A new post-market surveillance regime for medical devices
The UK is currently updating and reforming its medical devices regulations, following an extensive review and consultation process. This process aims to introduce a modern system, offering improved safety and transparency, a strong environment for innovation and alignment with international best practice.
The first piece of draft legislation in implementing this reform is now before Parliament. This addresses what was seen as the most pressing aspect of the overall package following the Independent Medicines and Medical Devices Safety (IMMDS) review - post-market surveillance (PMS). It will introduce amendments to the current medical devices regulations to set out a new PMS framework for England, Scotland and Wales. (In Northern Ireland, EU legislation – the EU Medical Devices Regulation 2017/745 and the EU in vitro Diagnostic Medical Devices Regulation 2017/746 - applies.)
The legislation will bring in clear, risk-proportionate requirements, to improve the traceability of incidents and reporting trends. A further aim is to support innovation, with the collection of real-world data helping manufacturers to improve existing products.
Under current rules, manufacturers are required to maintain a PMS system for many devices. However, the detail is covered in guidance rather than legislation. This has led to inconsistencies in the way manufacturers carry out their PMS activities which impacts the quality of adverse incident data reported to the MHRA.
The key 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
• clearer obligations on manufacturers to consider conducting a Field Safety Corrective Action (FSCA) to prevent or reduce the risk of a further serious incident, and detailed requirements relating to Field Safety Notices (FSN)
• more stringent requirements for manufacturers to conduct periodic reviews of PMS data, including for implantable devices, in order to enable earlier detection of trends/signals that may have an impact on safety.
The changes will take effect six months following final approval of the regulations, currently expected to be summer 2025. The MHRA will publish guidance ahead of this to support manufacturers in achieving compliance. This is expected to include more detail on processes for gathering real-world data and time frames for responding to requests for information.