[co-author: Ashley Florestal]
The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern Ireland following the expiry of the Brexit transition period under the EU-UK Withdrawal Agreement on 31 December 2020.
The Guidance is of relevance to all medical device companies operating or selling devices in the UK. It retains many of the elements of the MHRA's previous "no-deal" Brexit guidance but differs in certain respects, including setting a clear timeline for a new UK medical device regulation framework from July 2023.
Current status of Brexit
The UK left the EU on 31 January 2020 and existing EU medical device legislation has continued to apply in the UK under the terms of the EU-UK Withdrawal Agreement during the Brexit transition period. When that period expires on 31 December 2020, existing EU legislation will be automatically incorporated into UK domestic legislation to the extent possible.
Any EU legislation that take effect after this date will not automatically apply in the UK (unless the EU and UK agree a new trading relationship that provides otherwise, which is currently still under negotiation). The Guidance confirms that as the new EU Medical Devices Regulation ("MDR") and In Vitro Diagnostic Medical Devices Regulation ("IVDR") will take effect in the EU after 1 January 2021, they will not automatically apply in the UK.
The new MHRA Guidance
The Guidance set outs out how devices will be certified, conformity marked and registered in GB and Northern Ireland, which together make up the UK, from 1 January 2021. Different rules will apply in Northern Ireland than in GB as a result of the Northern Irish Protocol (see below). The Guidance will be given effect via legislation before the end of 2020 and is therefore still subject to Parliamentary scrutiny.
In summary, the key elements are:
- CE marking and CE Certificates of Conformity issued by European Economic Areas ("EEA") based Notified Bodies will continue to be recognised in the GB market until 30 June 2023.
- After this date, in order to place a medical device on the market in GB, a new route to market culminating in a "UKCA" (UK Conformity Assessed) mark will replace the CE mark. The UKCA route will be optional from 1 January 2021 and mandatory from 1 July 2023. The UKCA requirements are still being developed and will "take into consideration international standards and global harmonisation".
- From 1 January 2021, UK Authorised Representatives and certificates issued by UK Notified Bodies will no longer be recognised in the EEA.
- Manufacturers based outside the UK who wish to place a device on the GB market will need to establish a UK Responsible Person who will take responsibility for the product in the UK (see below for further detail).
- All medical devices and in vitro diagnostic medical devices placed on the UK market will need to be registered with the MHRA from 1 January 2021, subject to the following grace periods:
- 4 months (until 30 April 2021) for Class III medical devices, Class IIb implantables, all active implantable medical devices and List A IVDs;
- 8 months (until 31 August 2021) for all other Class IIb medical devices, as well as all Class IIa medical devices, and List B and self-test IVDs;
- 12 months (until 31 December 2021) for the subset Class I devices and general IVDs that are not already required to register with the MHRA under the existing rules - there will be no grace period for Class I devices and general IVDs that are already required to be registered with the MHRA; and
- The registration of custom-made devices will be in line with the risk classification of the device.
- Devices can be dual labelled with the CE mark and UKCA mark.
UK Responsible Persons
From 1 January 2021 (subject to the same grace periods as for registration above), in order to place a device on the GB market, manufacturers must either have a legal presence in the UK or appoint a UK-based responsible person ("UK RP") to act on their behalf. The UK RP will then assume the responsibilities of the manufacturer in relation to the registration of the device including registration of the device with the MHRA in accordance with the grace periods above.
UK RP responsibilities will include:
- Checking that the manufacturer has a valid Declaration of Conformity and technical documentation and, where applicable, that an appropriate conformity assessment procedure has been carried out.
- Liaising with the MHRA, including providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device on request, reporting suspected incidents and co-operating on any preventive or corrective actions.
UKCA mark and Notified Bodies
Existing UK Notified Bodies will automatically become "Approved Bodies" and able to conduct UKCA conformity assessments for the UKCA mark process. The UKCA mark will only be recognised in GB; it will not be recognised in the EEA or Northern Ireland. Certificates issued by UK-based Notified Bodies will no longer be recognised by the competent authorities in the EEA. The following transitional arrangements will be in place:
Placing a medical device on the Northern Irish market
EU medical device legislation will continue to apply in Northern Ireland, with the same timings for the implementation of the MDR and IVDR as in the EEA. The CE mark will remain a requirement for devices placed on the market in Northern Ireland. Most medical devices will need to be registered with the MHRA before being placed on the market in Northern Ireland.
Placing a UK made medical device on the EU market
From 1 January 2021, devices manufactured in the UK but destined for the EU market will need to adhere to the relevant EU legislation and bear the CE mark. In practice this means:
- If a device has been assessed by a UK-based Notified Body and placed on the EU market before 1 January 2021 then, in accordance with the terms of the EU-UK Withdrawal Agreement, it can remain on the EU market.
- From 1 January 2021 onwards, it will not be possible to place new devices on the EU market unless the conformity assessment has been conducted by an EEA-based Notified Body.
GB-based Authorised Representatives will not be recognised in the EU from 1 January 2021, regardless of when products were placed on the market, so an Authorised Representative based in the EEA or Northern Ireland will be required.
Further guidance to come
While the Guidance clarifies many aspects of the post-transition regulatory environment for medical devices in the UK, there are still some areas to clarify and further guidance, including on the UKCA route and UK RPs, is anticipated in the coming months.