On 15 January 2025, the MHRA (Medicines & Healthcare products Regulatory Agency) released a new guidance on PMS requirements for medical devices following the adoption of United Kingdom Medical Devices Post-market Surveillance (PMS) Requirements Regulations in December 2024.
The Regulations apply to Great Britain (England, Wales, and Scotland), while medical devices placed on the market or put into service in Northern Ireland must follow the post market surveillance provisions of the EU Medical Devices Regulations (MDR and IVDR).
Main changes introduced to post-market requirements in Great Britain
Some of the key amendments introduced include:
- Definition of the post-market surveillance period
- Clarification of reportable side-effects
- Inclusion of self-administered treatments
- Mandatory PMS plan
- Inclusion of patient and public engagement in feedback
- Notification of preventive and corrective actions
- Approved body review of corrective and preventive actions (CAPA)
- Provision of PMS reports to MHRA
- Timing for PMSR preparation and updates
- Standardised format for PSURs
- Submission of PSURs to approved bodies
Tools for manufacturers to navigate the new PMS provisions
The MHRA published a guidance on the interpretation of certain PMS requirements. The document provides clarifications on important terms, requirements of the manufacturers PMS system, notification requirements, and reporting under the Medical Devices Vigilance System.
In addition, MDlaw libraries of documents dedicated to medical devices and IVDs placed on the UK market provide guidelines and information on the UK Regulations.
Do you have questions on compliance of medical devices and IVDs in the UK? Contact us here or write an email to MDlaw@obelis.net.
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