Timeline of proposed changes to the UK regulatory framework for medical devices

Last updated: 28 March 2024

See updates at the end of the post.

This post is an attempt to outline the timeline of proposed changes to the UK regulatory framework for medical devices, including the transitional arrangements.

The regulations will be delivered through four Statutory Instruments. It is intended that priority measures to enhance post-market surveillance will be put in place first in 2024, with core elements of the new framework expected to be in place in 2025.

Table 1
DateItem/EventImplementation (where applicable)
Sept-Nov 2021Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK).
The aim was to seek views on developing a future legislation for medical devices which delivers:
• improved patient and public safety
• greater transparency of regulatory decision making and medical device information
• close alignment with international best practice, and
• more flexible, responsive and proportionate regulation of medical devices
26 Jun 2022The UK Government response to consultation on the future regulation of medical devices in the United Kingdom was published.
Statutory Instrument (SI) on Transitional arrangements
(The Medical Devices (Amendment) (Great Britain) Regulations 2023

Draft laid in parliament on 27 April 2023 and signed into law on 9 June 2023.
A statutory instrument (Draft Medical Devices (Amendment) (Great Britain) Regulations 2023) was laid in Parliament on 27 April 2023 to enable an extended timeframe for acceptance of CE marked medical devices on the Great Britain market (i.e. beyond 30 June 2023) .

On 23 May 2023 in the House of Commons (5. Statutory Instruments: Motions for Approval, point no 7) and on 8 June 2023 in the House of Lords, the motion that the Draft Medical Devices (Amendment) (Great Britain) Regulations 2023 be approved, was agreed. Subsequently, the Statutory Instrument was signed into law on 9 June 2023. The full timeline of the proceedings in parliament can be viewed here.

Now that this statutory instrument (SI) has come into force, it amends the end of the standstill date (of 30 June 2023) in the current UK Medical Devices Regulations (UK MDR 2002) and introduces the transitional arrangements for CE and UKCA Marked Devices. More information on these transitional arrangements is provided below.

This will mean that CE marked medical devices will be accepted on the Great Britain market beyond the current deadline of 30 June 2023.

Regulations 1 to 4 of the SI came into force on 30 June 2023 and the remainder on 1 July 2023.
Statutory Instrument on Post-Market Surveillance






Further to the consultation on the future regulation of medical devices in the UK, the government also intends to introduce legislation later in 2023 that will bring into force strengthened Post-Market Surveillance requirements (PMS) ahead of the wider future regulatory regime. This reflects the government’s priority of improving patient safety as part of the future medical device regulations.


on 26 July 2023, the World Trade Organisation (WTO) published notification of the draft Post-market Surveillance Requirements Statutory Instrument (PMS SI) .  
The WTO notice a link to the draft PMS SI, providing interested stakeholders with early notice of the intended legislative changes.

The draft PMS SI included:
· Detail on what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers.
· Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner.
· More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices. This aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device.

The comment period for the WTO notification closed 25 September 2023.

The MHRA are now giving the responses to that review careful consideration. The government intends for the PMS statutory instrument (SI) to be laid in the first part of 2024 and it is expected to apply towards the end of 2024.  Accompanying guidance will also be published.
———————————————
Under the UK-EU Trade and Cooperation Agreement, technical regulations are subject to a six month implementation period between the publication of the final regulations and the regulations apply fully and this is a mandatory requirement.

As the PMS requirements constitute as technical regulations, they will be subject to a six month implementation period. Therefore, it is expected that the the PMS requirements will apply from mid-2024.
Towards the end of 2024
9 Jan 2024An announcement on the implementation of the future regulations was first published on 25 Oct 2022 and has since been updated several times. The guidance was updated on 9 Jan 2024  with a Roadmap towards the future regulatory framework for medical devices  which sets out intended timescales for delivery of the future core regulations.
2024SaMD guidance published: Data-driven SaMD research, development and governance

Future core regulations stakeholder discussions: unique device identification and implantables, transitional arrangements

Future enhancement regulations: public consultation

Future core regulations: draft legal text published by World Trade Organization

PMS regulations in force
The government intends for the PMS statutory instrument (SI) to be laid in the first part of 2024 and it is expected to apply towards the end of 2024.  Accompanying guidance will also be published.
2025Future core regulations laid in Parliament

Future core regulations in force
The core elements of the new framework are expected to be in place in 2025.
Transitional arrangements that apply now that the Statutory Instrument on Transitional Arrangement ((Draft Medical Devices (Amendment) (Great Britain) Regulations 2023) has come into force

The government has put in place legislation in Spring 2023 to extend the acceptance of CE marked medical devices on the Great Britain market. This will support the ongoing safe supply of medical devices to Great Britain and ease the transition to the future regulatory framework for medical devices.

Now that the Statutory Instrument on Transitional arrangements ((Draft Medical Devices (Amendment) (Great Britain) Regulations 2023) has come into force (Regulations 1-4 on 30 June 2023 and the rest on 1 July 2023), it provides that CE marked medical devices may be placed on the Great Britain market according to the timelines in Table 2 below:

Table 2
Device Type Timeline for placing on the Great Britain market
General medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking Can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
In vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) 
Can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030
General medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR)Can be placed on the Great Britain market up until the
30 June 2030.

This will enable certain CE marked medical devices to continue to be placed on the Great Britain market for longer.

The legislation provides that you can place self-declared CE marked Class I medical devices on the GB market beyond 30 June 2023 if they are:

  • self-declared against EU MDR requirements (until 30 June 2030), or
  • self-declared against MDD requirements before 26 May 2021 where Notified Body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028). This includes upclassified devices and reusable surgical instruments.

It also provides that you can place a Class I medical device which has a sterile or measuring function with a valid MDD certificate on the GB market until 30 June 2028.

  • Class I medical devices and general IVDs under the Directives, for which the conformity assessment under the EU MDD or EU IVDD did not require a notified body, can only be placed on the Great Britain market if the involvement of a notified body would be required under the EU MDR or IVDR (i.e., if it is an upclassified device or a reusable surgical instrument Class I device). 
  • Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.

If placing medical devices on the Great Britain market under these transitional measures, manufacturers will not be able to rely on expired certificates (unless such certificates have been otherwise deemed valid by the EU).

You can download an infographic of the timelines for placement of CE marked medical devices on the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023.

Future Core Regulations

During the first half of 2024 the MHRA intends to run stakeholder discussions on the future core regulations to give early sight of the detailed policy, developed from the policy positions in the consultation response.

The future core regulations will enable greater international collaboration and practices, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances.

For more more specific information on the Future Core Regulations, please refer to this page.

MHRA statement following UK Government announcement on the extension of CE mark recognition

On 1 August 2023, The Department for Business and Trade announced an indefinite extension to the use of CE marking for UK businesses.

The Medicines and Healthcare Regulatory Agency (MHRA) has since released a statement on CE marking recognition for medical devices and in vitro diagnostics, the first sentence of which states that the extended recognition of CE marking announcment does not apply to medical devices or IVDs.

The UK government has already put in place legislation that amends The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of CE marked medical devices on the Great Britain market. More specifically, legislation now enables CE marked medical devices to be placed on the Great Britain market to the following timelines:

For the timelines for the placement of medical devices on the Great Britain market, please see Table 2 above.

Further Information
  1. MHRA MedTech Regulatory Reform Webinar – 5 March 2024
  2. UK MDR: further delays, unexpected developments? – Alex Denoon et al, Bristows LLP, 23 January 2024
Sources:
  1. Standard Implementation of the Future Regulations
  2. Regulating Medical Devices in the UK
  3. Medical Devices Regulations webinar – 24 Jan 2023
  4. UK Government announces extension of CE mark recognition for businesses -1 August 2023
  5. MHRA statement on on CE marking recognition for medical devices and in vitro diagnostics – 1 August 2023
Updates
DateUpdate(s)
28 Mar 2024Under the section Further Information, link added to MHRA MedTech Regulatory Reform Webinar – 5 March 2024
7 Feb 20241. New 2nd paragraph added at the beginning of the post, starting “The regulations will be delivered through four Statutory Instruments…….. etc.”
2. Table 1 has been update to reflect the current available information. Specifically, the rows for 2024 and 2025 have been updated.
3. New section entitled Future Core Regulations added.
4. New section entitled Further Information added.
9 Jan 2024Table 1 was updated to include a link to the Roadmap towards the future regulatory framework for medical devices which was added to the announcement on the implementation of the future regulations which was was first published on 25 Oct 2022 and has since been updated several times.
1 Aug 20231) Section entitled MHRA statement following UK Government announcement on the extension of CE mark recognition
2) Administrative changes made to improve the readability of the post.
28 Jul 2023Table 1 updated to provide Information on the Notification of the draft Post Market Surveillance SI published on 26 July 2023
19 Jun 2023The following updates have been applied in line with the MHRA updates of 16 June 2023:

1) In Table 1, the section on Statutory Instrument on Transitional arrangements has been updated.
2) The text under Table 2 has been updated.
3) Sources of Information have been updated.
8 May 2023Post updated to reflect latest information from the MHRA.
25 March 2023Text under the section entitled Will there be any impact from the extension of Medical Device Regulation (MDR) transitional period and the validity of certificates in the EU? updated to add information on the publication of Regulation (EU) 2023/607.
21 Feb 2023Added heading Will there be any impact from the extension of Medical Device Regulation (MDR) transitional period and the validity of certificates in the EU? plus relevant content.