Just 7 months after the expiry of the Brexit transition period, the Medicines and Healthcare products Regulatory Agency (“MHRA”), the UK regulator overseeing medical devices (amongst other areas), has set in motion a consultative process aimed at updating the current UK legal framework relating to medical devices, which promises to “prioritise patient safety while fostering innovation”. The Medicines and Medical Devices Act 2021 (available here) empowers the MHRA to amend The Medical Devices Regulations 2002 (accessible here) (“MDR”), which currently govern medical devices in the UK.
While the post-Brexit implications that we highlighted in our earlier article (here) continue to apply and the new EU Medical Devices Regulation (2017/745) and EU in vitro Diagnostic Medical Devices Regulation (2017/746) have not been incorporated into UK law, since the post-Brexit transition period had passed, this development signals a potential departure by the MDR from the EU-based regime retained in the UK law pre-Brexit. As the Secretary of State for Health and Social Care (“Secretary of State”) notes in the foreword to the consultation documents, “… [the UK’s] departure from the European Union has provided us with a newfound regulatory freedom and a unique chance to reshape our rules”.
On 16 September, the MHRA published a call for views relating to the future regulation of medical devices in the UK (see here), inviting a broad range of stakeholders (including manufacturers, suppliers, healthcare professionals, patients and the broader public) to provide their insights on the UK’s future approach to medical device regulation, which is anticipated to come into force by 1 July 2023 (with appropriate transitional arrangements), which is the latest point in time by when CE-marked devices currently placed on the Great Britain market will require the new UKCA marking.
Broadly speaking, it is intended that the new, innovative regulatory regime could boost the UK medical device sector in a number of ways, including:
- creating new access pathways to support innovations – it is envisaged that the UK remains an attractive jurisdiction to launch new medical devices with approval processes that avoid unnecessary repeat assessments and which make provision for early patient access to novel treatments whilst maintaining robust safety standards;
- innovative regulation of software and artificial intelligence as medical devices – the new regulatory regime aims to be cutting edge in the software/digital and AI sectors, with regulations and guidance catering specifically to the nuances brought about by these categories of ever-evolving technology, including specific regulation of distance selling, classification of software as devices, cyber security, etc.;
- rethinking in vitro diagnostics (IVD) regulation – further to the key role that IVDs have had during the COVID-19 pandemic, the updated regulatory regime will aim to relook at how classification of IVDs should be approached bearing in mind an extended patient risk review, as well as exploring how genetic testing and companion diagnostics are addressed in future; and
- sustainability – the new regime envisages an innovative approach to sustainability by exploring the safe re-use and re-manufacture of medical devices, reducing single-use medical devices and improving supply chain resilience.
The consultation process (accessible here) takes the form of various questions posed to the participants under a number of different areas, including: scope of the new regulatory regime and classification of medical devices; economic operators, registration of medical devices and Unique Device Identification (UDI); clinical investigations and performance studies; post-marketing surveillance and vigilance; IVDs; software as medical devices; implantable devices; environmental sustainability and public health impacts; routes to market; etc. There are also specific questions intended to be targeted at the general public, rather than subject matter experts.
One particular focus area we have seen in practice is the proliferation of the digitalisation of healthcare, including software and AI as medical devices. In this regard, the Secretary of State makes the following encouraging remarks: “We also have a unique chance to build on the enormous leaps in software and artificial intelligence (AI) which we know have the capacity to transform healthcare for the better in the years ahead, through quicker diagnostics, faster treatments and better tools for clinicians. We must shape the smart regulation that helps us achieve this, and give clear guidance that ensures patient safety”.
The consultation process closes on 25 November 2021. Please contact us should you require any further information or assistance in this regard.