MHRA Proposes 2024 Updates to Post-Market Surveillance
August 2023
On the 26 July 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) notified the World Trade Organization organization (WTO) of a draft Statutory Instrument that will potentially change post- market surveillance requirements in the UK. The changes include:
– Detail on what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers.
– Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner.
– More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices. This aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device.
There will be a 60 day period for comments. Entry into force is expected to be mid- 2024.