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<p>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.</p><p> </p><p>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.</p><p> </p><p>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.</p><p> </p><p>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.</p>
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