Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the quality of medical devices being delivered to the NHS; and if he will make a statement.

The Government is committed to the safe and effective regulation of medical devices in the United Kingdom; we continue to strengthen safety while ensuring patients and the public have fast access to new, innovative devices.

All medical devices placed on the UK market must comply with the European Union Medical Devices Directive 93/42/EEC (MDD). The CE mark for a device is placed on a product by a manufacturer to attest to its compliance with the safety, quality and performance requirements of the MDD, before it can be placed on the market, which includes supply to the National Health Service.

Once a device is placed on the market, the manufacturer is required to continually monitor the performance of their device, submit vigilance reports to the Medicines and Healthcare products Regulatory Agency (MHRA) when incidents occur involving their device and take appropriate safety action when required. Additionally, the MHRA monitors adverse incident reported though the Yellow Card reporting system. Adverse incident reports can be submitted to the MHRA by members of the public, healthcare professionals and the device manufacturer.

Furthermore, the new EU Medical Devices Regulation 2017/745 (MDR), which entered into force in May 2017, have introduced more stringent requirements from manufacturers to ensure a high level of patient safety. These include increased scrutiny by notified bodies, particularly for higher risk devices, new standards for clinical evidence and more rigorous vigilance reporting requirements.