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European Union › Medical Devices › Transparency

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Akin Gump Strauss Hauer & Feld LLP

EU Ratifies Pioneering Artificial Intelligence Legislation

Akin Gump Strauss Hauer & Feld LLP on

On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Sheppard Mullin Richter & Hampton LLP

FDA Joins Other Regulators in Focus on AI and Machine Learning

Sheppard Mullin Richter & Hampton LLP on

The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more

King & Spalding

EU Sets Global Standard with First Ever Artificial Intelligence Act

King & Spalding on

EU Regulation on Artificial Intelligence - On April 21, 2021 the European Commission published its Proposal for a Regulation on Artificial Intelligence, the first ever legal framework on AI. With its Proposal the European...more

Jones Day

EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746, Pharmaceutical & Medical Device Update, Vol....

Jones Day on

Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the Official Journal of the...more

Butler Snow LLP

Pro Te: Solutio - Vol.9 No.3 – Fall 2016

Butler Snow LLP on

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

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