BSI UK Second Notified Body Designated Against EU IVD Regulation
There are now two notified bodies designated under the EU IVD Regulation and five under the Medical Device Regulation. But the latest notified body to be designated is a UK notified body, again raising concerns about designations and notified body operational capacity post-Brexit.
You may also be interested in...
The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.
The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.
The new EU MDR rules for economic operators are complex and burdensome for those not used to them. Chad Reynolds of RMQ+ outlines practical strategies for managing economic operators efficiently, and with a view to long-term compliance.