New draft legislation was laid before the UK Parliament on 21 October 2024 which would require greater post-market surveillance (PMS) for medical devices on the market in Great Britain.
This new PMS statutory instrument (SI) is an amendment to the UK Medical Devices Regulation 2002 (UK MDR) and will bring UK medical device requirements in line with other European markets.
The key updates include the following:
- Specific requirements for the PMS systems of medical device manufacturers within the UK, such as data collection methods and data harmonisation across manufacturers
- Increased serious incident reporting obligations
- A clear list of obligations for marketers regarding field safety corrective actions (FSCAs) and field safety notices (FSNs)
- Greater obligations for marketers to review their PMS data, including for implantable medical devices (IMDs)
If passed, this legislation will have a six-month implementation period and will come into force in the summer of 2025.
The new PMS SI is intended to improve medical device safety for patients, as well as generate data on how well medical devices perform once purchased. These data can be used by both manufacturers and regulators to streamline future medical device research. While the new obligations will burden medical device manufacturers with additional costs, the newly produced harmonised data will provide important feedback to ensure manufacturers are able to target areas of improvement.
Laura Squire, the MedTech Regulatory Reform Lead and Chief Officer at the UK Medicines and Healthcare products Regulatory Agency (MHRA), said in a recent press release: ‘This legislation reflects the Government’s wider priority of improving patient safety and is the first part of the new regulatory framework coming in for medical devices.’
This amendment follows a consultation by the MHRA on medical device regulation in the UK, which received strong feedback in support of increased safety measures for patients with medical devices. On 14 November the MHRA published a new consultation, this time regarding in vitro medical devices (IVMDs), which will close on 5 January 2025.
