Following a short debate in the Delegated Legislation Committee on 22 May 2023, the House of Commons unanimously approved the draft Medical Devices (Amendment) (Great Britain) Regulations 2023 (the Amending Regulations).[1]

The Amending Regulations will now be debated by the House of Lords. They are expected to come into force on 30 June 2023.

The Amending Regulations will amend the Medical Devices Regulations 2002/618 (UK MDR) to extend the transitional periods during which medical devices and in vitro diagnostic medical devices (IVDs) which have been CE Marked in accordance with EU law can be commercialised in Great Britain.

Consequently:

• “legacy” medical devices which have been CE Marked in accordance with the EU MDD[2] or the EU AIMDD[3] will be able to be commercialised in Great Britain until 30 June 2028 at the latest.
• medical devices which have been CE Marked in accordance with the EU MDR[4], will be able to be commercialised in Great Britain until 30 June 2030 at the latest; and
• IVDs which have been CE Marked in accordance with the EU IVDR[5] or the EU IVDD[6] will be able to be commercialised in Great Britain until 30 June 2030 at the latest.

But for the Amending Regulations, from 30 June 2023, it would not be possible to place on the market (or put into service) in Great Britain any medical device or IVD which is CE Marked in accordance with with EU law.

Background to the Amending Regulations

The Amending Regulations are the first in a series of amendments to the UK MDR that will introduce Great Britain’s new regulatory framework for medical devices.

The Amending Regulations merely give the government more time to introduce the new regulatory framework by extending the period of time in which medical devices and IVDs bearing a CE Mark can continue to be marketed in Great Britain.

The Amending Regulations are also partially a response to the EU’s recent decision to significantly extend the transition periods under the MDR for medical devices which have been CE Marked under the MDD or AIMDD, as a result of capacity constraints in the transition to the EU MDR.

The new regulatory framework for medical devices will be substantially aligned with the current EU regulatory framework, consisting of the MDR and IVDR. This was clear from the government’s response to a consultation carried out in 2022.[7]

The new regulatory framework promises to allow for “near-automatic approval” of medical devices and IVDs have already been authorised by a regulator in a “trusted jurisdiction” such as the United States, Japan and the EU.[8] It remains to be seen just how “near-automatic” this process will be and the extent of any additional hoops which manufacturers will have to jump through before placing medical devices and IVDs on the market in Great Britain.

When can we expect the new regulatory framework?

The MHRA has stated that it intends for the “core aspects” of the new regulatory framework to apply from 1 July 2025.[9]

This same date was referred to by the responsible Minister during the Delegated Legislation Committee’s debate of the Amending Regulations.

This date will be important for manufacturers of medical devices and IVDs who intend to continue to place such devices on the market in Great Britain on the basis of CE Markings during the extended transition periods introduced by the Amending Regulations. The MHRA has stated that it intends to introduce a further amendment under which CE Certificates issued under the MDR or IVDR which are renewed after 1 July 2025 will no longer be valid in Great Britain during the transition period.[10] According to the MHRA’s submissions during the initial consideration of the Amending Regulations, this is intended to create an incentive for manufacturers to move from CE Marking to UKCA Marking.[11]

It appears that MDR and IVDR CE Certificates which are renewed after 1 July 2025 will no longer be recognised, but we understand that the MHRA intends that MDR and IVDR CE Certificates which are newly issued after 1 July 2025 will continue to be recognised until the end of the transition periods on 30 June 2030. This is a strange position which would appear to punish those manufacturers who obtained early CE Certification under MDR or IVDR. Such manufacturers will have to transition their devices to UKCA Marking sooner than many manufacturers who continue to rely on CE Certifications issued under the MDD, AIMDD or IVDD, or who have obtained CE Certifications under the MDR or IVDR less expeditiously.

Most likely, this is an intentional choice which is designed to avoid creating a single cliff-edge deadline for manufacturers to transition to UKCA Marking. As the EU has found in the transition to the MDR and IVDR, such deadlines often lead to a last-minute rush by manufacturers to obtain certification, which can cause a logjam where certification capacity is limited. The MHRA’s approach will at least have the effect of “spacing out” the points at which each manufacturer needs to transition to UKCA Marking. Nonetheless, this may not be a popular choice, and will create a coordination nightmare for manufacturers with very large portfolios of devices.

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[1] https://parliamentlive.tv/event/index/d3dd3181-7249-4b32-9285-f8077df1e130

[2] Medical Device Directive 93/42/EC

[3] Active Implantable Medical Device Directive 90/385/EEC

[4] Medical Device Regulation (EU) 2017/745

[5] In Vitro Diagnostic Medical Device Regulation (EU) 2017/746

[6] In Vitro Diagnostic Medical Device Directive 98/79/EC

[7] https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom

[8] https://www.gov.uk/government/speeches/spring-budget-2023-speech

[9] https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations

[10] See fn.9

[11] https://publications.parliament.uk/pa/ld5803/ldselect/ldsecleg/189/18903.htm