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