As with any regulated international industry, Brexit and medical devices are closely intertwined.
Amidst the chaos of coronavirus, Brexit barely made the front pages until the government secured a withdrawal deal on Christmas Eve. Changes as a result of this deal have been enforced since the 1st of January, and Brexit is undoubtedly making an impact in the medical device world.
What does the future hold? We take a look at three major developments.
Brexit is set to change how medical devices are regulated in the UK.
In September 2020, the MHRA announced that the upcoming EU Medical Device Regulation (MDR) and its connected in vitro Diagnostics Medical Device Regulation (IVDR) won’t be transplanted into a post-EU Britain.
The regulations are set to come into force in May 2021 and 2022 across EU member states, and it was expected that an independent Britain could adopt them as a result of its longstanding regulatory alignment with Europe.
The MHRA has confirmed that won’t be the case, setting the stage for a Britain-specific regulatory update for the medical device world.
To create a ‘robust, world-leading regulatory regime for medical devices’, the government are in the process of working with stakeholders, and intend to follow these discussions with formal public consultations.
The MHRA gave a flavour of what its independent strategy will look like earlier in the year with the publication of its 2020-21 business plan. Three major shifts were emphasised:
- Increased focus on speed to market with a National Accelerated Licencing route and fast-tracked licencing procedures for biosimilar products set to go live in 2021
- Greater emphasis on post-market medical device surveillance as a counterbalance to this faster market entry, with CPRD data to be translated into a set of common data models and AI- and data-driven ‘lifecycle monitoring’ to be unveiled
- A ‘patient-first culture’ with increased engagement and transparency around treatment options
The MHRA also confirmed that three EU medical device directives will remain in force in 2021:
- Directive 90/385/EEC (active implantable)
- Directive 93/42/EEC (general medical devices)
- Directive 98/79/EEC (in vitro diagnostic)
The government have stated that these directives will continue to apply to Britain from the 1st of January 2021. British medical device manufacturers should therefore focus on remaining compliant with these regulations.
New conformity marking
CE marking remains in force in the UK until June 2023 if you provide medical devices to the British market – and will, of course, remain valid for Europe.
But the MHRA has unveiled its own conformity marking: UK Conformity Assessed, or UKCA.
From 2023, UKCA marking will be required for the supply of medical devices to England, Scotland and Wales, with Northern Ireland retaining CE marking accompanied by UK(NI) marking.
Typical elements from the CE marking process – design and manufacturing records, demonstration of conformity to requirements, a Declaration of Conformity containing product specifications – will be required for UKCA compliance.
UK Responsible Person
International medical device manufacturers serving the British market will need to designate a UK Responsible Person, with similar responsibilities to the Authorised Representative laid out in the MDR.
These responsibilities include:
- Ensuring application for the UKCA assessment process
- Maintaining and sharing with the MHRA any product/technical documentation and Declaration of Conformity
- A blending with an ‘importer’ role, making the RP responsible for placing the medical device into the British market
The government has set out its advice for appointing UK Responsible Persons. As this requirement came into effect from 1st of January 2021, EU medical device manufacturers should begin the process of training and assigning a suitable Responsible Person to serve the UK market as soon as possible if they have not already done so.
Now that the UK has officially left the European Union, there are undeniable changes to how medical devices are regulated and brought to market in the UK.
New legislation and conformity marking stand out as the major developments for a post-EU medical device operation, but it’s likely that at least some core elements of EU medical device compliance will remain valid and applicable in the UK going forward.
As Britain adopts to its new independence, Brexit and its implications on medical devices remain interlinked. Understanding which elements of your medical device operation will need to be amended and updated for continued compliance is a crucial priority for your organisation moving forward.