The UK government has announced that the implementation of the future UK Medical Device Regulations will be pushed back from 1 July 2023 to 1 July 2024. The MHRA’s announcement means that CE-marked products will continue to be accepted in Great Britain and manufacturers will only be required to obtain a UK Conformity Assessed mark from July 2024. As a result, this extension will provide manufacturers an extra year to ensure that their products are compliant with the new UK regime.
The UK government has recently published its roadmap for regulating AI as a medical device (AIaMD) and software as a medical device (SaMD). This will form part of the basis of the upcoming UK Medical Device Regulation reforms in 2024. In light of the operational difficulties faced by the NHS, AIaMD and SaMD are attractive solutions to alleviate pressures on the UK health system. Yet these products are complex and require a high level of regulatory scrutiny to ensure effectiveness and protect the safety of patients.
In a draft compromise text obtained by Politico, the European Council has dropped a key provision seeking to harmonize telemedicine from the draft European Health Data Space. The (now-removed) Article 8 was aimed at encouraging the cross-border provision of telemedicine services across the EU. However, the reality is that there are vast national differences between Member States on telemedicine-related laws. It is going to require a far more concerted legislative effort to harmonize this area of law across the EU.
The draft European Health Data Space Regulation (EHDS) is flying under the radar for some industry players. It’s just one part of a tidal wave of EU data legislation coming down the track (including the Data Act, Data Governance Act and AI Act). This means it can easily get lost in the noise. But if you take a deeper look, the EHDS has some complex repercussions for a range of players; from pharma and medtech, to hospitals, public health bodies and even big tech. And not all of it is good news.
Explore Data PULSE, a platform which helps you to navigate the complex landscape of data, regulatory and IP protection concerns at each stage of the medical product life cycle. As you navigate through each key issue, Data PULSE will help you to identify and mitigate risks across multiple jurisdictions and optimize your strategy through research, market authorization and post-market study phases.
The Medicines & Healthcare products Regulatory Agency launched a consultation in early 2022 as part of its post-Brexit efforts to develop a world-class and flexible regulatory environment for clinical trials. The consultation closed in March 2022, but continues to offer insights into what the future holds for the UK regime for clinical trials.
The future of the healthcare and life sciences supply chain is digital. New technologies are redefining the delivery of healthcare, improving clinical data flows, tracking medical supply inventory and enhancing overall patient care. In this one-hour webinar, our panel of experts will look at the business issues, practical applications and legal considerations when digitizing the supply chain, covering topics such as:- The blockchain potential, Artificial intelligence and trade secrets, The cybersecurity challenges of digital transformation
NHSX has published a new data sharing agreement (DSA) template. The template is a great tool for companies collaborating with NHS organizations to access and use data for R&D, and for companies who access and use data as part of their provision of services to the NHS.
NHSX recently launched a brand new information governance portal providing a ‘one-stop shop’ for NHS policies and guidance. The new portal covers everything from GDPR in research to record management. But even with the new portal, navigating NHS guidance on data isn’t easy.
NHSX, the technology and digital unit of the UK’s National Health Service (NHS), recently published its draft Digital Health Technology Standard.
The standard aims to accelerate how digital health technologies (DHTs) are reviewed, commissioned and scaled for use across the wider health and care system, and provides guidance to support digital health technology developers.