The ripple effect of Brexit on medical device regulation

MHRA guidance for regulating medical devices in the UK from the end of the Brexit transition period (31st December 2020), published on 1st Sepember, makes it clear that we will all be navigating uncharted territory, but Northern Ireland could be the perfect location to wait out the storm.

With additional regulatory requirements that will continue to diverge over time and vary depending upon which market you wish to place your product; manufacturers will have to tackle an evolving regulatory landscape if they wish to place medical devices on either of the GB or NI markets.

What are the changes in each market?

For a medical device to be used in NI, it will still need to be CE-marked in compliance with current EU directives and incoming regulations (MDR and IVDR).  For GB, there will be the new UKCA mark, which will replace the CE-mark and will need to be on all devices by the 31st June 2023 and conformity assessed in accordance with whichever regulations the UK Government draw up before then.

So, what does this mean for medical device manufacturing?

It’s too early to assess the impact with any certainty but suffice to say, there is a huge risk of a regulatory logjam with devices being potentially rendered unusable until they are authorised through the new GB system.  The best advice is to plan early and for every eventuality with a close eye on any development from the UK Government.

NI as a potential manufacturing hub?

Brexit may prove lucrative for companies manufacturing medical devices in NI as devices manufactured here and bearing the CE mark can continue to be legally placed on the Great Britain (England, Scotland, Wales) market after the end of the transition period, as with all CE-marked devices that have been registered with the agency.

But the upside for NI comes at the end of the existing UK Medical Device Regulation transition (current legislation based on transposition of MDD, AIMD and IVDD) on 30 Jun 2023, when it appears that NI manufactured CE marked devices can continue to flow freely to the GB market. This is a huge incentive for medical device manufacturers to base their European operations in Northern Ireland for unfettered regulatory access to the GB and EU markets.  Whether this is viewed as a form of state aid by the European Commission that distorts the single market and/or breaches the Withdrawal Act signed by both sides in December 2019, remains a matter of ongoing debate and negotiations.

Where ARC can support

If all of this proceeds as planned by the UK Government, ARC is in the potentially unique position of being able to provide EC Rep services in NI and UK Authorised Responsible Person services for GB market access, as well as our core regulatory and clinical research support.  Finally our location, for now, plays to our favour!

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