Peter Brady, CEO at UK-based medical device software firm Ascensys Medical shares his thoughts on what the referendum outcome means for medical devices manufacturers
It’s hardly surprising that the results of the recent referendum continue to send shock waves throughout our country, the rest of Europe and the world.
Without becoming embroiled in the political arguments that look set to be thrashed out for quite some time, I’d like to explore what Brexit will mean for our medical devices community on a practical level.
How does Brexit impact medical devices regulation?
The Medical Devices Regulation (MDR) project is unlikely to be affected by Brexit and will likely come into force within the EU as planned and might even be introduced in the UK, certainly within the 2 years leading up to the deadline for exit.
As they come in to effect in the EU’s other member states, UK medical device manufacturers wishing to sell in this market will still need to comply with this regulation.
The UK is likely to aim for mutual recognition in negotiations with the EU and this will mean that European medical device regulation will apply to the UK. This still needs to be determined by the next government, however.
CE marks
Firstly, the EU treaty is unclear on what the next steps may be in terms of the legal framework as this is the first time a nation state has chosen to leave the EU. We do know that negotiations are due to start imminently. However, there remains a 2-year window before the deadline to exit.
It’s likely that the EU internal market (within which the medical devices market is situated) will be replaced with treaties.
The mutual recognition agreement that Switzerland has with the EU is likely to provide a close example of any future treaties between the UK and the EU.
In summary, the agreement between Switzerland and the EU allows for a mutual recognition of CE marks from notified bodies based in that country.
I wouldn’t anticipate that the UK would enter into an EEA membership and it is more probable that the position we will find ourselves in will be very similar to the agreement that exists between the EU and Switzerland.
The reason I wouldn’t expect an EEA membership to look likely is that we will be left with the implementation of EU law with no input or influence of a member state.
What will this mean for UK notified bodies?
The impact on UK notified bodies remains to be seen and will depend on the negotiated arrangements with the EU.
It’s most likely that the UK will retain one or more notified bodies but that will depend on whether we negotiate mutual recognition.
It's going to be an interesting ride...