Executive Summary:
A company certified under the Medical Device Regulation (MDR) faced the challenge of establishing EU-authorised representation to comply with EU regulations for market entry. This included addressing customer inquiries, market authority communications, and creating compliant technical documentation for EU markets.
The Idea:
CEG’s primary idea to address the challenge was to leverage its MDR expertise and experience to act as the client’s EU-authorised representative. By staying updated on EU developments and requirements for authorised representation, CEG positioned itself as the ideal partner for ensuring compliance and facilitating market entry.
How did CEG help?
CEG maintained up-to-date knowledge of EU regulations and requirements for authorised representation, ensuring readiness to serve as the client’s representative. CEG provided comprehensive support to the client by leveraging its expertise in MDR compliance, handling customer inquiries and marketing authority communication.
Where are they now?
CEG’s intervention resulted in the client obtaining EUDAMED certification and successfully navigating three audits. This certification was approved annually, enabling the client to sell into countries with stringent MDR requirements, like Germany. Maintaining MDR status also made the client eligible for government subsidies and insurance from EU companies, further enhancing their market presence and credibility in the EU medical device market.
