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Reed Smith (Worldwide)
On January 18 2021, the European Union Agency for Cybersecurity (ENISA) published its Cloud Security for Healthcare Services report.
Morrison & Foerster LLP
In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 ("MDR"), which will soon govern medical devices software...
Ropes & Gray LLP
The COVID-19 pandemic has transformed the business landscape across the health care and life sciences industries, and continues to do so.
Arnold & Porter
New EU rules under chemicals and waste legislation require manufacturers and suppliers of products to provide information to a centralized EU database.
Arnold & Porter
After four years of intensive discussion, on 24 December 2020, the EU and the UK reached an agreement in principle on the EU-UK Trade and Cooperation Agreement (the Agreement)...
Arnold & Porter
On 24 December 2020, the European Union and the United Kingdom reached an agreement in principle on the EU-UK Trade and Cooperation Agreement (the Agreement).
Morrison & Foerster LLP
Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law...
KTN Microbiome Strategic Roadmap is now live.
Haseltine Lake Kempner LLP
After indulging over the festive period many resolve themselves to a New Year of changes to better their health, well-being, and lifestyle.
Amongst the bad news that took up a lot of headlines last year, there was one story at the end of last year that caused a lot of excitement in the life sciences sector.
BCL Solicitors LLP
Healthcare organisations have written to the Secretary of State for Health and Social Care, pushing for the introduction of emergency legislation to protect healthcare professionals...
Julian Hitchcock, from our Life Sciences Regulatory team, highlighted the need for a public-facing inquiry at a European level that permits an analysis of what the law needs to do.
The European Commission's Medical Device Coordination Group (MDCG) recently published its guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.
Marks & Clerk
In the face of Brexit discussions, the protection of agricultural products and foodstuffs, with regards to the quality we have come to expect, remains unclear.
TÜV Rheinland (DE) has received designation as a Notified Body for the purposes of the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.
MedTech Europe, the trade association representing the medical technology industries, has reiterated calls for the EU to delay the implementation of the In Vitro Diagnostics Regulation (IVDR) (EU) (2017/746).
Hill Dickinson
Each month our Health team will update you on recent key developments, and look ahead to what's coming up in your sector.
Venner Shipley
Katherine Dainty explains how technology has created potential for plugging the data gaps in general health, improving research on female-specific conditions and improving the future of women's health.
Arnold & Porter
The UK MHRA has issued draft guidance on randomised controlled trials generating real-world evidence (RWE) that are used to support regulatory decisions.
Haseltine Lake Kempner LLP
As the development and possible approval of a vaccine for Covid-19 gathers momentum, we take a brief look at and reflect on the life of the American microbiologist...
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