The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). This On the Subject outlines key dates for implementation of the new rules and certain practical implications of changed regime.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance (the Guidance) on new rules that will govern the regulation of medical devices after the end of the transition period. Whilst some of this guidance is similar to guidance issued as part of the “No deal BREXIT” publications in 2019, the MHRA has also set out proposals to engage and consult on a new medicines and medical devices regulatory framework for the UK.
The UK left the European Union (EU) in January 2020 but is currently in a transition period. The Guidance was released as part of a collection of updates covering various MHRA-regulated sectors (including medicines, clinical trials and licencing procedures) which will also be subject to new rules from 1 January 2021.
This update focuses on the new regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) placed on the market in England, Wales and Scotland (Great Britain) only. Different rules will apply to Northern Ireland.
Existing law to continue The rules that currently regulate medical devices and IVDs in the UK (through the Medical Device Regulations 2002) will continue to have effect in Great Britain after the transition period.
Will the new EU Medical Devices Regulation (MDR) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR) apply in the UK—and if so, when?
The MDR and IVDR will fully apply in the EU from 26 May 2021 and 26 May 2022, respectively.
The question as to the application of the MDR in the UK will be of key interest to medical device manufacturers, their supply chain and customers, many of which are working to achieve MDR compliance for EU markets.
The MDR was due to be implemented across the EU and UK from 26 May 2020. However, in early April 2020 the EU Commission proposed a one-year extension of the implementation date to avoid disruption and additional burdens on medical device manufacturers during COVID-19. This delay was approved by the EU Parliament and Council on 23 April 2020 and the new implementation date for the MDR is now 26 May 2021.
If this COVID-19 extension had not occurred, the MDR would have taken effect in the UK from 26 May 2020 and would have become part of UK legislation as “retained EU law” under BREXIT withdrawal legislation. Under this legislation, any retained EU law continues in full effect after 31 December 2020 unless changes are made by the UK parliament.
The effect of the COVID-19 delay is that the MDR will no longer automatically take effect in Great Britain. This position is reflected in the MHRA guidance. The IVDR will also not apply in Great Britain.
New medicines and medical devices legislation is currently in committee stage in the UK House of Lords in the form of the Medicines and Medical Devices Bill (Bill). The Bill is framework legislation, which will enable secondary legislation to be made for human medicines and devices. At this stage, the secondary legislation has not been published.
It is currently anticipated that the UK parliament will adopt the MDR and IVDR under the Bill.
However, in the guidance the MHRA has also said that there is an opportunity to develop a robust, world-leading regulatory regime for medical devices that prioritises patient safety. The MHRA goes onto comment that it will take into consideration international standards and global harmonisation in the development of future systems of regulation.
It is uncertain whether this statement indicates any intention to diverge from the MDR or IVDR in the future. In this context, the MHRA also refers to the Independent Medicines and Medical Devices Safety Review, which reported in July on the outcomes of the investigation into Primodos, sodium valproate and pelvic mesh. That report raised concerns about how the UK health system responds to patient safety issues and vigilance matters.
The MHRA has explained that it will be engaging with stakeholders within the life sciences and healthcare sectors on the proposed regime this autumn and that this will be followed by a formal public consultation with the stated aim of delivering an attractive world-class regulatory system.
The Guidance also provides an update on practical implications for manufacturers and distributors, which will come into effect after the transition period. Key points include:
- From 1 January 2021: Medical devices and IVDs will need to be registered with the MHRA before being placed on the Great Britain market. Certain grace periods apply depending on the class of the device as follows:
- From 1 January 2021: Manufacturers established in the UK will need to register with the MHRA. If they are not established in the UK, they will need to designate a UK Responsible Person. The same grace periods as set out above will apply for this appointment.
- From 1 January 2021: The introduction of a UK replacement to the CE mark (the UKCA mark) will come into effect from 1 January 2021 and this will run in parallel to the CE mark scheme for two years. Manufacturers are able to use the new UKCA mark from 1 January 2021. However, the MHRA will continue to recognise medical devices that have been approved for the EU market, and CE-marked, until 30 June 2023, including devices placed on the market under the EU MDR or EU IVDR. The UKCA mark will not be recognised in the EU; a CE mark will still be needed for those markets.
- From 1 January 2021: Devices that have been conformity assessed by a UK-notified body may not be placed on the EU market. Devices placed on the EU market before 1 January 2021 may remain on the EU market.
- From 1 January 2021: Great Britain manufacturers that self-certify will continue to be able to place their products on the EU market but must appoint an EU Authorised Representative.
- From 1 July 2023: New devices placed on the Great Britain market will need to conform with UKCA marking requirements.
- Until 30 June 2023: EU-notified body certificates will continue to be valid in Great Britain.
1 May 2021 for Class III and Class IIb implantables, and all active implantable medical devices 1 September 2021 for other Class IIb and all Class IIa devices 1 January 22 for Class I devices and general IVDs.
Different rules for Northern Ireland
Different rules will apply for Northern Ireland-based manufacturers. The key differences include:
- The MDR and IVDR will apply in Northern Ireland from 26 May 2021 and 26 May 2022 respectively.
- From 1 July 2023: An EU CE mark will be needed for devices placed on the Northern Ireland and UKCA marks will not be accepted on the Northern Ireland market unless accompanied by the CE or a CE mark (from a UK-notified body that is able to conduct a conformity assessment for Northern Ireland purposes).