# Implementation of medical devices future regime Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/930db4d5-c409-4315-bcb8-6770b3ad9fef Type: Standard Published: October 24, 2022 Updated: March 12, 2026 > This guidance document from the UK Medicines and Healthcare products Regulatory Agency (MHRA) details the evolution of the Medical Device Regulations 2002 and the transition toward a modernized regulatory framework. Rather than a specific company inspection, the document addresses industry-wide updates spanning from June 2022 to December 2025. The primary focus is on resolving gaps in patient safety by implementing robust monitoring requirements. The Post-Market Surveillance legal requirements, signed into law on December 16, 2024, establish clearer obligations for tracking devices after they reach consumers. The regulatory framework is further bolstered by a policy intent to recognize international regulator approvals and a specific roadmap for In Vitro Diagnostic (IVD) devices extending to mid-2027. To remain compliant, manufacturers and stakeholders are required to follow the revised roadmaps, adapt to the new legal standards, and participate in ongoing consultations regarding how products are brought to market. This strategy aims to harmonize UK standards with international best practices while ensuring high levels of device performance and safety. Organizations are encouraged to coordinate with trade associations like the Association of the British HealthTech Industries for further guidance and preparation. --- ## Content Overview This information is to support you to understand and prepare for the main regulatory updates and upcoming amendments to the Medical Device Regulations 2002 . How the regulations were developed On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom . The response outlined the intended regulatory reform including the transitional arrangements for CE marked devices placed on the Great Britain market which were put in place in 2023. On 9 January 2024, the MHRA released a roadmap towards the future regulatory framework for medical devices. This provided an update on the intended timelines to implement the future core regulations. On 21 May 2024, following on from stakeholder discussions throughout the first quarter of 2024, the MHRA released a statement of policy intent for recognition by the UK of approvals of medical devices from international regulators . This statement sets out the MHRA proposed policy approach. The final legal text would come into force at the same time as the future core regulations. On 21 October 2024 the draft Post-Market Surveillance Statutory Instrument was laid in Parliament. The new regulations introduce clearer and more robust requirements for post-market surveillance (PMS) that improve patient safety. The Post-market Surveillance Statutory Instrument was signed into law on 16 December 2024. On 14 November 2024, the MHRA published the Consultation on medical devices regulations: routes to market and in vitro diagnostic devices . The results of this consultation will inform legislative updates to the regulatory framework. On 11 December 2024, the MHRA published a revised Roadmap towards the future regulatory framework for medical devices . This provides a further update on the intended timelines to implement the future medical device regulations. On 15 December 2025, the MHRA published an In Vitro Diagnostic (IVD) Medical Device Road Map . This roadmap outlines the planned priority deliverables for the IVD medical device work programme until mid-2027. Contact For further information, contact our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your trade association: Association of the British HealthTech Industries (ABHI): enquiries@abhi.org.uk British In Vitro Diagnostics Association (BIVDA): enquiries@bivda.org.uk Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk The British Healthcare Trades Association (BHTA): info@bhta.com UK Responsible Persons Association (UKRPA): enquiries@ukrp-association.org ## Attachments - [Infographic: Timelines for placement of CE marked medical devices on the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023](https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf) - [Implementation of the future regulations](/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations) - [Roadmap towards the future regulatory framework for medical devices](https://assets.publishing.service.gov.uk/media/6759a8827e419d6e07ce2b21/Med_Tech_Regulatory_Roadmap_V2_December_2024.pdf) - [Statement of policy intent: international recognition of medical devices](/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices) - [ANNEX A- Detailed response to WTO comments for The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Draft Regulations 2023](https://assets.publishing.service.gov.uk/media/671617e76ab48d81c5f7eb22/Annex_A_detailed_response_to_WTO_comments.pdf)