An early agreement has not been reached by Brexit negotiators on the role of notified bodies during the United Kingdom’s (UK) staged withdrawal from the European Union (EU). Negotiators are yet to make progress on the section of the draft withdrawal agreement concerning medical device certification groups.
EU and UK negotiators have released a marked-up version of the previously published draft document which aims to present the progress they have made. The majority of the document is now highlighted in green which indicates that negotiators have reached an agreement on the content and only technical legal revisions are required. The section of the draft document on notified bodies is not highlighted which shows that discussions are ongoing about the text proposed by the EU and that an agreement has not been reached.
The draft document discusses the activities of notified bodies during the intended 21-month Brexit transition period. During the transition period the UK will have officially left the EU but the UK hopes to retain some of the benefits of EU membership. During the transition the EU is proposing to place certain obligations on notified bodies on both sides of the divide during the transition.
The marked-up draft agreement states that the “UK shall ensure that, upon request by the certificate holder, information held by a conformity assessment body established in the UK 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”.
Although negotiators are yet to agree on the section regarding notified bodies, development in other areas may now enable negotiators to focus on the role of notified bodies. Sections that are relevant to drug and device regulation have been agreed. For example, upon a reasoned request from a Member State or the European Medicines Agency (EMA), the UK should make available without delay the marketing authorisation dossier of a medicinal product authorised by a competent authority of the UK before the end of the transition period.
To view the draft agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, please click here.