How to maintain or introduce your Medical Devices on the UK market?
Following BREXIT, from 1 January 2021 the United Kingdom is no longer a member of the European Union. All medical devices, IVDs and custom-made devices must be registered with the MHRA (UK health authority) before being placed on the Great Britain market.
This applies to medical devices of all classes. In Great Britain (England, Wales and Scotland), devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA. Given that this is an extension of existing registration requirements, there is a grace period to allow time for compliance with the new registration process. Medical devices must be registered within the timelines set out below.
Great Britain medical device classification timeline:
The following devices must be registered with the MHRA if the devices are to be placed on the Great Britain market from 1 May 2021:
- Active implantable medical devices
- Class III medical devices
- Class IIb implantable medical devices
- IVD List A products
The following devices must be registered with the MHRA if the devices are to be placed on the Great Britain market from 1 September 2021:
- Class IIb non-implantable medical devices
- Class IIa medical devices
- IVD List B products
- Self-test IVDs
The following devices must be registered with the MHRA if the devices are to be placed on the Great Britain market from 1 January 2022:
- Class I medical devices
- General IVDs
Manufacturers of Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register its devices with the MHRA (i.e. where the manufacturer is based in the UK or the Authorised Representative is based in Northern Ireland), must continue to register its devices on the same basis as it did previously as the above registration timings will not apply to these devices.
The guidance specifies that under the new relationship, the representative in the UK will be termed the “UK Responsible Person” (UKRP). A UKRP must be appointed from January 1, 2021, and the UKRP must register the manufacturer, any relevant importers, and the devices with the MHRA. The MHRA plans to eventually replace the CE mark with a UK Conformity Assessment (UKCA) mark; its use is currently expected to become mandatory on June 30, 2023.
Keep in mind that
- EU-based manufacturers distributing their devices in the remaining Member States (EU27) will require a UK Responsible Person to distribute their devices in the UK.
- Non-EU manufacturers using an EU27-based AR will require a UK Responsible Person to distribute their devices in the UK. Non-EU manufacturers using a UK-based authorized representative (AR) will need to appoint a new EU27-based AR (and retain their existing UK representative as the UK Responsible Person).
- UK-based manufacturers will become non-EU manufacturers, who will need to appoint an EU-27 based AR if they want to place devices on the Union market.
UK - Class I device manufacturers
Manufacturers of Class I medical devices and general IVDs can self-declare its conformity against the EU MDD or EU IVDD as transposed by the UK MDR 2002 (as amended), before affixing a UKCA mark and placing the device on the Great Britain market.
Class I medical devices that are sterile or have a measuring function require approval from a UK Approved Body in order to be affixed with the UKCA mark and placed on the Great Britain market.