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By Louise Place
What is known? At 11pm on Brexit day, Friday January 31st 2020 the UK formally leaves the EU and becomes a ‘third country’ (which means the UK will have the same status as countries like the USA and China), although EU law will continue to apply during the transition period as the UK and EU negotiate a trade deal. This transition period is planned to run until the end of December 2020. The outcome of negotiations is uncertain, it could be a deal that maintains the free flow of medical devices and diagnostics between UK and Europe, or the UK may remain a ‘third country’ and EU law ceases to apply.
So at the end of December there is a possibility that manufacturers who currently sell CE approved medical devices will fall into one of three categories; UK manufacturers selling into the UK, UK manufacturers selling into the EU, and EU manufacturers selling into the UK.
The first category is easy as UK manufacturers will have their product’s CE status transferred into UK law, so there will be no issues.
However, for UK manufacturers wishing to sell to the EU it might be more complex.
In the event of no deal in December 2020 there would also be an impact on European Manufacturers wishing to sell into the UK after the transition period.
With the implementation status of the Medical Devices Regulation in Europe not where anyone in the Industry would wish it to be, and only nine, or potentially eight (if there is no deal in December 2020) Notified Bodies designated against the MDR currently, it is clear that the industry as a whole is struggling to cope with the extent of the regulatory change.
The good news is it looks like the MHRA will take a pragmatic approach to the ‘worst-case’ no-deal scenario at the end of December 2020, whereby the European Regulations are transposed into UK Regulation so existing products do not immediately lose approval status; this goes a long way to maintaining access to vital products on the UK market and provides a clear pathway forward.
In the EU, UK manufacturers would be eligible to apply at national level for time-limited derogation for ‘protection of health’, but this is only likely to be granted for those devices with no alternative product for use in life threatening conditions, and is likely to be subjected to additional restrictions.
Here at Cambridge Design Partnership we’ll be keeping a close eye on the details of Brexit implementation and the impact on the healthcare sector. Next month we’ll be focussing on the implications of the changes to the Medical Device Regulation as the Date of Application approaches and how to be best prepared.
To find out how CDP can help you with the details of Brexit implementation and your MDR and IVDR transitions, please get in touch.
Head Of Regulatory Affairs and Senior Quality Assurance Consultant
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