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Healthcare & Life Sciences

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Delay of MDR Implementation and its Implications for Brexit The recent postponement of the Medical Device Regulation 2017/745 (“MDR”) means its full application will now fall beyond the end of the Brexit transition period. This could have a huge impact on the UK’s legal framework for medical device regulation after Brexit. Background The MDR repeals the existing Medical Device Directive 94/32/EEC (“MDD”). The MDR came into force on 25 May 2017, and originally, approved medical…

Are you developing a digital health solution with cross-border reach? Whether your company is new to the digital health space, or enhancing its existing digital health offering in response to COVID‑19, we’ve got you covered on the top legal issues. Take a look at our survey covering key markets like the UK, France, Germany, Italy, Russia and Spain. COVID‑19 is accelerating the adoption of digital health solutions by hospitals and medical institutions around the world.…

NHS AI Lab has released a short buyer’s checklist to guide organisations through procuring AI solutions. It’s been published in light of COVID-19 – the pandemic presents a huge opportunity to accelerate the uptake of innovative digital solutions at scale. In the UK, healthcare organisations are receiving multiple proposals for AI healthcare applications. This could ease the burden on hospitals facing enormous demands on time and clinical resource. The guide focuses on providing assurance that…

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. The Standard is in draft form at the moment, and NHSX are seeking feedback via a short survey until 22 April (although…