Based in London, Medical Device Consultants International Ltd. can serve as your European Authorized Representative. And we can tailor our services to meet your current and future needs.

Our staff will communicate with Competent Authorities and Notified Bodies, and is familiar with the regulations and additional national requirements for all countries throughout Europe, allowing you to be independent from an importer or distributor.

MDCI is a founding member of the European Association of Authorized Representatives (EAAR). As an EAAR member, MDCI maintains good relations with Competent Authorities, Notified Bodies and Trade Associations. You can be assured of receiving the highest level of expertise and professionalism.

As your European Authorized Representative, MDCI will:

Provide use of the MDCI Ltd. registered address

Help to ensure your compliance with the Medical Device Directives, the In Vitro Diagnostic Directive, and national transpositions

Represent you to Competent Authorities and Notified Bodies

Verify that your CE Mark is correctly affixed

Manage incident reporting to Competent Authorities with required follow-up

Initiate Conformity Assessment procedures and submit application to a Notified Body

Notify Competent Authorities of clinical trial

Click here to request our free guide which lists important points to consider when selecting your EU Authorized Representative.