UK MHRA accept CE product until 30 June 2021 in Great Britain
The Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on 1 September 2020, which related with how medical devices will be regulated in the Great Britain after Brexit transition period (from 1 January 2021).
Summary of key requirements are as following:
CE marking will continue to be used and recognized in Great Britain until 30 June 2023
Certificates issued by European Economic Area (EEA)-based Notified Bodies (NB) 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 (after the Brexit transition period)
From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed in the UK market will need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). There will be a grace period for registering:
-4 months (until 30 April 2021) for Class IIIs and Class IIb implantable, and all active implantable medical devices
-8 months (until 31 August 2021) for other Class IIb and all Class IIa devices
-12 months (until 31 December 2021) for Class I devices
The above 12-month grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA.
A manufacturer based outside the UK and wish to place a device on the UK market, will need to establish a UK Responsible Person who will take full responsibility for the product in the UK.
A medical device which has been manufactured in Northern Ireland and registered with the MHRA for the purposes of marketing in Northern Ireland, can freely flow between Northern Ireland and Great Britain and will not need to undergo any further registration in Great Britain.
The UKCA (UK Conformity Assessed) mark is a new UK product marking that will be used for certain goods, including medical devices, being placed on the Great Britain market after the transition period.
The UKCA mark will not be recognized in the EU, EEA or Northern Ireland markets, and products currently requiring a CE marking will still need a CE mark for sale in these markets.
Manufacturers will be able to use the UKCA mark from 1 January 2021.
Devices that have been CE marked by Northern Ireland traders will continue to be accepted on the Great Britain market beyond 30 June 2023.
More detailed information can be consulted directly from the Guidance Document.
Given that this is an extension of existing registration requirements, there is a grace period to allow time for compliance with the new registration process. Devices must be registered in line with the timings set out below.
The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 May 2021:
active implantable medical devices
Class III medical devices
Class IIb implantable medical devices
IVD List A products
The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 September 2021:
Class IIb non-implantable medical devices
Class IIa medical devices
IVD List B products
The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 January 2022:
Class I medical devices
It is possible to register devices ahead of the above dates, but there is no legal obligation to do so.
Manufacturers of Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e. where the manufacturer is based in the UK or the Authorised Representative is based in Northern Ireland) must continue to register their devices on the same basis as they did previously as the above registration timings will not apply to these devices
Where a medical device was already registered with the MHRA before 1 January 2021, it does not need to be re-registered. However, manufacturers (or their UK Responsible Person) are required to review the information held by the MHRA to ensure it remains correct in line with the above dates.
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