Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, flags the regulations that herald a new Post-Market Surveillance regime for Medical Devices in the UK.
The UK Parliament is set to consider and approve new Post-Market Surveillance regulations for medical devices after the necessary Statutory Instrument [proposed text of the regulations] was laid before both Houses of the UK Parliament.
The proposed regulations are expected to come into effect in the Summer of 2025 to give suppliers time to adapt to the new rules 6 months after they are approved by Parliament.
The proposed regulations introduce new post-market surveillance requirements for medical devices and accessories to medical devices that are placed on the market or put into service in Great Britain. They require manufacturers to have a post-market surveillance system based on a post-market surveillance plan and require manufacturers to take preventive action, corrective action and field safety corrective action where problems emerge.
Intended to promote patient safety as well as providing useful data, the regulations impose investigation and reporting requirements on manufacturers for serious incidents, trends in incidents and the post-market surveillance of their devices generally. They also provide for the retention of relevant documents and for them to be provided on request to the regulator, the Medicines and Healthcare Products Regulatory Agency [MHRA].
Laura Squire, MedTech Regulatory Reform Lead and Chief Officer at the MHRA, said: “The explosion of innovation in health technology in recent years has the potential to bring transformative approaches to healthcare. These regulations will provide the necessary oversight to ensure that this progress is made as safely as possible.”
The proposed regulations cannot be amended by Parliament, only accepted in full or rejected [which is extremely unlikely to happen], so the MedTech sector should plan ahead for their adoption.
Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com