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While the focus has been on COVID-19 the last few months, the United Kingdom is still intent on leaving the European Union. The 31^st December 2020 is creeping ever closer. From the very next day, all UK manufacturers who produce medical devices or in-vitro diagnostics from their sites in the UK will no longer have “direct” access to the European Union market.

 

For more information on an EU Authorised Representative, see our previous post.  

 

https://med-di-dia.com/news/brexit-making-headlines-again-what-is-the-impact-f

 

UK manufacturers will be treated as a third country under the EU rules. While some in the UK are wishing for a Christmas miracle in the form of a trade agreement, the signs are not looking hopeful. So, what do UK manufacturers have to do to be prepared for Brexit and keep their devices on the EU market?

Currently, under the Medical Device Directive (MDD), a manufacturer exporting their products from a country outside of the EU into any country in the EU, is required to have a legal agreement with an Authorised Representative (AR) who is a legal person based in the EU. The main duties of an authorised representative under the MDD, has been to act as a communication channel between the manufacturer and competent authorities such as the HPRA etc. Presently, any person can be designated an AR under the MDD as long as they are based in the EU.

 

In normal times prior to the introduction of the Medical Device Regulation, this would be sufficient but with the introduction of the new Regulations, a lot of EU AR’s have left the market due to the shared liability with manufacturers. While the AR is responsible for ensuring that the manufacturer is compliant, if this is not the case then the AR is equally liable as the manufacturer for any defective devices if the manufacturer has not met their obligations as per Article 10 of the MDR. Therefore, the role of an AR is not simply a placeholder but someone who must be active in ensuring that the manufacturer is fulfilling its obligations and that defective product is not placed on the market.

 

If your company is affected by Brexit or looking for access to the EU market, Med-Di-Dia are 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. 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