Latest / Medical Device made Easy Podcast
What should you know on UKCA extension
Since Brexit happened, there are multiple waves of changes in the UK. First the UK Responsible Person (which is a hybrid of the EU AR and the EU Importer), then the UKCA requirements, then the new legislation consultation (which will largely harmonise UK law with the MDR and IVDR) and now the extension of the unilateral recognition of CE Marks to allow manufacturers more time to obtain a UKCA marks.
But what all this means for medical devices manufacturers that are already selling in the UK or that plan to sell to the UK. We will review that with Alex Denoon, partner at Bristows.
Don’t forget…
The skinny
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