UK medical device MHRA registration explanation
From 1 January 2021, manufacturers preparing to place medical devices on the UK market must register with the MHRA.
From 1 January 2021, any medical device, IVD or custom device must be registered with the MHRA before it can be placed on the UK market. There is a certain grace period for the registration of the manufacturer, and different products have different grace period lengths:
From 1 May 2021, the following devices must be registered with MHRA:
1. Active Implantable Medical Devices
2. Class III medical devices
3. Class IIb Implantable Medical Devices
4. IVD List A Products
From 1 September 2021, the following devices must be registered with MHRA:
1. Class IIb non-implantable medical devices
2. Class IIa medical equipment
3. IVD List B Products
4. Self-test IVD
From 1 January 2021, the following devices must be registered with MHRA:
1. Class I medical devices
2. General in vitro diagnostic IVD
Note: Class I devices, LVDs, and custom devices that have been required to register with MHRA before 2021 will continue to be registered with MHRA on 1 January 2021;
Class I medical devices and general in vitro diagnostic LVD categories that were not previously required to be registered with MHRA must be registered with MHRA from January 1, 2021;
Products that were originally registered with MHRA through a UK authorised representative must update their registration information after 1 January 2021.
The manufacturer (or the UK responsible person) can register the product with MHRA before the grace period specified above
Consult I89273O8I27