The European Authorised Representative/EC Rep is vital in the CE Marking of medical and in-vitro diagnostic devices under current MDR and IVDR regulation. Based in any non-EU countries and if you don’t have one, you won’t sell your goods within the EU. We can help you comprehend the responsibilities that go along with them.
At all times, we promise the most significant degree of professional confidence and civility. This is stated in our regular service contract or, if you desire it, in a specific confidentiality agreement signed with you.
Non-European manufactures will not be contacted directly by European Authorised Representative. Your European authorised representative or so-called EU rep will be the point of contact for all communications involved during registration, import alert, vigilance etc.
Your European Authorised Representative name and address must appear on your labelling, packaging, directions for use and, importantly, the technical file. Consequently, when various parties from all across Europe have issues or inquiries about your devices, they will contact us. It means we’ll be in continual contact with your distributors, end-users, consumers, and other stakeholders.