‘NoBoCap’ EU4Health Funded Program: Initiatives to Support SMEs & Training Courses
18 March 2025
March “In All Other News”: EC Rep Symbol Revised, Article 10a Flowchart, EHDS Regulation, and more
2 April 2025Background
The MHRA’s new Post-Market Surveillance (PMS) requirements go into effect in less than three months: Monday, 16 June 2025.
The new PMS regulation is applicable to Great Britain (England, Scotland, Wales), and introduces changes such as:
- revised timeframes to report serious incidents,
- a requirement to implement a PMS system that proactively gathers and assesses data about the devices on the market, and
- report significant increases in the frequency or severity of incidents involving a device, if the manufacturer considers that the increase could have a significant adverse impact on the risk analysis.
For more background on UK PMS Regulation SI 2024/1368 and corresponding guidance, please read: MHRA Publishes Guidance on the New Post-Market Surveillance (PMS) Regulation
Link to Templates
Casus is making available free, Word format (i.e., easily editable) PMS Procedure and Plan templates for download. To access these, please visit: UK Post-Market Surveillance (PMS) Templates
