MDSS is pleased to share that Statutory Instrument 2024 No. 1368 – The Medical Devices (Post-market Surveillance Requirements) Regulations 2024 has been published in the United Kingdom on 16 December 2024 and will enter into force on 16 June 2025.
These new regulations introduce several significant changes to the post-market surveillance obligations for medical device manufacturers. Among others, key updates include:
- Shortened reporting timelines: Manufacturers must now report incidents involving anticipated serious deterioration in health within 15 days (reduced from the previous 30-day window).
- Post Market Surveillance Reports (PMSR): The first PMSR must be prepared in accordance with the new timing requirements and updated at least every 3 years thereafter.
- Rapid information submission: Manufacturers must provide the MHRA with any information requested relating to an ongoing incident investigation or Field Safety Corrective Action (FSCA) within 3 working days.
The full text of the regulation can be accessed here: UK SI 2024 No.1368
MDSS strongly recommends that all manufacturers review and update their internal procedures to ensure full compliance with these requirements by the effective date, June 16, 2025.
Should any further information or assistance be required, please do not hesitate to contact MDSS. We are here to support through this transition.
