The UK Medicines and Healthcare products Regulatory Agency (MHRA) is set to implement new post-market surveillance (PMS) regulations for medical devices in Great Britain starting on June 16, 2025. On January 15, the MHRA published guidance to assist medtech manufacturers in understanding these regulations, which include notification requirements for incidents and actions to be taken after a device’s approval. Manufacturers are encouraged to familiarise themselves with the guidance as soon as possible.
The Medical Devices (Post Surveillance Requirements) (Amendment) Regulations 2024 was presented to the UK Parliament on December 16, 2024 (Statutory Instrument 1368). PMS serves as a crucial foundational element being established by the MHRA for the upcoming regulatory framework for medical devices in Great Britain. This will be succeeded by a pre-market statutory instrument, which will be shaped by insights gained from a consultation that closed on January 5. Among other topics, this consultation focused on the recognition of device approvals granted by regulators in countries with comparable standards.
The MHRA is focusing on a post-market safety framework, assuming that approvals from reputable overseas regulators will complement UK regulations. This makes PMS crucial for safe regulation. New requirements include enhanced data collection, shorter timelines for reporting serious incidents, and improved summary reporting to quickly identify safety issues. The MHRA outlines key changes and their impact in a summary table, emphasizing clearer obligations for risk mitigation and communication to safeguard patients and users.
Northern Ireland adheres to EU medical device regulations for PMS, with notable differences compared to Great Britain. These differences include how serious incidents are investigated and reported, the preparation of PMS reports, field safety actions, trend reporting, and documentation retention. Great Britain is likely to identify more potential failures due to broader definitions of ‘incident’ and ‘serious incident’ compared to the EU.
Source: Medtech Insight (an Informa product)