From 1 January 2021 a new regime will apply to medical devices placed on the market in the UK. New medical device regulations for the UK were published in 2019.

Those regulations essentially copy and paste the MDR and IVDR into UK law, albeit that this would be as a parallel system to that in the EU, unless mutual recognition is agreed. However new guidance from the MHRA suggests that these regulations might be repealed and replaced by an entirely new regulatory regime unique to the UK. A consultation in “autumn” is promised, but time is running short.

In the interim, the most recent MHRA guidance informs us of a new regime for the UK which treats Northern Ireland differently from Great Britain (England, Scotland and Wales). This is necessary because of the terms of the Northern Ireland Protocol agreed with the EU. That protocol avoids separating the island of Ireland along the border between the Republic of Ireland and Northern Ireland. This brings added complexity for medical device manufacturers because of different labelling requirements in Great Britain and Northern Ireland.

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