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MHRA — Draft Medical Devices Regulations 2026

Last Updated on 28/05/2026 by Samantha Lewis

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 requests all interested stakeholders review their guidance questions for the Regulations and then fill out a survey on the impact of the Regulations by 19 June 2026. BHTA will complete the survey as well, but it is crucial MHRA hears directly from industry, especially manufacturers.  The survey and its attendant documents are at:

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:

Upcoming BHTA / AXREM webinar with MHRA

Following the survey, we are also pleased to announce a new joint AXREM/BHTA webinar featuring speakers from the MHRA, taking place on Thursday 9th July at 14:00.  The session will provide an overview of recent regulatory developments and key updates from the MHRA relevant to industry stakeholders.  Members can register here:  AXREM/BHTA Webinar – Regulatory Update: Latest Developments from the MHRA.