Meet Evnia-AR our Authorised Representative operational branch, aimed to provide services in the field of EU-AR under MDR/IVDR. Relevant for all manufacturers outside EU, who seek Authorised Representative qualified in terms of European Regulations with extensive Technical Experience in the Medical Device Industry, do not hesitate to contact us!
Remember
- All manufacturers established in countries outside Europe (including the UK after Brexit) intending to place medical devices/in-vitro diagnostics in any Member State, should appoint an Authorised Representative (EC REP) with a physical address within one of the EU Member States (refer to Art. 11)
- The EC REP is not just a ‘post-box’ service. In fact, the EC REP should be an independent organisation acting in agreement with the manufacturer (ER mandate), and who is accountable (jointly with the Manufacturer) for any defective devices that enter the EU market.
EC REP Main Responsibilities
- Facilitate with PMS and support the Manufacturer with handling of complaint(s) and incident(s) reporting, as well as with product recalls and safety-related reports
- Keep a copy of all relevant documentation, to make available to the competent authority upon request
- Support Competent Authorities requests/audits by ensuring availability of product samples and/or information
- Ensure Manufacturer’s compliance with regulatory requirements by performing compliance checks
- Point of contact for EU Competent Authorities
How can Evnia-AR help?
Independently owned and operated, Evnia operates with the highest level of professional confidence and courtesy, eliminating all conflict of interests pertaining to confidential trade or product sensitive information.
Evnia-AR has an established team of Regulatory Specialists and other highly-qualified resources, enabling us to build trusted partnerships with Manufacturers throughout a device’s lifecycle.
EVNIA-AR shall provide companies with Authorized Representation services ensuring regulatory compliance, timely updates, realistic solutions and useful insights with respect to legal requirements.
Interested to know more?
Contact us today: info@evnia-ar.com
Read more: https://www.evnia-ar.com
