On 26/02/2025, the UK government published its response to the public consultation on proposed amendments to the Medical Devices Regulations 2002 concerning four specific pieces of assimilated EU law. The consultation, which ran from 14 November 2024 to 5 January 2025, received 287 responses. These responses came from various stakeholders, including manufacturers, healthcare professionals, and trade associations.
Key decision: retaining assimilated EU law to ensure continuity
A significant outcome of the consultation is the proposal to remove the “sunset date” (end date of applicability) of four pieces of assimilated EU law that were set to expire on 26 May 2025. This move ensures continuity in the regulatory framework and prevents disruption to market access and patient safety. These four pieces of assimilated EU law were set to expire on 26 May 2025. This move ensures continuity in the regulatory framework and prevents disruption to market access and patient safety. The four retained regulations include:
- Commission Decision 2002/364: Common technical specifications for in vitro diagnostic medical devices (IVDs).
- Commission Regulation (EU) No 207/2012: Electronic instructions for use of medical devices.
- Regulation (EU) No 722/2012: Requirements for medical devices manufactured using animal tissues.
- Regulation (EU) No 920/2013: Designation and supervision of approved bodies.
Industry response: strong support for stability
The proposal to retain these regulations was met with the support of 83% of respondents. The Medicines and Healthcare products Regulatory Agency (MHRA) cited the importance of maintaining regulatory certainty and ensuring patient safety as the primary reason while the UK develops its updated medical device regulations. Some respondents emphasised the need for future updates to these regulations. Others requested additional guidance, particularly regarding electronic instructions for use and common technical specifications.
Next steps: transition towards a new UK framework
The government confirmed that these assimilated laws will not remain indefinitely. They serve as a temporary measure until the new UK regulatory framework is implemented. The ‘Pre-Market’ regulations, expected in 2026, will introduce updates, including replacing the reference to Commission Regulation (EU) No 207/2012 with Implementing Regulation (EU) 2021/2226. Further consultations on common technical specifications and high-risk IVDs are also in progress, with responses expected soon.
The UK government will draft and enact the necessary secondary legislation as soon as Parliamentary time allows, with further responses on additional consultation proposals to follow.
For manufacturers, this decision provides much-needed regulatory stability, ensuring ongoing market access while the UK develops its independent medical device framework.
Do you have questions on compliance of medical devices and IVDs in the UK? Contact us here.
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