For medical device manufacturers outside the EU, Authorized Representatives are crucial for navigating the complexities of the MDR and IVDR. Authorised representatives provide essential support for vigilance activities and play a key role in supporting CAPA processes. Authorised representative involvement strengthens compliance and communication, allowing manufacturers to focus more on innovation whilst maintaining the highest level of safety and performance.
Category - Authorized representative medical devices
Beyond Compliance: Transform Your Authorized Representative into a Strategic Partner
Authorised Representatives (EC-REP) can be strategic partners and not just a compliance necessity. A good EC-REP provides regulatory insights, strengthens supply chains, supports post-market activities, and offers access to expert networks. Therefore, choosing the right EC-REP is crucial for EU market success.
Lumis Is Launching a New Authorised Representative Service
Are you a non-EU medical device manufacturer? If so, Lumis could be your gateway into Europe via our new authorised representative service.
In accordance with Article 11 (1) of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), any manufacturer not established within an EU Member State must designate an Authorized Representative to market their devices within the EU.