Regulatory Update: New Guidelines of UK MHRA
The UK MHRA published a new set of guidelines related to the UK medical device regulations starting from January 1st, 2021.
From January 1st 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator. The UK Responsible Person will act on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA . Any medical device, IVD or custom-made device will need to be registered with the MHRA before being placed on the Great Britain market.
Given that this is an extension of existing registration requirements, there will be a grace period to allow time for compliance with the new registration process.
For the following devices, you will have 4 months to register with the MHRA (until 30 April 2021):
- Active implantable medical devices
- Class III medical devices
- Class IIb implantable medical devices
- IVD List A
For the following devices, you will have 8 months to register with the MHRA (until 31 August 2021):
- Class IIb non-implantable medical devices
- Class IIa medical devices
- IVD List B
- Self-test IVDs
For the following devices, you will have 12 months to register with the MHRA (until 31 December 2021):
- Class I medical devices
- General IVDs
Registration for custom-made devices will be in line with the risk class of the device. Failure to register by these dates will mean that you will no longer be able to lawfully place your device on the UK market. Click here to read more information.
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