The UK government has released a proposed regime on the regulation of medical devices in Great Britain, Northern Ireland and the European Union post Brexit.
Under the guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to recognise CE marks and certificates issued by European Economic Area-based Notified Bodies until 30 June 2023.
From 1 July, companies will need the new UK Conformity Assessed (UKCA) mark to sell devices in England, Scotland and Wales. UKCA assessment bodies (CABs), will be designated by the MHRA in January.
The UKCA will not be recognised in the EU, EEA or Northern Ireland and products will still require a CE marking for sale in these markets.
All medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA from January 2021. There will be a grace period for registering:
- 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices
- 8 months for other Class IIb and all Class IIa devices
- 12 months for Class I devices
The 12-month grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA.
WHY IT MATTERS
The full impact on the medtech industry will be known after planned MHRA talks with the life sciences and healthcare sectors this Autumn. The Association of British HealthTech Industries and MedTech Europe had not responded to a MobiHealthNews request for comment at the time of publication.
THE LARGER CONTEXT
The UK has continued to be subject to EU rules under the terms of the transition period, which stops at the end of this year. From January 2021, England, Scotland and Wales are free to make their own regulatory regime.
Currently devices are regulated under Directive 90/385/EEC on active implantable medical devices (EU AIMDD), Directive 93/42/EEC on medical devices (EU MDD) and Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD).
These directives are given effect in UK law through the Medical Devices Regulations 2002 (UK MDR 2002) and will continue to have effect in Great Britain after the transition period.
The EU Medical Devices Regulation (MDR) and EU in vitro Diagnostic Medical Devices Regulation (IVDR) will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively. As these regulations will not take effect until after the transition period with the EU has ended, they will not automatically apply in Great Britain.
ON THE RECORD
The MHRA guidance says: “We have the opportunity to develop a robust, world-leading regulatory regime for medical devices that prioritises patient safety. We will take into consideration international standards and global harmonisation in the development of our future system.”