EU Authorized Rep Service

If you are a medical device manufacturer based outside the EU, you must appoint a European Authorized Representative (EC REP) to legally place your products on the European market, as required by MDR Article 11. This role is more than just a formality—it’s a crucial compliance requirement that ensures your device meets all regulatory obligations. 

As your EC REP, we act as your official point of contact for European regulatory authorities and notified bodies. We ensure that your technical documentation is properly maintained, post-market surveillance requirements are met, and any incidents are reported in compliance with MDR regulations. With a deep understanding of the evolving regulatory landscape, we help you navigate the complexities of the European market with confidence.