The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance for manufacturers who intend to register to sell medical devices in the Great Britain (GB) and Northern Ireland (NI) markets after 01 January 2021.
In GB (England, Wales and Scotland), devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) so that they can be registered with the MHRA. The MHRA will only accept registration of devices from manufacturers or UK Responsible Persons that have a place of business in the UK, or from Authorised Representatives based in NI. MHRA is encouraging businesses to put a UK Responsible Person in place as soon as possible after 1 January.
Under existing regulations, the following devices will need to be registered with the MHRA after 01 January 2021:
- Class I medical devices
- Custom-made devices
All other classes of device placed on the GB market will require registration with the MHRA subject to grace periods over the following 12 months. The grace period will be dependent on the class of device.
Manufacturers will need to create accounts on the MHRA Device Online Registration System (DORS) before they can register devices. On DORS, they will need to share details of their operations and the device being registered, including which regulations it is subject to and attributes such as sterility, safety and efficacy.
The guidance also explains the situation for manufacturers that want to sell devices in NI, which will remain subject to EU regulation after Brexit. In some circumstances, manufacturers will need to inform the MHRA when they first place a device on the NI market.
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