The United Kingdom left the European Union in the initial months of 2020 and went under an 11-month transition period. On January 1, 2021, Brexit came into full force. Post-Brexit, there were many changes that the UK went through, especially in the area of Medical Devices and IVD products.
The UK MHRA, the regulator for medical devices in the UK, came up with new requirements for the non-UK manufacturers willing to sell or market their product in the UK. The UK MHRA made it mandatory for the device manufacturers to register their products with the MHRA irrespective of their device classes and provided a range of grace periods for different devices classes based on the risk factor. Here is what is new for the Device Product Non-UK manufacturers post-Brexit.
1. Identifying and Appointing a UK Responsible Person
The non-UK medical device manufacturers need to identify and appoint a UK Responsible Person (UKRP) who will register their devices with the MHRA and enable them to place their devices in the UK market. The UKRP can be any individual or entity that has a registered office in the UK. The importers or distributors who represent the manufacturer in the UK can also act as UKRP to register devices with the MHRA.
2. UK Notified Bodies to the UK Approved Bodies
The UK Notified Bodies have now become the UK Approved Bodies, and these are the compliance bodies that could issue the UKCA compliance mark for the device products. There are three (03) main UK Approved Bodies available to provide conformity assessments and issue UKCA certification.
3. Device Markings
All the devices that will be marketed in Great Britain need to have a UKCA mark by July 1, 2023. The CE-marked products are valid in Great Britain only until June 30, 2023. The UKCA mark is voluntary for the devices from January 1, 2021. The MHRA accepts dual marking products in GB; however, the same is not valid in Europe and Northern Ireland. Further, the CE mark or the UKNI mark will be valid, and the UKCA mark won’t be valid in Northern Ireland.
4. DORS is Replaced
The MHRA online registration portal (DORS) is outdated and is now replaced with a new MHRA device portal. Any manufacturer registered on DORS has to move their applications to this new version of device registration and resubmit the applications. The device manufacturers who registered their devices on the DORS have to re-register their devices on the new MHRA Online Registration System to stay compliant and sell their devices on the UK market.
5. The Bulk Upload Spreadsheet Updated
The bulk upload spreadsheet on the MHRA online portal used has been updated to a new version. If the older version of the spreadsheet is being used, then it’s possible that you may not be able to upload the spreadsheet in the UK MHRA portal. It is necessary for you to download the latest version of the bulk upload spreadsheet.
6. Scope of the UK Approved Bodies has been Defined
The UK Approved Bodies has just given out the list of the UK Approved Bodies, and its scope was not defined earlier. On July 30, 2021, the MHRA published the scope of the UK Approved Bodies specific to the type of Products for each UK Approved Body. This has made it easier for the general public to know the scope of each Approved Body.
7. The MHRA Portal Bulk Upload Templates Changed
From August 20, 2021, 5 PM GMT, the MHRA portal bulk upload template was updated, and the earlier template was invalid after 5 PM GMT. Any templates downloaded and saved earlier were not used for bulk uploads as the same was not accepted from August 21, 2021. Starting from August 21, 2021, the device manufacturers or importers or UKRP have been using the new bulk upload templates. Any data created on or before August 20, 2021, and wasn't uploaded had to be transferred to new templates.
8. Video Tutorials Update
From August 24, 2021, the UK MHRA updated the video tutorials for using the MHRA portal and information on the UK MHRA website. These video tutorials give you an overview of how to use the UK MHRA’s Device Registration and Certificates of Free Sale (CFS) System. Before submitting payment for New Device and Device/Manufacturer registration applications, the Review page was also enhanced, and new functionality is available now.
More regulations are coming up from the UK MHRA. The Agency has also opened a consultation for the industry stakeholders to comment on the future of medical device regulations. For hassle-free registration of your devices with the UK MHRA or to appoint a UKRP, book a free 30-minute consultation meeting today with Freyr. Stay informed. Stay compliant.