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

Posted April 17, 2018

Negotiators for the United Kingdom (U.K.) and the European Union (E.U.) have reached a draft Brexit agreement that has major implications for medical device companies. Although it provides some additional breathing room, it also leaves major questions up in the air.

The draft withdrawal agreement establishes 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.”

Another 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.”

If an agreement is not reached, then notified bodies located in the U.K. will no longer be able to conduct conformity assessments or affix CE markings, wrote law firm WilmerHale in a news alert. However, “most of the U.K.'s notified bodies are already implementing various strategies to accommodate medical device manufacturers in this transition, for example, by formally applying for designation as medical devices notified bodies in the [E.U.] or negotiating a retention of their capabilities and capacities as medical devices notified bodies in the U.K. after Brexit.”

The E.U. has in the past recognized notified bodies located outside of the union to certify medical devices, as is the case for Australia, Iceland, Liechtenstein, and Norway, the group noted, but it is too early to predict what the U.K.’s position will be.

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.”