Appointment of the European Authorised Representative (EU REP / EC REP)
For manufacturers established outside the European Union, the appointment of a European Authorised Representative (EC REP) is a mandatory requirement to ensure compliance with the regulatory obligations under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). This representative, who must be located within the EU, serves as the official point of contact between the manufacturer and EU regulatory authorities, facilitating communication and regulatory compliance.
Pharmilab can assume the role of European Authorised Representative (EC REP) on behalf of non-EU manufacturers, ensuring that their operations in the European Union are fully aligned with EU legislation. Our service guarantees not only compliance but also supports a smooth and effective entry into the EU market.
Our services include
European Authorised Representative
Acting as the European Authorised Representative for non-EU manufacturers, fulfilling all legal responsibilities under MDR/IVDR
Managing communication with EU regulatory authorities
Managing communication with EU regulatory authorities, including notifications, submissions, and any necessary interactions with competent authorities
Supporting the collection and submission of documentation required
Supporting the collection and submission of documentation required for conformity assessment and device registration
Managing incident reporting
Managing incident reporting and post-market surveillance (PMS/PMCF), ensuring continuous compliance throughout the product lifecycle
Supporting audits and inspections requested
Supporting audits and inspections requested by regulatory authorities
Ensuring compliance with all legal obligations
Ensuring compliance with all legal obligations, including EUDAMED device registration and maintenance of the Single Registration Number (SRN)
This service is essential for:
Non-EU manufacturers
Non-EU manufacturers seeking to place medical and in vitro diagnostic devices on the EU market and requiring an authorised representative to meet legal obligations
Communication with EU regulatory authorities
Companies wishing to streamline communication with EU regulatory authorities by outsourcing regulatory responsibilities to an expert partner
With our support, you can
Fulfil the EU representation requirement
Fulfil the EU representation requirement without establishing a physical presence in the EU
Ensure efficient and effective communication
Ensure efficient and effective communication with EU authorities and full compliance with all legal obligations
Facilitate market access
Facilitate market access with confidence that all MDR/IVDR requirements are fully met
