On 11 January 2018, the European Commission has published a notice to companies to prepare for the withdrawal of the United Kingdom from the EU. As a concrete agreement has not been reached yet, the EC points out the consequences of the UK becoming a third country for EU product legislation – including medical devices.
The notice outlines especially the consequences for importers and distributors currently based in the UK as well as UK businesses. In addition, UK Notified Bodies will not be in a position to perform conformity assessment tasks pursuant to Union product legislation.
For the Medical Device Regulation (MDR), that means the issue of limited Notified Body capacity might be aggravated by the uncertain situation of UK based Notified Bodies after Brexit in 2019, directly impacting the ability of businesses to receive their CE certificates on time. You can read the full text of the European Commission notice here.