Authorities before market entry
Vigilance reporting

In addition Michor consulting can provide high quality consultation on a wide range of regulatory compliance issues.