AAMI News May 2018

Draft Brexit Agreement Provides Little Clarity for E.U. Device Manufacturers

A draft Brexit agreement has established a 21-month transition period, beginning on March 29, 2019, during which European Union (E.U.) laws and regulations would remain in effect in the United Kingdom (U.K.) even as the country formally leaves the union. This is significant as the date of application for the European Medical Device Regulation is scheduled for May 27, 2020, which falls during the transition period.

“This implies that this E.U. legislation will become U.K. law as well,” wrote Ronald Boumans, senior regulatory consultant at Emergo Group, a UL Company, in a blog post. “This will not work for the European Union In Vitro Diagnostics Regulation (IVDR) as that date of application is in 2022. However, I expect British lawmakers will ensure the IVDR will also be applicable.”

British businesses, including those in the technology sector, want to stick with E.U. rules after Brexit, according to data compiled by the Confederation of British Industry, citing the potential costs of losing access to Europe’s single market.

One area that remains unclear is the role of notified bodies during the 21-month transition period. According to the draft withdrawal agreement, “The United Kingdom shall ensure that, upon request by the certificate holder, information held by a conformity assessment body established in the United Kingdom in relation to its activities as a notified body under Union law before the end of the transition period is made available to a notified body established in a member state indicated by the certificate holder without delay.”

However, in the marked-up version of the draft agreement published on March 19, this section was one of a limited number of paragraphs that was not highlighted, indicating that “discussions are ongoing” and “no agreement has been reached.”

Although the outcome is far from certain, Boumans outlined the most favorable scenario for the medical device industry: Devices would retain free movement between the U.K. and the E.U., notified bodies would remain in place and be able to issue certificates, and the U.K.’s Medicines and Healthcare products Regulatory Agency would continue to exchange information with other competent authorities and the European Commission.

“But this ideal solution would come at a price: U.K. companies will have to accept the authority of the European Court when it comes to the interpretation of the law, without any negotiating power regarding those laws,” Boumans wrote. “This is not what the Brexiteers had envisaged, and therefore it will remain unclear exactly what will happen with medical devices after Brexit.”