Authorised Representative

Your Dedicated EU Representation

Non-EU medical device manufacturers are required by EU law to appoint an Authorised Representative (EC REP) to ensure product compliance. We are here to serve as your reliable EU-based representative, managing all necessary interactions with regulatory bodies and authorities on your behalf. With our experience and in-depth regulatory knowledge, we ensure that your products comply with European standards, safeguarding your business from legal and financial risks.

Our services include document reviews, product labelling checks, and acting as your point of contact with EU Competent Authorities. We focus on compliance with the MDR and IVDR, ensuring smooth and secure access to the EU market.

What we offer: