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

Last updated: 25 October 2026

To see updates, click on the ‘+’ sign below.

Date	Update(s)
25 Oct 2026	i) Post including Table 1 updated substantially to improve readability. ii) Table 1 updated in line with MHRA website to reflect that on 21 October 2026, the UK government confirmed that it will continue to accept CE marked medical devices on a long-term basis. Further information regarding this added after the table.
11 May 2026	Table 1 updated to provide information from the MHRA MHRA concerning new pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the GB market have been published by the MHRA on the World Trade Organisation notification portal on Friday 8th May 2026.
16 Feb 2026	In Table 1: i) Further information was added concerning the planned statutory instrument on pre-market requirements which will introduce additional measures before a device can be put on the market. ii) Link was added to the MHRA consultation on indefinite recognition of CE marked medical devices.
11 Oct 2025	Table 1 updated to add information on the date (16 October 2025) from which all medical device manufacturers must use the new Great Britain (GB) data schemas to report safety incidents about medical devices to the MHRA. Appropriate links have also been added.

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

Date	Item/Event	Notes and links as applicable
Sept-Nov 2021	Between 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 2022	The 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 No. 627) 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.
26 July 2023	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.
21 May 2024	The MHRA Consultation on common specification requirements for in vitro diagnostic devices was held between 21 May 2024 and 14 June 2024. The government response to the consulation was published on 10 July 2025. (see below)
3 Jul 2024	Standard: Statement of policy intent: International recognition of medical devices. This statement describes the draft policy for recognition by the UK of international regulators’ approvals of medical devices. This statement and proposed framework applies to medical devices in Great Britain.
14 Nov 2024	The Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices was held between 14 November 2024 and 5 January 2025. The government response was published on 22 July 2025. See below.
11 Dec 2024	An 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 last updated on 9 Jan 2024 with a revised Roadmap towards the future regulatory framework for medical devices (Version 2.0 Dec 2024) which sets out intended timescales for delivery of the future core regulations.
16 December 2024 The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024	The Draft Post-market Surveillance (PMS) Statutory instrument (SI) laid in parliamaent on 21 October 2024 was the first major update to the framework of medical device regulations in Great Britain, led by the MHRA. For a summary of the key changes to the regulation, see the Implementation of Future Regulations document here. A suite of guidance has also been published by the MHRA and includes guidance on the following: • Post-market surveillance requirements • Supplementary guidance on a manufacturer’s vigilance system • Periodic safety update reports • Device-specific vigilance guidance This guidance is designed to help medical device manufacturers understand and prepare for the new Post-market surveillance (PMS) regulation for medical devices in Great Britain (GB) which will come into force on 16th June 2025. Key new requirements are: • enhanced data collection • shorter timelines for reporting serious incidents • summary reporting to enable the MHRA and manufacturers to identify safety issues earlier • clearer obligations for risk mitigation • communication to protect patients and users. Businesses are encouraged to start using the guidance straight away so that they understand their obligations and are ready to comply with the regulations when they take effect. These new regulations: • are part of wider regulatory reform and will introduce clearer and more risk-proportionate PMS requirements that improve the safety of medical devices across GB and provide certainty for manufacturers. • will apply to medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices, in use in GB. However the PMS requirements vary based on the risk level posed by the device to patients. The guidance will provide additional detail on these requirements to support manufacturers with their PMS activities and help to ensure their devices continue to meet appropriate standards of safety and performance. Source: MHRA	The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 was signed into law on 16 December 2024, and came into effect on 16 June 2025.
23 January 2025 The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025	A Draft Statutory Instrument (SI) laid in Parliament on 21 October 2024 will provide a new regulatory framework meaning that medicines with a very short shelf life and highly personalised medicines can more easily be made in or near a hospital setting and can get to the patients who need them safely and much more quickly. The regulation will also allow for manufacture of innovative medicines in small, portable units that can be set up close to patients who may be too sick to travel or whose reduced immunity precludes travel or where rapid medicine availability is best served.	The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 was signed into law on 23 January 2025 and came into effect on 23 July 2025 Further information is available on this page on the MHRA website, in this MHRA webinar of 28 January 2025 and in this blog post.
26 February 2025	First part of the government response to the MHRA Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices was published. This document sets out the responses to the public consultation on the proposed amendments to the Medical Devices Regulations 2002 regarding four specific pieces of assimilated EU law only The second part of the response was published on 22 July 2025. Linked provided further in the table.
10 July 2025	The government response to the MHRA Consultation on common specification requirements for in vitro diagnostic devices was published.
22 July 2025	Second part of government response to the Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices was published.
16 October 2025 This is the date from which all medical device manufacturers must use the new Great Britain (GB) data schemas to report safety incidents about medical devices to the MHRA.	The new GB data schemas must be used when submitting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action reports (FSCAs) to the MHRA for medical devices in use in GB. This follows the new Post-marketSurveillance Requirements) (Amendment) (Great Britain) Regulations 2024 , which came into effect on 16 June 2025, to provide more safety information on medical devices in use across England, Scotland and Wales. The new regulations enable the MHRA and the whole health system to manage risks and contain safety issues swiftly, to better protect patients. The technical implementation period for the new reporting requirements ends on 16 October 2025. From this date the new GB data schemas must be used for all reports to the MHRA on the Manufacturers Online Reporting Environment (MORE) portal. Guidance on Documentation for implementation of data requirements under the new Post-Market Surveillance regulations is available here on the MHRA website. Guidance on MORE implementation is available here on the MHRA website. Source: MHRA via LinkedIn
16 February 2026	The Government response to its Consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices was published in two parts on 26 February 2025 and 22 July 2025. The results have informed the planned statutory instrument on pre-market requirements which will introduce additional measures before a device can be put on the market. You can read more on this page in Section 3. Pre-market Statutory Instrument (SI) Source: MHRA
16 February 2026	MHRA launches a consultation on indefinite recognition of CE-marked medical devices. The response to the consultation was published on 21 October 2026. Link provided further in the table.
8 May 2026 Draft Medical Devices (Amendment) Regulations 2026 published	New pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the GB market have been published by the MHRA on the World Trade Organisation notification portal on Friday 8th May 2026. The notification provides an opportunity for WTO members to comment on the draft pre-market regulatory requirements, titled the Draft Medical Devices (Amendment) Regulations 2026. The MedTech industry, approved bodies, healthcare providers and patients are also invited to share their views on the impact of the proposed changes via an MHRA survey. Responses will inform the Impact Assessment and future implementation of the regulations. The MHRA values any views that are relevant to you or your organisation. Please respond to the survey by Friday 19 June 2026. Here, you can view the Guidance – Questionnaire on the Impacts of MHRA’s 2026 Regulations. You can respond online here. The draft Medical Devices (Amendment) Regulations 2026 bring forward patient-centred and proportionate regulatory requirements to prioritise patient safety and access to innovative medical technologies. They are designed to: i) give faster access to safe and innovative medical devices and support economic growth and innovation in the UK MedTech sector. ii) introduce a framework to enable swifter access for devices already approved by regulators in Australia, Canada and the USA. iii) require healthcare organisations that implant medical devices to give patients implant cards that provide information about the device that was implanted, improving ability to manage adverse events, and transparency for patients. iv) make unique device identifiers (UDI) compulsory to enable precise identification and traceability of devices throughout their lifecycle. v) align classifications of in vitro diagnostic (IVD) devices with those of the International Medical Device Regulators Forum (IMDRF) standards. vi) align the essential requirements for medical devices in Great Britain with best international practice. vii) strengthen the requirements for technical documentation retention to ensure this information is kept for an appropriate period. viii) include new requirements for custom-made devices to improve traceability and enable electronic prescriptions. ix) require manufacturers to align claims about their medical devices with their statement of intended purpose. Source: MHRA, MHRA(2) Further Reading: Draft UK Medical Device Amending Regulations: Key Proposals and MHRA Call for Evidence, 11 May 2026, Eleri Abreo, Arnold & Porter.
21 October 2026	Consultation The government response to its consultation Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices was published.
21 October 2026	The UK government confirmed that it will continue to accept CE marked medical devices on a long-term basis following the public consultation Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices. See further information below.

UK Government confirms indefinite recognition of CE marked medical devices

The UK government confirmed on 21 October 2026 that it will continue to accept CE marked medical devices on a long-term basis.

The decision follows a public consultation, which ran from 16 February 2026 to 10 April 2026, that received more than 1,000 responses from patients, healthcare organisations, industry and others. You can view the consultation outcome here.
This means that patients across Great Britain will continue to have access to the medical devices and in vitro diagnostic devices (IVDs) they rely on, from insulin pumps and replacement joints to diagnostic tests and surgical equipment.
The decision means the UK will not require an additional approval route for devices already approved for the EU market, avoiding duplication for manufacturers and helping to maintain stable supply and patient access to medical technologies.
More than 90% of medical devices registered for use in Great Britain currently carry a CE mark, meaning they have been assessed and approved for the European market, and this approval has been recognised to provide access to the Great British market.
Continuing to recognise these devices will help maintain safe, uninterrupted access to the treatments and technologies that patients and the NHS rely on.
This sits alongside the UKCA marking route, which continues to operate as the domestic approval pathway for devices placed on the market in Great Britain.
These arrangements sit alongside strengthened post-market surveillance and reporting requirements already in place.
The MHRA will continue to oversee all devices on the UK market, monitor safety through mechanisms including the Yellow Card scheme, and work closely with international partners to share safety information enabling the MHRA to take action to protect patients where needed.
In parallel, the UKCA route remains the current domestic approval route for medical devices placed on the market in Great Britain.
This is being modernised through the pre-market statutory instrument, which will update the requirements that devices must meet to be UKCA marked.
Alongside this, the MHRA will continue to seek enabling powers through primary legislation to develop a future licencing approach for medical devices, intended to support a more modern and adaptable framework that is better able to respond to advancing medical technologies, including software and AI medical devices, reflecting recommendations from the National Commission into the Regulation of AI in Healthcare.

Source: MHRA

Table 1

UK Government confirms indefinite recognition of CE marked medical devices

Further reading