Lord Cryer (Lab)

My Lords, I am grateful to be here to debate these important regulations, which herald a much-needed shift in the way we manage medical devices in Britain. This draft statutory instrument represents the first step in a series of amendments that will be introduced in the near and medium term to reform the Medical Devices Regulations 2002 to enhance the safety of medical devices, ensure availability for patients and support innovation. To give one example—the most obvious one—the 2020 Independent Medicines and Medical Devices Safety Review, led by the noble Baroness, Lady Cumberlege, revealed the shocking experiences of patients with implanted pelvic mesh, which caused intense suffering to thousands of women. Their lives have been irrevocably changed and we must act on the lessons learned in the noble Baroness’s report. The review made it abundantly clear that, to keep patients safe, substantial reforms were needed to enable the Medicines and Healthcare products Regulatory Agency—the MHRA—to effectively regulate medical devices. Post-market surveillance, or PMS, is vital for patient safety. PMS refers to the activities that manufacturers conduct to collect and evaluate the experience gained from their devices in real-world use. The MHRA provides regulatory oversight of this process to ensure that safety issues are identified and addressed promptly. Historically, the Medical Devices Regulations have provided only limited provisions for PMS, with guidance covering the detail. Although many manufacturers perform PMS to not just an appropriate but a very high standard, this is not universal. Bringing these requirements into legislation will ensure clarity, level the playing field for manufacturers and, crucially, improve data quality reported to the MHRA, reducing the risk of safety failures. This statutory instrument is necessary to improve the ability of both manufacturers and the MHRA to identify issues with medical devices and take timely action. It delivers patient benefits in three key areas. First, it improves patient safety. This instrument will enable not only the MHRA but the whole health system to better protect patients by more closely monitoring the safety and performance of devices within the NHS and in local communities. This will result in more rapid identification, investigation and resolution of safety issues, allowing the NHS to focus resource effectively. The review led by the noble Baroness, Lady Cumberlege, reported that patients felt unheard and their concerns were often dismissed. These regulations will strengthen the patient voice by requiring manufacturers to undertake patient and public engagement during their PMS activities and monitoring. Secondly, this instrument will support more rapid access for the NHS and patients to transformative—I hope—technologies. These measures provide stronger assurance that products on the market are safe and effective, which will support the implementation of new routes to market. For example, this instrument will help support the introduction of an international reliance framework as part of future medical devices regulatory reform. Finally, this instrument will support innovation. The collection of real-world data can highlight opportunities for manufacturers to refine and improve devices. This process will result in more user-friendly and effective innovations, ultimately achieving better outcomes.