The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has taken decisive action to ensure regulatory stability for medical devices by eliminating the revocation dates of four assimilated European Union (EU) laws. This strategic move secures the continuity of existing regulations within Great Britain (GB) until the establishment of updated UK-specific legislation. The decision, formalized through Statutory Instrument No. 591, underscores the MHRA’s commitment to maintaining high standards in medical device regulation post-Brexit.
Key Amendments Introduced
On May 23, 2025, the UK government enacted Statutory Instrument No. 591, which amends the Medical Devices Regulations 2002 (UK MDR 2002). This amendment specifically removes the previously set revocation dates of May 26, 2025, for four critical EU regulations: Commission Decision 2002/364 on in vitro diagnostic medical devices specifications, Commission Regulation (EU) No 207/2012 on electronic instructions for medical devices, Regulation (EU) No 722/2012 concerning requirements for medical devices using animal tissues, and Regulation (EU) No 920/2013 on the supervision of approved bodies. By doing so, these regulations remain integral to GB’s medical device framework beyond their originally planned expiration.
Implications for the Medical Device Industry
The removal of revocation dates serves to prevent any potential gaps in the regulatory landscape, thereby safeguarding patient safety and ensuring that medical device manufacturers continue to operate under a stable set of guidelines. This proactive measure by the MHRA reassures stakeholders in the healthcare sector that the transition to new UK-specific regulations will be smooth and without disruption to ongoing compliance requirements. Additionally, the alignment with post-marketing surveillance regulations, such as the recently introduced Post-Market Surveillance Requirements (SI 2024 No. 1368), further strengthens the regulatory oversight of medical devices in the UK.
• Ensures uninterrupted regulatory compliance for medical device manufacturers
• Mitigates risks associated with regulatory voids post-Brexit
• Supports the seamless transition to forthcoming UK-specific medical device laws
• Enhances patient safety through continued adherence to established EU standards
Maintaining these assimilated EU laws as part of the UK regulatory framework is a strategic interim solution. It not only provides the necessary time for developing comprehensive UK-specific regulations but also maintains the high standards of medical device safety and efficacy that have been upheld under EU directives. Industry players can focus on adapting to new regulations without the pressure of immediate legislative changes, fostering a more conducive environment for innovation and compliance.
The MHRA’s decision highlights a balanced approach to regulatory governance, ensuring that patient safety remains paramount while allowing sufficient time for the legislative process to catch up with the evolving medical device landscape. This approach not only stabilizes the current market conditions but also builds confidence among healthcare providers and patients regarding the safety and reliability of medical devices available in the GB market.
Looking ahead, medical device manufacturers and stakeholders should stay informed about the upcoming UK medical device framework. Proactive engagement with the MHRA and participation in consultations can help shape future regulations, ensuring that they are robust and aligned with both national priorities and international best practices. By doing so, the industry can continue to thrive in a regulated yet innovative environment.
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