Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that the (a) testing and (b) certification procedures for (i) metal and (ii) other compositions of hip replacements fitted as medical devices by the NHS ensure that such devices are safe for patients; and if he will make a statement.

All medical devices placed on the United Kingdom market must comply with the European Union Medical Devices Directive 93/42/EEC (MDD). The European Conformity (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.

For higher risk devices, including hip replacement implants, manufacturers must have the product’s safety and performance assessed by an independent certification body, called a notified body, before the CE mark can be affixed.

A notified body’s tasks will vary depending on the classification of the products concerned, but typical activities include an examination of the design dossier relating to each type of product, an assessment of the full technical information, and manufacturer inspections. Under the MDD, manufacturers are required to have clinical and safety data to support their performance claims for the device, which is also assessed by the notified body.

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 European Union Medical Devices Regulation 2017/745, which entered into force in May 2017, has 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.