EU Authorised Representative Service - Regulation (EU) 2017/745 (MDR) & (EU) 2017/746 (IVDR)
(EUAR / EC Rep / EU Rep)
Advena’s EU Authorised Representative Service meets the obligations of EU Regulations (EU) 2017/745 & (EU) 2017/746 and associated EU guidelines published by the EU Commission, to provide professional advice and vital regulatory news updates.
We support the European Commission’s Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Device Regulation (EU) 2017/746 requirement for non-EU based manufacturers to allow them to designate Advena as their single Authorised Representative within the European community.
The following are provided as part of the annual fee:
- An EU Authorised Representative service that complies with Regulation (EU) 2017/745 (The MDR) & (EU) 2017/746 (The IVDR).
- Specifically, the obligations as set-out in Article 11 of both Regulation (EU) 2017/745 (The MDR) & (EU) 2017/746 (The IVDR).
- A contractual agreement or Mandate followed by a Certificate of Designation for each year of service.
- Preparing Registrations for Class I and IVD device manufacturers with the Maltese Competent Authority. And the provision of registration certificates.
- Obtaining Certificates of Free Sales for contracted clients.
As required by EU Regulation, Advena employ qualified individuals who possess the necessary expert knowledge on regulatory requirements for medical devices. This knowledge is supported by academic qualifications and professional experience in regulatory affairs and quality management relating to medical devices.
This service has been developed over many years to specifically support the needs of small and medium-sized manufacturers and distributors.
Clients also receive regulatory news reports by email which we understand have been regarded as an invaluable means to keep up-to-date with the ever-changing regulations and standards.