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 adequacy of the number of notified bodies to service medical devices under the terms of the Medical Devices Regulation.

New European Union Regulations for medical devices (MDR) entered into force in May 2017 and will fully apply from May 2020.

The new Regulations substantially strengthen the regulatory framework for medical devices and notified bodies are having to make significant changes to meet the enhanced requirements. These changes have the aim of improving the quality, consistency and rigour of notified body assessments, which was one of the Government’s key aims for the new legislation.

Ministers have met with and received letters from industry representatives who have raised concerns about capacity in the notified body sector across the EU to support the implementation of the MDR. The Government recognises the importance of having competent notified bodies across the EU in place in sufficient time to ensure continuity of supply of products to the United Kingdom market.

For this reason, at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on 14 June, the Parliamentary Under-Secretary of State (Baroness Blackwood of North Oxford) raised the Government’s concerns about the readiness of critical infrastructure required to implement the MDR and the risk that some existing and new to market products will not be available to patients as a result.

We very much recognise the benefits of the new Regulations and the imperative of full implementation as soon as possible in the interests of patient safety. Therefore, at EPSCO the Government emphasised the importance of finding a coordinated solution at an EU level and we will continue to do what we can to influence these discussions.

In parallel with this activity, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with its notified bodies on an ongoing basis to ensure that sufficient resources are in place and notified bodies are prepared for the implementation of the new EU legislation. The MHRA is also offering a substantial amount of resource to the EU in order to support and expedite the designation process.

Through the Office for Life Sciences, the Government plans to work with stakeholders to come to a shared understanding of the issues and discuss what further mitigating action could be taken. Further engagement with industry will therefore take place in the short term.