Following Great Britain’s exit from the European Union, there have been a number of changes to how medical devices are placed in the Great Britain market, which includes England, Wales, and Scotland (but not Northern Ireland). Medical device manufacturers and distributors need to be aware of these changes and must take certain steps to ensure compliance with the changing requirements.
The following dates and regulatory changes are notable for medical device manufacturers and distributors operating in Great Britain:
- As of January 1, 2021, all medical devices placed on the Great Britain market were required to be registered with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). All grace periods for registering medical devices have since passed with the exception of Class I Medical Devices, custom-made devices, general in vitro diagnostic products (IVDs), and systems and procedure packs. Accordingly, all Class I Medical Devices must be registered with the MHRA by January 1, 2022.
- Medical device manufacturers based outside of the United Kingdom with no local presence are now required to appoint a United Kingdom Responsible Person (UKRP) who will take responsibility for the product in Great Britain. The UKRP is responsible for managing medical device registration as well as any relevant importer relationships and liaising with the MHRA on the manufacturer’s behalf.
- The European Union’s CE marking will continue to be recognized in Great Britain until June 30, 2023. On July 1, 2023, and thereafter, medical devices are required to be labeled with a United Kingdom Conformity Assessed (UKCA) mark. Notably, prior to July 1, 2023, manufacturers may use the UKCA mark on a voluntary basis, and medical devices can have both marks present on labeling. Dual marking will continue to be accepted after the July 1, 2023, deadline.
- Certificates issued by Notified Bodies recognized by the European Union will continue to be valid for the Great Britain market until June 30, 2023. The European Union will no longer recognize United Kingdom Notified Bodies.
- The name and address of the UKRP must be included on product labeling where the UKCA mark has been affixed. This includes instances where medical devices are dually marked.
To ensure compliance with these post-Brexit requirements, medical device manufacturers and distributors must ensure that the UKCA mark is affixed to all devices placed on the Great Britain market by July 1, 2023, as well as ensure that the name and address of the UKRP is included on the labeling. Additionally, manufacturers and distributors must ensure that a UKRP is appointed and that all medical devices are appropriately registered with the United Kingdom’s MHRA. Barclay Damon’s Health & Human Services Providers Team has experience assisting medical device manufacturers with compliance obligations as well as conducting due diligence relating to health care transactions involving medical device manufacturers, including those with an international presence.
If you have any questions regarding the content of this alert, please contact Brad Gallagher, partner, at bgallagher@barclaydamon.com; Jamie Dughi Hogenkamp, associate, at jhogenkamp@barclaydamon.com; Dena DeFazio, associate, at ddefazio@barclaydamon.com; or another member of the firm’s Health & Human Services Providers Team.