The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published a new roadmap setting out its timeline for an overhaul of the UK medical device regulations. The MHRA is taking a phased approach, with new legislation pencilled in for 2024 on Post Market Surveillance (PMS) and in 2025 for a wider core framework. Current plans indicate certain areas of alignment with the requirements of the EU Medical Devices Regulation (EU MDR). The MHRA further…
Manufacturers of Machine Learning-Enabled Medical Devices (MLMDs) face a key challenge: existing requirements and processes on the notification and management of ‘substantial’ and ‘significant’ changes to medical devices need adapting for MLMDs. The MHRA, together with the U.S. Food and Drug Administration (FDA) and Health Canada, has published five guiding principles on predetermined change control plans (PCCPs) to help resolve this tension. What is the tension between AI and change management for medical devices? Some…
The UK’s Information Commissioner’s Office (ICO) has launched a public consultation on its draft guidance on transparency in the health and social care sector. The proposed guidance emphasises the importance of going beyond the legal requirements of the GDPR in order to build trust with patients, and builds on themes of openness, honesty and patient engagement. The consultation is open until 7 January 2024. We’ve set out our top six takeaways on the proposed guidance…
The UK government has issued proposals for a new licensing regime for currently unregulated cosmetic procedures whilst also intending to classify and regulate certain cosmetic products such as dermal fillers as medical devices. The government has brought forward an amendment to the Health and Care Act 2022 that gives the Secretary of State for Health and Social Care the power to bring into force a licensing scheme in England for non-surgical cosmetic procedures. The purpose…
Following a consultation earlier in the year, the UK government has published draft legislation on the proposed design of a merged R&D tax relief scheme. The draft proposes that the existing schemes – the R&D expenditure credit (RDEC) and the SME R&D relief – be merged into a single scheme that would operate as an above-the-line expenditure credit (in line with the current RDEC). Given the value of R&D tax relief to the life sciences…
Last month, the UK House of Commons debated the current state of regulatory and legal hurdles negatively affecting the development of psilocybin-based (the psychedelic compound most commonly found in ‘magic mushrooms’) therapies for mental and physical health disorders in the UK. The debate resulted from an e-petition, which garnered 11,824 votes in February this year. The debate saw a consensus among Members of Parliament across party lines, collectively supporting the proposal for rescheduling psilocybin from…
We’ve set out our top ten tips on ensuring GDPR compliance if your organisation is procuring AI solutions from third parties, whether this is to train an AI imaging system, integrate AI solutions into a patient-facing app or to allow your staff to make use of generative AI. These tips are based on the issues which we see are attracting regulatory scrutiny in practice, the potential stumbling blocks we’re coming across in supplier terms, as…
On 27 April 2023, the MHRA announced that the UK government intends to introduce legislation this spring that will extend the acceptance period of CE marked devices onto the Great Britain market. The MHRA’s announcement has provided much needed. This statement made by the MHRA is an update to their announcement made on 28 March 2023, on which we previously blogged. This is a very welcome step from the MHRA after what has been a…
On 15 March 2023 (Regulation (EU) 2023/607), the EU extended both the transition period for the EU Medical Device Regulations (EU MDR) and the validity of CE mark certificates. The new arrangements give manufacturers more time than previously anticipated to get their medical devices certified and they recognise the capacity challenges faced by notified bodies. Higher-risk devices now have until 31 December 2027 to ensure that they comply with EU MDR requirements and medium to…
In its white paper published last month, the UK Government set out its principles-based, adaptive approach to regulating AI. The UK approach stands in stark contrast to the more static and prescriptive approach of the EU AI Act. Instead of assigning responsibility for AI governance to a new single regulator, the UK Government is empowering existing regulators to come up with tailored approaches for specific sectors. The aim is to ensure that the UK remains a flexible…