Brexit and the regulatory situation for the medtech industry

31 January 2020 was a somewhat significant day as the UK formally left the EU at a strategic point in the implementation of the Medical Devices and IVD Regulations (EU) 2017/745 and 2017/746 (MDR and IVDR). At the moment, the situation for the medtech industry will stay seemingly unchanged from the regulatory position. But for how long?

From 1 February 2020, the UK moves into the withdrawal agreement period with the EU during which departure negotiations will take place and the MDR and IVDR will continue to apply. The withdrawal agreement continues until 31 December and because nothing is clear about its future trading agreements, it is hard to know what exactly will happen. 

Current common practice shows that daily business is not yet significantly affected

Current common practice shows that daily business is not yet significantly affected. For example, certificates issues by UK Notified Bodies will continue to be recognized and the requirements for extra-UK manufacturers to appoint a UK Responsible Person seems to be delayed as well. Nonetheless, EU medtech regulatory experts feel that the lack of official statements denotes uncertainty for medical devices companies worldwide and guidance from authorities about the circumstances, particularly about the roll-ever dates would be helpful for industry. 

On the whole, medtech experts are disappointed that the UK have left the EU and feel that it is a bad step for everyone in the middle of the largest regulatory changes for the medtech sector and that there will be a more onerous regulatory framework by having a split-up between the EU and the UK. 

Source: Medtech Insight (an Informa product)

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