Currently, the UK is a participant in the European regulatory network for medical devices, but after the end of the transition period, this participation will also end. The Medicines and Healthcare products Regulatory Agency will take on the responsibilities for the UK market undertaken through the European system.
But what will remain the same and what will change? The answers to these questions are below.
All devices that are in conformity with the applicable EU Directive will continue to be allowed until June 2023
No changes to the labeling of affected products will be required. Labels in English that includes information from other jurisdictions will be accepted.
Product may continue to carry a CE mark and devices that require conformity assessment by a Notified Body must have a valid CE certificate
On the exit day, a UK regulatory system will be available. All key elements which are included in the EU regulations will appear in it.
MDR and IVDR will not be “active” in the UK but both regulations will be accepted until the end of June 2023
A change in the role of the Notified Bodies will be in place
As of 1 January 2021, all medical devices placed on the UK market will need to have one of the acceptable marks – CE mark or the new UKCA. The type of the mark will only depend on which legislation the device has been certified under. If the medical device operator (manufacturer) has already a valid CE marking on the devices, no relabeling will be required until 1 July 2023 for placement on the Great Britain market.
From 1 January 2021, the information about “Name” and “Address” of the UK Responsible Person will need to be included on the product labeling where the UKCA mark has been affixed. *
From 1 January 2021, before being place on the UK market medical devices from all classes must be registered with the MHRA. The UK manufacturers must register, and the non-UK manufacturers must appoint a responsible person. Only for the new registrations, a grace period will be applied.
If the medical device is already registered in the MHRA, no re-registering will be needed. However, medical device manufacturers will be required to review the information held by MHRA.
*It is required only where applicable