The UK Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on 31 December 2020, providing more information on the process to register medical devices and IVDs. The guidance also details the deadlines by which each class of product must be registered.
The Registration Process
As already published by the MHRA, the UK will continue to allow CE marked devices onto its market through 30 June 2023. After this date, manufacturers will need to undergo a UK Conformity Assessment (UK CA making) to continue selling in Great Britain (England, Scotland and Wales). Northern Ireland, the fourth UK country, will continue to require CE marking.
Whether a device has CE marking or UKCA marking, it must be registered with the MHRA. UK-based manufacturers will complete the registration directly. Manufacturers based outside the UK must complete the registration process through their UK Responsible Person (UK RP). The basic steps are as follows:
- The UK Responsible Person sets up a database account in the MHRA’s Device Online Registration System (MHRA DORS)
- UK RP registers the manufacturer in the database. They will provide the company name, address, contact person and a Letter of Designation that appoints the submitter as the UK RP for the manufacturer
- UK RP registers the device(s) and pays MHRA fee of £100 per registration – up to 100 device applications can be in a single registration
- The guidance details the information required for different product types, e.g., medical devices, custom-made devices, systems and procedure packs. Some key information required for all devices are:
- GMDN code
- Device name
- Model or version details
- EU notified body or UK Approved Body, as applicable,
- Device attributes, such as sterility
- The MHRA publishes basic registration information on Public Access Database for Medical Device Registration
- The registration must be renewed after one year, then every two years thereafter
The MHRA is providing a grace period for registration. However, these grace periods do not apply to devices under the first bullet below, and these products must be registered by 1 January 2021.
January 2021 – Class I Medical devices, IVDs and custom-made devices manufactured in the UK or where the AR is based in Northern Ireland
May 2021 – active implantable medical devices, Class III medical devices, Class IIb implantable medical devices and List A IVDs
September 2021 – Class IIb non-implantable medical devices, Class IIa medical devices, List B IVDs, and self-test IVDs
January 2022 - Class I medical devices and general IVDs no manufactured in the UK or where the AR is not based in Northern Ireland
While the registration process looks straight-forward, non-UK manufacturers should still focus on finding a UK representative and completing the registration process as soon as possible. If a product is not registered by its applicable deadline above, manufacturers cannot keep selling until the device has been registered.
Further, due to the size of the market, there may be a backlog with both UK RPs registering devices and with the MHRA’s overall review process. Therefore, in order to avoid any gap in sales, completing the above process sooner is in the manufacturers’ best interest.