The Brexit transition period comes to an end on 31 December 2020 and from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator and will take on the responsibilities for the UK medical devices market.The MHRA has published new guidance on medical devices to help stakeholders prepare for the end of the transition period.
The following is a summary of the key points in this guidance that must be followed when putting a medical device on the Great Britain and European markets from 1 January 2021. NB under the terms of the Northern Ireland protocol, from 1 January 2021 the rules for placing medical devices on the Northern Ireland market will differ from those applicable to Great Britain. For full details please see here.
Further new and updated guidance may be issued depending on the precise terms upon which the UK leaves the EU, so stakeholders are advised to monitor these pages for updates.
Summary of key requirements for placing a device on the Great Britain market
- From 1 January 2021, all medical devices placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering of up to 12 months, depending on device class;
- If you are a manufacturer 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;
- The UKCA (UK Conformity Assessed) mark is a new UK product marking that will be used for medical devices being placed on the Great Britain market. The UKCA will not be recognised in the EU, EEA or Northern Ireland markets and products requiring a CE marking will still need a CE mark for sale in these markets;
- CE marking and certificates issued by European Economic Area-based Notified Bodies will continue to be used and recognised in Great Britain until 30 June 2023;
- From 1 July 2023, to place a device on the Great Britain market you will need to meet the requirements for placing a UKCA on your device.
Summary of key requirements for placing a medical device on the EU market
- From 1 January 2021, devices destined for the EU market will need to adhere to the relevant EU legislation and be affixed with a CE mark;
- Manufacturers based outside the EU will need to appoint an EU or Northern Ireland-based Authorised Representative;
- If you use a UK-based Notified Body (Approved Body) to conduct any mandatory third-party conformity assessment for your device:
- The device may remain on the EU market if it was placed on the EU market before 1 January 2021;
- From 1 January 2021, such assessments will not be recognised by the EU and the device will not be able to be placed on the EU market. (This is the case even if the assessment was carried out before the end of the transition period but where the product was not placed on the EU market before 1 January 2021.)
- If you wish to place a medical device on the EU market after 31 December 2020 that must undergo mandatory third-party conformity assessment, you will need to use an EEA-based Notified Body;
- If you currently CE mark your medical device on the basis of self-certification, you will be able to continue to do so after 1 January 2021 for the purposes of the EU market, but will need to appoint an EU or Northern Ireland-based Authorised Representative;
- Devices destined for the EU market must meet EU labelling requirements.
Special thanks to Emily Lockey, trainee solicitor, for drafting this summary
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