The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on how medical devices will be regulated in the UK from 1 January 2021.
The key requirements for medical devices placed on the market in Great Britain from 1 January 2021 are:
- CE marking will continue to be used and recognised until 30 June 2023
- Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
- A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021
- If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK.
- From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
- 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices
- 8 months for other Class IIb and all Class IIa devices
- 12 months for Class I devices
The guidance also reveals that the new UKCA (UK Conformity Assessed) mark will be used for medical device and will be able to be applied from 1 January 2021. From 1 July 2023, to place a device on the Great Britain market, you will need to meet the requirements for placing a UKCA mark on your device. The UKCA mark will not be recognised in the EU, EEA or Northern Ireland markets. If you already have a valid CE mark on your device, you will not be required to re-label the device with a UKCA mark until 1 July 2023 for placement on the Great Britain market.
UKCA marks will be issued by new UK Conformity Assessment Bodies (CABs), which will be designated by MHRA. UK NBs with MDD designations will not have to undergo a new designation process.
The Department of Health and Social Care will be holding a webinar to discuss the guidance on Thursday 3rd September at 9:30am. The registration link can be found below.
Read the guidance here: https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021
Register for the DHSC webinar here: https://www.workcast.com/register?cpak=3123752941732861