According to the Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR), an EU Authorised Representative (EU AR) needs to be designated by all medical device or in vitro diagnostic manufacturers based outside the EU that wish to sell their products in any of the Member States (MDR/IVDR Article 11).
What are the obligations of the Authorised Representative?
An EU AR should be placed in the EU (physical presence in one of the Member States) and will represent the Manufacturer in all interactions with the EU competent authorities, including device registration for new products. Additionally, according to MDR/IVDR Article 11.3, the EU Authorised Representative will:
Support the Manufacturer with complaint(s) handling and incident(s) reporting, as well as with product recalls and other post-market activities
Keep a copy of all relevant documentation, to make available to the competent authority upon request
Support Competent Authority requests/audits by ensuring availability of product samples and/or information
Ensure Manufacturer’s compliance with regulatory requirements by performing compliance checks
All responsibilities of the EU Authorised Representative are described in the EU AR’s Mandate (agreement document), that should be accepted in writing by both parties (Authorised Representative and Manufacturer). According to MDR/IVDR Article 11.2, the Mandate will be applicable for all Manufacturer’s devices of the same generic device group.
As per MDR/IVDR Article 11.5, the EU Authorised Representative is considered accountable (jointly with the Manufacturer) for any defective devices that enter the EU market.
What are the implications for a Manufacturer?
The Manufacturer should ensure the name, address and contact details of the Authorised Representative is listed in the device’s:
- product label,
- outer packaging and/or
- instructions for use.
How Evnia-AR helps?
Evnia-AR has an established team of Regulatory Specialists and other highly qualified resources, providing a trusted compliance partnership throughout your device’s lifecycle. EVNIA-AR shall provide companies with a trusted Authorised Representative that fulfils legal responsibilities and works in partnership with the Manufacturer to ensure regulatory compliance.
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