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Results: 1-10 of 61

Significant overhaul of EU medical devices regime planned
  • Sidley Austin LLP
  • European Union
  • October 29 2012

On 26 September 2012, the European Commission published the proposals for two new Regulations intended to replace the EU directives that govern medical devices intended to be placed on the EU market


EU court rules on classification of certain borderline products as medical devices
  • Sidley Austin LLP
  • European Union
  • December 3 2012

In a judgment published on November 22, 2012, the Court of Justice of the European Union (CJEU) confirmed that products intended for the investigation of physiological processes only fall within the scope of the EU Medical Device Directive (9342EEC), as implemented into EU Member State legislation, if the products are intended for a medical purpose


New EU cosmetics regulation published
  • Sidley Austin LLP
  • European Union
  • December 22 2009

A new EU law on cosmetic products, the Cosmetics Regulation (the Regulation), was published in the EU’s Official Journal today


European Commission proposes new rules for novel foods
  • Sidley Austin LLP
  • European Union
  • January 22 2014

The European Commission recently adopted a proposal for a new EU Regulation on novel foods, which - if adopted - will streamline and simplify the


Falsified Medicines Directive public consultation on “safety features”
  • Sidley Austin LLP
  • European Union
  • December 22 2011

The EU’s Falsified Medicines Directive (Directive 201162EU) forms part of the Pharma Package, a series of measures proposed by the European Commission in December 2008


European Parliament calls for additional medical device safety measures
  • Sidley Austin LLP
  • European Union
  • June 18 2012

On 14 June 2012, the European Parliament (“EP”) adopted a Resolution calling on EU Member States and the European Commission to introduce and implement new measures aimed at ensuring the safety of medical devices


European Commission proposes overhaul of dietetic foods regime
  • Sidley Austin LLP
  • European Union
  • August 1 2011

The European Commission adopted a proposal for a Regulation on Food Intended for Infants and Young Children and on Food for Special Medical Purposes (the “Proposed Regulation”) on June 20, 2011


New EU safety reporting guideline enters into force
  • Sidley Austin LLP
  • European Union
  • September 1 2011

As of 1 September 2011, sponsors of clinical trials must comply with the new clinical trial safety reporting requirements set out in the International Conference on Harmonisation E2F Guideline on Development Safety Update Reports


European Commission allows submission of new data in support of probiotic health claims
  • Sidley Austin LLP
  • European Union
  • June 20 2011

The European Commission has opened a four-month window, starting on June 1 and closing on September 30, 2011, during which stakeholders can submit new data to Member States in support of certain probiotic health claims rejected by the European Food Safety Authority


EU and ISO deliberating on nanotechnology labeling guidance
  • Sidley Austin LLP
  • European Union, Global
  • November 8 2010

The European Committee For Standardization (CEN) and the International Organization For Standardization (ISO) have jointly distributed for ballot and comment a document titled "Guidance on the labeling of manufactured nano-objects and products containing manufactured nano-objects," ISOTS 13830:2010