European Commission proposes to up-classify certain beauty equipment falling within EU Medical Devices Regulation
Read our summary on the proposed up-classification of certain products falling within EU Medical Devices Regulation.
Productwise Bitesize brings you a short introduction to the In Vitro Diagnostic Medical Devices Regulation. Since 26 May 2022, this regulation has been applicable to IVDs, and their manufacturers, importers, distributors and online sales at a distance.
The growth of digital health technologies and artificial intelligence raises novel risks, including data protection and cybersecurity risks, and key questions about the liability of services and software as a product remain unanswered. Wearables are blurring the line between consumer technology and medical devices, and consumer health data has the […]
The online sale of products is under increasing regulatory scrutiny, and the EU’s recently announced draft Digital Services Package promises to alter how online platforms and those who sell through them do business. Join Cooley’s international products law team for the next event in its webinar series, which will feature […]
Preparing your business for international trade and product safety & compliance legislation changes come January 1. The reality of the most significant shake-up of UK trade in living memory is fast approaching. Come January 1, 2021, businesses manufacturing, importing and distributing products in the UK will be subject to a […]
UK’s medicines and medical devices regulator to tackle Brexit, technological advancements and regulatory challenges (including from COVID-19) in 2020 and 2021
The MHRA has established five strategic goals for 2020-21 that will impact all those operating in the UK medicines and medical devices industries
Cooley’s international products law team are pleased to announce the fifth event in its webinar series, together with experts from Compliance & Risks and Ramboll. As an area of major regulatory and business change for product manufacturers, suppliers and other stakeholders, we anticipate the impact of the move towards the […]
COVID-19: Weekly Life Sciences Digest – International Collaboration and Adjusted Exports/Import Rules
With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.