It’s been 42 months since the United Kingdom EU membership referendum took place, and with the date for ‘Brexit’ upon us it is time to reflect on upcoming changes.
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.
- UK Manufacturers or importers may no longer be considered economic operators in the EU after the end of the transition period. So, in order to place Medical Devices on the EU market, Manufacturers would need to be based in the EU, or contract with an Authorised Representative, Person Responsible for Regulatory Compliance (PRRC) and an importer based in the EU.
- Then moving forward, new CE certificates would only be issued by Notified Bodies based within the EU.
- Finally, in the event of a no-deal situation in December 2020, all certificates issued by UK-based Notified Bodies would become void in the EU.
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.
- EU manufacturers would need a ‘UK Responsible Person’ to take responsibility for their product in the UK, and register their product with the MHRA.
- The UK will mirror the key elements contained within Regulation 2017/745 (MDR) and 2017/746 (In Vitro Diagnostic Device Regulation, IVDR), via the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 when each is applied, the MDR on 26th May 2020 and the IVDR on 26 May 2022.
- After the transitional period, all medical devices (including active, implantable medical devices), In Vitro Diagnostic devices and custom-made devices will need to be registered with the MHRA prior to being placed on the UK market. The timelines for this are in line with the risk classification of the device and range from 4 months for high risk devices to 12 months for low risk ones.
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
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