On March 29, if there is a No Deal Brexit from the EU, how will currently CE Marked medical devices be regulated in the UK?
In an article written by Sofia Petkar and published by The Sun, a UK News Company, the No Deal Brexit is described as “A no-deal British departure from the European Union means leaving without formal arrangements for the future relationship.”
Common Questions about No Deal Brexit
The above quote raises many questions regarding the medical device industry worldwide, not just concerning Great Britain and the European Union.
- Would this mean that a no-deal exit would leave all of the British medical devices in an unregulated market?
- Would current EU regulations no longer apply?
- What about current EU approved devices, are they no longer approved for use in Britain?
- Is there now a doom and gloom scenario where care providers have to find bandages and gauze from underground back alley dealers in trench coats!?!?!?
- Would devices that normally need CE Marking now need to go through a separate process to be available in Britain? Would this apply to current CE Marked devices as well, or is there a grandfather period/clause?
- Will Britain now have its own separate vigilance and reporting standards?
- Basically will Britain have a compatible medical device regulatory system to the current European union one or will devices be regulated wholly independent of each other?
What the UK Department of Health says
If there is a No Deal Brexit, the UK would no longer be part of the EU regulatory network, and device manufacturers would need to submit medical device regulatory information directly to MHRA. The Uk’s Department of Health and Social Care updated their Guidance Document on January 3, 2019. The Guidance Document, How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal, summarizes what will happen to medical device regulations after March 29 if a deal is not reached.
The UK will recognize CE Marked medical devices, but formal UK presence at EU committees in respect of devices will cease. Should recognition of CE Marked devices change in future, adequate time will be provided for businesses to implement any changed new requirements. The UK will comply with all key elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulations (IVDR), which will apply in the EU from May 2020 and 2022 respectively. The ‘Implications’ section of the guidance document explains it in this manner:
“The EU (Withdrawal) Act will ensure that existing EU rules are converted into UK law at the moment of exit, with changes where necessary to make sure the rules work in the UK. Where this is needed, we’ll give adequate time for business to implement any new requirements. Additionally, where possible, we’ll be making use of the information we already have to complete administrative tasks for continuity of work and licences.
There are a number of changes where a UK approach will be required. Some of these are set out below. Other areas and further detail on some of the areas included here will be covered by consultation in the early autumn.”
As much as the guidance does not provide definitive answers about the future, the guidance confirms that CE Marked devices will also be permitted in the post-Brexit UK market. UK recognition of CE Marked devices could change in the future, but the promise is made to allow “adequate time will be provided” for any required implementation. UK compliance with the MDR, and the IVDR is also stated in the guidance. More good news in that this means that the UK medical device industry will remain somewhat stable for the near term.
Implications identified in the MHRA guidance
The following implications of a No Deal Brexit are explained briefly in the MHRA guidance:
- UK-based notified bodies will no longer be able to assess conformity of devices, and MHRA will no longer be able to assess those notified bodies.
- MHRA will continue to perform its own post-market surveillance of medical devices, but MHRA will be able to make its own decision over marketing of devices in the UK–regardless of EU decisions.
- Clinical studies conducted in the UK are managed nationally, and that will continue. However, MHRA is improving processes to enable closer relationships with ethics committees and allowing a single application and national decision.
- Although legal representatives may continue to be based in the EU or EEA, an individual in the UK will need to have overall responsibility for the trial.
Mutual Recognition Agreements, Decentralized Procedures and Centralized Procedures are all possible outcomes of the Brexit, but MRHA will publish more information in the coming months.