The Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on 16 September 2021 inviting views on possible changes to the regulatory framework for medical devices in the UK. The consultation is open for 10 weeks until 25 November 2021 and contains proposals for stakeholders to consider over 15 chapters, covering a broad range of topics including approved bodies, conformity assessments, clinical investigation and performance studies, and software as a medical device. The aim is to have a new regulatory regime in place by 1 July 2023.

Medical devices in the UK are currently regulated under the Medical Devices Regulations 2002 which implemented the EU Medical Devices Directives. Following the UK’s departure from the European Union, the new Medical Device Regulations 2017/745 (applicable in the EU since May 2021), which extensively updated the regulatory framework, do not apply under UK law. The consultation states that ‘the MHRA now has the opportunity to create a world-leading regime that prioritises patient safety while fostering innovation, including streamlining the approval of medical devices’, and this consultation therefore provides an opportunity to ensure that the UK will develop regulations in line with international frameworks (including the EU framework) going forward.

You can access and lend your views to the consultation process here.