To ask the Secretary of State for Health and Social Care, how many UK-based notified bodies for medical devices have registered under the EU Medical Devices Regulations 2017; how many of those bodies were registered under previous regulations; what assessment he has made of the effect on the NHS in the event that insufficient notified bodies register; and if he will make a statement.
There are currently four United Kingdom-based notified bodies designated under the Directive 93/42/EC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices. Of these four UK notified bodies, one is also designated Directive 90/385/EEC on active implantable medical devices. The Medicines and Healthcare products Regulatory Agency (MHRA) is the designating authority in the UK and is responsible for designating and monitoring the performance of UK notified bodies. This includes undertaking regular audits of their activities.
New European Union Regulations for medical devices (Regulation 2017/745) and in vitro diagnostic medical devices (Regulation 2017/746) entered into force in May 2017, with Regulation 2017/745 fully applying from May 2020 and Regulation 2017/746 fully applying from May 2022. Each notified body will need to apply for separate designation under these Regulations. No notified body in the UK, or across the EU, is currently designated under either Regulation.
The new Regulations substantially strengthen the regulatory framework for medical devices and in vitro diagnostic devices and the MHRA recognises the importance of having competent notified bodies in place in sufficient time to ensure continuity of supply of products to the UK market.
To this end, the MHRA has been engaging with UK notified bodies on an ongoing basis to ensure that sufficient resources are in place and to ensure notified bodies are prepared for the designation process. The MHRA is also providing expert auditors to support the process of joint assessment of notified bodies under the new legislation across the EU to support the consistent application of the new Regulations across all EU Member States.