UK Conformity Assessment (UKCA) marking comes into effect

End of Brexit transition brings introduction of UK replacement for the CE mark for Great Britain

Following the end of the Brexit transition period, the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will not be transposed into law in Great Britain.  In this context, it is important to be aware of the distinction between Great Britain – England, Scotland and Wales – and the United Kingdom, which comprises Great Britain and Northern Ireland. The MDR and IVDR will not be implemented in England, Scotland and Wales. Northern Ireland will have a special status as EU rules will continue to apply there.

The Medical Devices Regulations 2002 (SI 2002 No 618, as amended) implement the Directives for active implantable medical devices, medical devices and in vitro diagnostic medical devices (IVDs) in the UK. These regulations continue to have effect in Great Britain. The UK regulations will be updated through the Medicines and Medical Devices Bill, which is currently working its way through the legislative process.

The UK Conformity Assessment (UKCA) mark is being introduced for certain goods being placed on the Great Britain market for which European CE marking applied. The UKCA mark will apply to medical devices, including IVDs, in Great Britain. The UKCA mark is not recognised in the EU or EEA.

Manufacturers of medical devices can use the UKCA mark voluntarily until 30 June 2023. The UK Medicines and Healthcare products Regulatory Agency (MHRA) will continue to recognize European CE marking until 30 June 2023. From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market. Manufacturers of Class I device and general IVDs can self-certify against the UKCA mark. Higher-risk medical devices and IVDs will require a UKCA certificate l from a UK Approved Body to affix the UKCA mark.

In addition to using the UKCA mark, manufacturers placing products on the market in Great Britain, need to appoint a UK Responsible Person and register with the MHRA. MHRA has published new guidance on registration requirements. MHRA will only accept device registrations from companies or UK Responsible Persons established in the UK or from Authorized Representatives based in Northern Ireland. An on-line system for registering devices has been set up (MHRA DORS). Registration requires information to be provided on the manufacturer, the device(s) and UK Responsible Person. The deadline for registration is:

• 1 January 2021 for manufacturers of Class I medical devices, IVDs and custom-made devices and that are either based in the UK or whose Authorized Representatives are based in Northern Ireland; 
• 1 May 2021 for active implantable medical devices, Class III medical devices, Class IIb implantable medical devices and IVD List A devices;
• 1 September 2021 for Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B devices, self-test IVD products;

• 1 January 2022 forClass I medical devices and general IVDs from manufacturers or Authorized Representatives are not based in the UK.

The Northern Ireland Protocol is a key part of the agreement on the UK withdrawal from the European Union. The effect of the Northern Ireland Protocol is that products on the Northern Ireland market, including medical devices, are required to comply with EU Regulations and Directives as well as with UK law. Separate requirements regarding CE marking will apply In Northern Ireland. Where CE marking requires the involvement of a notified body, certification must be done by an EU-based notified body. Under the Northern Ireland Protocol, any product moving from or through Great Britain to Northern Ireland is considered an import into the EU. As a result, a retailer or wholesaler may be considered an importer for Northern Ireland as opposed to a distributor of products.

Manufacturers should be aware of the changes affecting the UK market, keep up-to-date with the latest guidance from MHRA and UK Approved Bodies, and monitor developments in the forthcoming UK Medicines and Medical Devices Bill.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development