Can I appoint my distributor as my EU Authorised Representative?
With the rush to ensure that UK based companies can continue to place their product on the market following Brexit, some companies may feel that the easy option is to appoint their distributor in an EU-27 country as their EU Authorised Representative (EU AR). There is nothing stopping manufacturers appointing their distributors in EU countries as their Authorised Representative prior to 26th May 2021 but from the date of introduction for the postponed Medical Device Regulation, the appointed EU AR must meet the minimum qualifications as per the MDR.
Appointing your distributor as your EU Authorised Representative may not be the best move. For one, the distributor will have access to all of your technical documentation for the products included in their mandate from May 2021. Another issue is that the distributor will appear on the products labelling from May 2021 alongside the EC Rep symbol which may strain relationships with other distributors. In some cases, some distributors may not be prepared to undertake the responsibilities of an EU Authorised Representative due to the shared liability for defective products between the EU Authorised Representative and the manufacturer.
If your company is affected by Brexit or looking for access to the EU market, Med-Di-Dia is willing to listen and support your products on the market. Med-Di-Dia is a regulatory and quality compliance consultancy firm supporting Medical Device, In-Vitro Diagnostic and Digital Healthcare companies from our base in Galway, Ireland and a full subsiduary of Global Regulatory Services. We offer a range of services under the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), including EU Authorised Representative, for companies placing their products on the European market from small start-ups to multinationals.
More information can be found at: https://med-di-dia.com/eu-authorised-representative.php