The Medical Devices (Amendment) (Great Britain) Regulations 2025
The Medical Devices (Amendment) (Great Britain) Regulations 2025 amend the 2002 Medical Devices Regulations by removing specific revocation dates for assimilated EU laws.
This action maintains the existing regulatory framework for medical devices in Great Britain, ensuring public health safety, by removing now unnecessary dates for the revocation of several EU regulations.
The regulations came into force on May 24, 2025, applying to England, Wales, and Scotland.
Arguments For
Improved Regulatory Alignment: Removing outdated revocation dates in the Medical Devices Regulations 2002 streamlines the regulatory framework, potentially reducing administrative burdens and improving clarity for manufacturers and healthcare providers.
Enhanced Public Health Protection: By maintaining existing regulations, the amendment helps ensure the continued safety and efficacy of medical devices available in Great Britain.
Efficient Regulatory Processes: The removal of irrelevant revocation dates simplifies the regulatory landscape, thereby promoting ease of compliance and fostering a more efficient environment for the medical device industry.
Legal Certainty: The amendment clarifies the status of retained EU law related to medical devices, providing greater legal certainty for stakeholders and reducing ambiguity in the regulatory approach.
Arguments Against
Potential for Unintended Consequences: While aiming for simplification, alterations to the existing framework could, despite intentions, inadvertently lead to unforeseen complications or challenges in its practical application.
Limited Consultation Feedback: The level of public consultation may not fully capture the nuances of the industry's experiences or concerns regarding regulatory changes, potentially leading to oversight of specific challenges.
Resource Allocation Impacts: Streamlining regulations may still require a reallocation of resources by regulatory bodies or medical device manufacturers for adaptation and compliance, generating indirect economic impacts.
Limited Long-Term Impact Assessment: A lack of a full impact assessment may pose challenges regarding the long-term implications for healthcare professionals, patients, and the various sectors involved in the medical devices ecosystem.
- Citation, commencement, extent and application (1) These Regulations may be cited as the Medical Devices (Amendment) (Great Britain) Regulations 2025. (2) These Regulations come into force on 24th May 2025. (3) These Regulations extend to England and Wales, Scotland and Northern Ireland, and apply in relation to England, Wales and Scotland only.
This section provides the official title, effective date (May 24, 2025), and geographical scope of the regulations.
The regulations apply across Great Britain (England, Scotland, and Wales).
- Amendment to the Medical Devices Regulations 2002 (1) The Medical Devices Regulations 2002 are amended as follows. (2) Omit— (a) regulation 4H (revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date), (b) regulation 4J (revocation of Commission Regulation (EU) No 207/2012 on 26th May 2025), (c) regulation 4K (revocation of Regulation (EU) No 722/2012 on 26th May 2025) and (d) regulation 4L (revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date).
This section details the amendment to the 2002 Medical Devices Regulations.
Specifically, it removes four regulations (4H, 4J, 4K, and 4L) that set revocation dates for various EU Commission decisions and regulations related to medical devices.
These dates are now effectively removed from the 2002 regulations.
Explanatory Note (This note is not part of the Regulations) These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) by removing the 25th and 26th May 2025 revocation dates of the following pieces of assimilated EU law— • Commission Decision 2002/364 (on common technical specifications for in vitro medical devices), • Commission Regulation (EU) No 207/2012 (on electronic instructions for use of medical devices), • Regulation (EU) No 722/2012 (concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin) and • Regulation (EU) No 920/2013 (on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices). The 2002 Regulations were made under section 2(2) of the European Communities Act 1972 to implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC. A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen. The explanatory memorandum is published alongside this instrument at www.legislation.gov.uk
The explanatory note clarifies that the amendment removes specific revocation dates from the 2002 Regulations, maintaining regulations related to medical devices that were initially implemented through EU directives.
The note also states that a full impact assessment was not conducted because of anticipated minimal impact on various sectors.