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Results: 1-10 of 5,341

France Simplifies Local Medical Device Regulations and Sets Precedent for Other Member States
  • Jones Day
  • European Union, France
  • May 23 2018

On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016


Vanessa’s Law
  • Smart & Biggar/Fetherstonhaugh
  • Canada
  • May 23 2018

This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously


Congress Continues Push on Medical Device Cybersecurity Mandates
  • Holland & Knight LLP
  • USA
  • May 21 2018

Cybersecurity risks to the health and medical device sector continue to be front and center both in Congress and the executive branch, with increasing


The Italian Supreme Court rules on the liability of broadcasters for unlawful advertising of medical devices
  • Hogan Lovells
  • Italy
  • May 17 2018

By decision No. 10892 published on 7 May 2018, the Italian Supreme Court ruled on an appeal brought by the Ministry of Health against a decision of


Clinical trials in Romania
  • Maravela & Asociații
  • Romania, Global
  • May 16 2018

A structured guide to clinical trials in Romania


Health Care : Helpful Hints - May 2018
  • Burr & Forman LLP
  • USA
  • May 15 2018

The Office of Inspector General (“OIG”) approved a proposed arrangement involving medical devicessupplies. OIG Advisory Opinion No. 18-02 concerns an


Netherlands sunshine rules for medical devices - submission deadline 1 June 2018
  • Hogan Lovells
  • Netherlands
  • May 15 2018

Based on the self-regulatory Code for medical devices (GMH Code) all financial relations between all medical device suppliers and all medical


Federal Court declares invalid patent for medical device measuring osmolarity of tear film
  • Smart & Biggar/Fetherstonhaugh
  • Canada
  • May 14 2018

The Federal Court recently found certain claims of a patent relating to a chip for measuring the osmolarity of a sample of bodily fluid, including tear film, invalid on the basis of obviousness and anticipation. The court agreed with the claim construction urged by the plaintiffs, finding that the claims encompassed both in vivo and ex vivo applications of the invention. Thus, the defendant's competing medical device - which measured osmolarity in vivo - fell within the scope of the claims


Clouded judgment: when is software regulated as a medical device?
  • DAC Beachcroft
  • United Kingdom, European Union
  • May 14 2018

Technology is revolutionising medicine and software is increasingly used in healthcare to help both patients and clinicians in their decisions. But


FDA’s Medical Device Safety Action Plan
  • Crowell & Moring LLP
  • USA
  • May 8 2018

On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to