From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for UK Medical devices that are currently undertaken through the EU system. As things are becoming more complex, we’ve outlined the most important considerations when exporting medical devices to the UK.
Key points to consider
- The term ‘medical device,’ also includes in vitro and active implantable medical devices
- There is separate guidance for other CE marked products entering the UK market. For more information, click here
- Different rules will operate in Northern Ireland compared to Great Britain (England, Wales and Scotland).
- There are still legislative proceedings pending to finalise the guidance notice proposed by the MHRA.
- If you are unsure about which regulatory framework applies to your goods, please consult our Brexit experts.
Summary of requirements for placing a medical device on the UK market
- CE marking will continue to be recognised in Great Britain until 30 June 2023
- Certificates issued by EU-recognised Notified Bodies will continue to be valid for the GB market until 30 June 2023
- After the transition period, the EU will no longer recognise UK Notified Bodies
- UK Notified Bodies will not be able to issue CE certificates (other than for the purposes of the “CE UKNI” marking, which will be valid in Northern Ireland) – and will become UK Approved Bodies from 1 January 2021
- 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
- From 1 January 2021, all medical devices including in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA.
Grace Period Timeline for Medical Devices
– Class IIIs implantables
– Class IIb implantables
– All active implantable medical devices
– IVD List A products – Other Class IIb devices
– Other Class lla devices
– IVD List B products
– Self-Test IVDs – Class I devices
– Custom-made devices
– General IVDs (that do not currently need to be registered)
1 May 2021 1 September 2021 1 January 2022
- Manufacturers of Class I devices, custom-made devices and general IVDs that are currently required to register their devices must continue to register their devices from 1 January 2021 as they do now until the new registration requirements begin to apply
- If you are a manufacturer based outside of the UK and wish to place a device on the GB market, you will need to appoint a single UK Responsible Person who will take responsibility for the product in the UK.
UK Responsible Person
- Manufacturers should aim to appoint their UK Responsible Persons as soon as possible, where required
- The MHRA will only register devices where the manufacturer of their UK Responsible Person has a registered place of business in the UK
- If the business is based outside of the UK, they will need to appoint a UK Responsible Person that has a registered place of business in the UK
- This person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA
- The Responsible Person or manufacturer should regularly keep updated with the information held by the MHRA to ensure it doesn’t change or update
- Where any changes to registrations are made, a £100 standard fee per application will apply
- It will be possible for manufacturers to register devices in different classes that are subject to different grace periods at the same time
- Registration for custom-made devices will be in line with the risk class of the device. Failure to register from these dates will mean that you will no longer be able to lawfully place your device on the Great Britain market
- The UK Responsible Person will act on behalf of the outside-UK manufacturer to carry out the specified tasks. This includes registration with the MHRA.
- The responsibilities of the UK Responsible Person will be set out in the UK MDR 2002 (in the form in which they exist on 1 January 2021)
The UK has left the EU and from 1 January 2021, manufacturers importing medical devices to the UK will need to take into consideration the information held by the MHRA to ensure that devices remain legally authorised for distribution in the UK market. There are different grace periods for specific devices that should be considered.
If you are exporting to Nothern Ireland, different rules apply. If you do not have a registered place of business in the UK, you will need to appoint a UK Responsible Person to carry out manufacturer tasks, including registration with the MHRA.
Certification Experts can help you with UKCA marking and regulation. We can also act as your UK Responsible Person.
As of 1 July 2023, the MHRA has raised their registration fee to £240.
Secondly, the MHRA communicated they will extend the recognition of the CE marking on medical devices:
- CE marking on medical devices certified under EU IVDD by a CE Notified Body is recognised until 30 June 2030,
- CE marking on medical devices certified under EU MDR and EU IVDR is recognised until 30 June 2030.
The EU MDR transition period with regards to legacy devices is recognised by the MHRA as well:
- CE MDD certificates issued by CE Notified Bodies for Class IIb implantable devices and Class III medical devices, are under conditions recognised to 31 December 2027,
- CE MDD certificates issued by CE Notified Bodies for other Class IIb medical devices, Class IIa medical devices and Class Im, Is, Ir medical devices are under conditions recognised until 30 December 2028. However, they can only be placed on the market until 30 June 2028,
- For upclassified Class I devices (that newly require involvement of a notified body under EU MDR), the EU MDD Declaration of Conformity will be valid until 30 June 2028.
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