Authorised Representative

Your Professional EU Authorised Representative (EC REP) for MDR & IVDR Compliance

 

A reliable, expert presence in the European Union, dedicated to ensuring your medical devices remain compliant and your market access is secure.

For non-EU medical device manufacturers, appointing a European Authorised Representative (EC REP) is a legal prerequisite for placing products on the EU market. This is not just an administrative formality; it is a critical role that bears significant regulatory responsibility. Operating from our headquarters in Malta, Aequum provides a professional, reliable, and active EU representation service, acting as your trusted partner within the European Union.

We serve as the primary liaison between you and the EU Competent Authorities, managing all necessary interactions on your behalf. With our in-depth knowledge of the MDR and IVDR, we ensure your products and documentation are always in compliance, safeguarding your business from legal risks and ensuring smooth, uninterrupted market access.

Our Authorised Representative Services Include:

EU Representation and Competent Authority Liaison We act as your official legal presence within the EU, serving as the direct point of contact for all National Competent Authorities and other regulatory bodies. We manage official communications, handle requests for documentation, and support you in all vigilance and incident reporting procedures.

Pre-Market and Post-Market Regulatory Support Our support spans the entire product lifecycle. Before you enter the market, we review product labelling and Instructions for Use (IFU) for compliance. After launch, we provide ongoing post-market surveillance support, ensuring you remain compliant with all vigilance and safety reporting obligations required to keep your product on the market.

Product Safety and Compliance Verification As your EC REP, we meticulously verify that your technical documentation and Declaration of Conformity are correctly established and maintained. We conduct thorough compliance assessments to ensure every aspect of your product meets the stringent safety, quality, and performance standards of the MDR and IVDR.

Management of Technical Documentation and Device Registration We fulfill the legal obligation to hold a current copy of your technical documentation, ready to provide to competent authorities upon request. Furthermore, we assist in the registration of your devices and your company in the EUDAMED database, ensuring full transparency and compliance with EU-wide systems.

Choose Aequum as your EC REP and secure a vigilant, expert partner dedicated to safeguarding your European market presence.