OSA February 2021 Members’ Briefing
Medicines and Medical Devices Act 2021
- This new Act received Royal Assent on 11 February 2021. The Act gives the Government the power to make regulations to amend or add to the Medical Devices Regulations 2002. The Act also requires the Government to consult widely before amending or adding to the Regulations.
- The MHRA will be responsible for consulting on changes to the MDR 2002 and any new regulations. It is working with an industry liaison group, to develop proposals in specific areas. Consultation on new regulations is expected at some point during summer 2021.
- The MHRA has indicated that in developing new regulations it is interested in:
- transparency and patient engagement,
- pre-market assessment and authorisations, which could replace the current system,
- ensuring that new regulations are flexible enough to cope with rapid technological changes.
Post-Brexit regulatory changes
- The MHRA has reminded manufacturers to ensure that their products are registered by the appropriate deadline – 1 January 2022 for Class 1 devices.
- When registering, they encourage manufacturers to complete the ‘optional’ fields too because many will become legally required at a later date. Doing this now will save having to make a second registration later on.
- MHRA have said that the Northern Ireland situation is exacerbated because HPRA (the Irish regulator) is interpreting many aspects of the agreement differently from MHRA – this relates largely to border issues rather than regulatory controls. MHRA have asked for any evidence and examples of problems to be sent to them.
- The MHRA have published clips on YouTube on a range of issues for medical device manufacture and registration – https://www.youtube.com/user/MHRAgovuk/featured.
- Attached are set of slides published by the MHRA which set out the process and timetable for medical device regulation post-Brexit.
- MHRA has indicated that it wants manufacturers to make direct contact if they are struggling with the new system or want to help. MHRA can be contacted at
Key dates to note:
- 1 January 2021
- the Brexit transition period ends, the UK is no longer part of the EU and no EU legislation applies in Great Britain – however both British and EU legislation applies to medical devices in Northern Ireland
- new UKCA mark in use – although CE marks continues to be valid on Class 1 medical devices until 2023.
- all medical devices marketed in the UK must be registered with the MHRA – but different deadlines apply – for Class 1 medical devices the deadline is 1 January 2022.
- 11 February 2021 – the UK Medicines and Medical Devices Act received Royal Assent – this gives the UK power to change its regulatory system for medicines and medical devices.
- 26 May 2021 – the EU MDR takes full effect. This will be relevant if you market medical devices in the EU and in Northern Ireland
- 1 January 2022 – Class 1 medical device manufacturers and medical devices must be registered with the MHRA.