The UK’s exit from the European Union brought with it Britain’s withdrawal from the scope of application of the EU Technical Law, and consequently from the “CE Conformity System” (EEA). Our CEO Jörg Dogwiler summarises how this will affect approval of Swiss medical devices intended for the British market…
With the departure of the UK from the EU as of 31 January 2020 and the end of the transition period on 31 December 2020 came the UK’s withdrawal from the scope of application of the EU Technical Law and thus from the “CE Conformity System” (EEA).
Whilst there is a trade agreement between the EU and UK, it does not include mutual recognition of conformity assessments and equivalence of product regulations – there is no Mutual Recognition Agreement (MRA).
As such, the EU and UK have, in principle, become two different jurisdictions with differing product regulations. Whilst product regulations remain identical in these early post-Brexit days (which helps with products that can be tested and declared compliant by the manufacturer itself), over time, the requirements on either side of the Channel may begin to differ.
With the bilateral agreements no longer applicable in Britain, in terms of product approvals, the UK has now become a third country. Whilst Switzerland and the UK have shared a trade agreement since February 2019, mutual recognition was contractually secured for only three product categories (motor vehicles, good laboratory practice, good manufacturing practice for pharmaceuticals), because these categories are based on international standards.
For medical devices, and the other remaining 16 product categories which are regulated in the MRA CH-EU and are based on European standards, the lack of agreement on harmonisation of product regulations between the UK and EU meant that no agreement could be reached between the UK and Switzerland. Resulting, the requirements for placing a Swiss medical device on the Great Britain market have been affected.
How are devices currently regulated in Great Britain?
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)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
The directives above are given effect in UK law through the Medical Devices Regulations 2002. These Regulations (in the form in which they existed on 1 January 2021) continue to have effect in Great Britain.
This means that as of 1 January 2021, the “new” Great Britain route to market and marking requirements are still based on the requirements derived from current EU legislation.
What are the changes in requirements for placing a device on the British market?
As of 1 January 2021, a number of changes introduced through secondary legislation affect how medical devices can now be placed on the Great Britain market (England, Wales and Scotland).
Registration with the MHRA
Since 1 January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the market in Great Britain need to be registered with the MHRA. There is however a grace period for registering the below:
- Class IIIs and Class IIb implantables, all active implantable medical devices, and IVD List A products registered from 1 May 2021
- Other Class IIb and all Class IIa devices, IVD List B products and Self-Test IVDs registered from 1 September 2021
- Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) registered from 1 January 2022
Appointing a UK Responsible Person
Manufacturers based outside the UK wishing to place a device on the Great Britain market need to appoint a single UK Responsible Person who will take responsibility for the product in Great Britain. Requirements for appointing a UK Responsible Person to place devices on the Northern Ireland market are covered separately – find out more on this here.
Medical devices placed on the Great Britain market must have a UKCA mark (UK Conformity Assessed) or a CE marking, depending on which legislation the device has been certified under. Where relevant, the number of the Notified or Approved Body must also appear on the label.
If you already have a valid CE marking on your device, you are not required to re-label the device with a UKCA mark until 1 July 2023. Devices can have both marks present on the labelling prior to 1 July 2023, and dual marking will continue to be accepted on the Great Britain market after 1 July 2023.
However, the name and address of the UK Responsible Person, where applicable, does need to be included on product labelling where the UKCA mark has been affixed (including dual-marked devices).
To summarise, CE marking will continue to be recognised, and certificates issued by EU-recognised Notified Bodies will continue to be valid until 30 June 2023. But from 1 July 2023, a UKCA mark will be required to place a device on the Great Britain market. Where third party conformity assessment is required, a UK Approved Body is needed.
Post-market surveillance and vigilance
Once your medical device has been placed on the British market, as the manufacturer you are required to submit vigilance reports to the MHRA when certain incidents involving your device occur in Great Britain. You must also ensure your device meets appropriate standards of safety and performance for as long as it is in use, taking appropriate safety action as and when required. You can find more information on reporting adverse incidents and corrective actions to the MHRA here.