Calling all Medical Device Manufacturers: New Rules on Post-Market Surveillance to Take Effect
On 16 May 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance for medical device manufacturers on the changed requirements for post-market surveillance (PMS) with instructions on using the digital platform, the Manufacturer's Online Reporting Environment (MORE), to report serious safety incidents and field safety corrective actions (see Medical devices: post-market surveillance and Manufacturer’s Online Reporting Environment).
In 2024 the government passed The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 which amend the UK Medical Devices Regulations 2002 (MDR) by adding the new Part 4A on PMS requirements for medical devices. The changes include updated notification requirements for incidents/adverse events, as well as increased reporting of preventive and corrective measures taking place after a device is approved for the GB market. The objective behind these changes is to enable the regulator to identify patterns or trends that could reveal safety concerns more efficiently.
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Subscribe nowThe new regulations take effect on 16 June 2025, but manufacturers have several months to update their systems – manufacturers must start using the new scheme to report incidents on MORE by no later than 16 October 2025.
Who does this impact?
- The new rules apply to manufacturers placing medical devices on the market in Great Britain (England, Wales, and Scotland) or those reporting on behalf of manufacturers. The new PMS requirements apply whether the manufacturer is based in Great Britain (and/or has a local entity) or is based outside Great Britain and has appointed a UK Responsible Person (UKRP).
- Medical device manufacturers placing products on the market in Northern Ireland (and their Authorised Representatives) must continue to follow the PMS rules as set out in the EU Medical Device Regulations, using the electronic system Eudamed for reporting. However, as the MHRA is the competent authority for Northern Ireland, manufacturers must still report serious incidents, field safety corrective actions and trends to the MHRA.
- Patients, healthcare professionals, and other medical device users will continue to submit any data related to adverse events via the Yellow Card reporting for medical devices.
What is required?
- Medical device manufacturers and/or their representatives (including UKRPs in Great Britain and Authorised Representatives in Northern Ireland) need to register for a MORE account.
- In early June, the MHRA will release updated guidance on submitting information on manufacturer incident reports as well as field safety corrective actions.
- From 16 June 2025, manufacturers will be able to submit their PMS data via the new scheme on MORE. Manufacturers must start using the new scheme to report incidents to MORE no later than 16 October 2025.
Medical device manufacturers must now update their procedures to ensure compliance with the changed PMS obligations and reporting methodology.
If you need assistance navigating the new PMS requirements or would like to discuss any of the issues raised in this blog, please contact Taly Dvorkis.
The content of this blog and its related materials does not constitute legal advice and is provided for general information purposes only. Specific legal advice should be sought before taking any actions based on the content of this blog.
