MHRA – Draft Medical Devices Regulations 2026

Last Updated on 14/07/2026 by Katie Edgington

Click HERE to download the BHTA response to the MHRA pre-market medical devices regulation stakeholder impact survey.

MHRA has published its plans for future regulation of medical devices in the UK, draft Medical Devices (Amendment) Regulations 2026 (The Regulations). In line with the UK’s post-Brexit obligations under the World Trade Organization (WTO), MHRA notified the draft Regulations to the WTO on 8 May 2026; WTO members now have until 7 July 2026 to comment.

These Regulations represent the most significant reform of GB’s medical device framework in recent years, modernising pre-market requirements while improving access to devices already approved by other leading international jurisdictions. The Regulations will take effect in two phases:

• Spring 2027 – Access to the GB market (c. 6 months after laying the regulations in the UK Parliament in Q4 2026)
• Q2/Q3 2028 – International Reliance Pathways (c. 18 months after laying the regulations in the UK Parliament in Q4 2026)

MHRA Survey

MHRA requested that all interested stakeholders review the guidance questions for the Regulations and complete a survey on the impact of the Regulations by 19 June 2026. BHTA also completed the survey, but it was crucial that MHRA heard directly from industry, particularly manufacturers. The survey and supporting documents were available at:

• Press Release:  MHRA invites views on proposed changes to medical device regulation
• Survey Webpage:  Pre-market medical devices regulation – stakeholder impact survey
• Questions Guidance:  On the Impacts of The Medical Devices (Amendment) Regulations 2026
• Online Response Link:  Questionnaire on the Impacts of The Medical Devices (Amendment) Regulations 2026

Primary changes in the draft medical devices (amendment) regulations 2026

In summary, the main changes are:

1. Closer alignment with EU MDR and IVDR (adapted for GB)
2. Stronger control of claims and intended purpose
3. Reinforced lifecycle requirements
4. New requirements for custom made devices
5. New rules for software change management, such as Predetermined Change Control Plans (PCCPs) allowing manufacturers to pre-define certain future changes without repeated conformity assessments
6. International Reliance Pathway

In detail, the main changes are:

1. Give faster access to safe and innovative medical devices and support economic growth and innovation in the UK MedTech sector
2. Introduce a framework to enable swifter access for devices already approved by regulators in Australia, Canada and the USA
3. 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
4. Make unique device identifiers (UDI) compulsory to enable precise identification and traceability of devices throughout their lifecycle
5. Align classifications of in vitro diagnostic (IVD) devices with those of the International Medical Device Regulators Forum (IMDRF) standards
6. Align the essential requirements for medical devices in Great Britain with best international practice
7. Strengthen the requirements for technical documentation retention to ensure this information is kept for an appropriate period
8. Include new requirements for custom-made devices to improve traceability and enable electronic prescriptions
9. Require manufacturers to align claims about their medical devices with their statement of intended purpose

WTO Notification and relevant documents

The WTO notification is viewable at:  G/TBT/N/GBR/120 The Medical Devices (Amendment) Regulations 2026.

The draft Regulations are viewable at draft Medical Devices (Amendment) Regulations 2026 (The Regulations), and the underlying documents referred to the draft Regulations are viewable at:

• 2002:  UK Medical Devices Regulations 2002 [UK SI No. 618]
• 2020:  First Do No Harm – Report of the Independent Medicines and Medical Devices Safety Review [Cumberledge Review]
• 2021:  Consultation on the future regulation of medical devices in the United Kingdom [MHRA response 2022]
• 2024:  Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices [MHRA response 2025]
• 2024:  Consultation on Common specification requirements for in vitro diagnostic devices [MHRA response 2025]

Upcoming BHTA / AXREM webinar with MHRA

Following the survey, BHTA and AXREM hosted a joint webinar featuring speakers from the MHRA on Thursday 9 July 2026. The session provided an overview of recent regulatory developments and key updates from the MHRA relevant to industry stakeholders. Members who would like a copy of the presentation slides can request them by emailing katie.edgington@bhta.com