News New medtech regulations Notified Bodies

First Notified Body (BSI UK) is notified under the MDR

On 21 January 2019, the very first notified body (BSI United Kingdom) was officially notified in the European Commission database NANDO under the new Medical Devices Regulation.

Posted on 30.01.2019

On 21 January 2019, the very first notified body (BSI United Kingdom) was officially notified in the European Commission database NANDO under the new Medical Devices Regulation. We understand that BSI’s designation procedures under the IVDR in the UK, as well as MDR/IVDR in the Netherlands are still ongoing.

While it is positive to see that this development happened a good 6 months earlier than originally expected, in the context of a potential hard-Brexit it is important for the medtech industry that a deal addressing the status of all UK NBs is urgently agreed on.

The European Commission recently publicly stated that 39 NB applications have been received and 21 joint assessments have been performed. MedTech Europe is hopeful that more notification decisions will follow soon, for both Regulations. We look forward to the first NB being notified under IVDR as soon as possible as well.