What are the legal challenges of bringing such innovative and scalable products to the market? In this webinar, we will explore a case study on a drug-device combination product with a strong digital component. These types of products are becoming increasingly sophisticated and they raise new opportunities, but also new challenges from a legal point of view. We will discuss the legal challenges for a company bringing a digital health product to market with a specific focus…
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on medical device standalone software last month. We’ve set out our top 5 takeaways from the new guidance
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…