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Results: 1-10 of 12

Access to clinical trial data - the irreversible process

  • Bird & Bird
  • -
  • European Union, United Kingdom
  • -
  • February 25 2013

The issue of ensuring transparency of the activities of regulators is nothing new, with public bodies being required to observe Freedom of

EDPS opinion on European Commission proposal for regulation on clinical trials on medicinal products

  • Bird & Bird
  • -
  • European Union
  • -
  • February 4 2013

The EDPS has issued an opinion on the European Commission's proposal for a Regulation on clinical trials on medicinal products for human use

How do the proposed revisions to the Medical Devices Directives impact on software?

  • CMS Cameron McKenna
  • -
  • European Union
  • -
  • November 12 2012

On 26 September, the European Commission submitted formal proposals for the revision of the Medical Devices Directives 90385EEC and 9342EEC (MDD) to the Council and European Parliament

AG opinion on medical devices qualification issues for e-health software products

  • CMS Cameron McKenna
  • -
  • European Union, Germany
  • -
  • May 21 2012

On 15 May 2012, the Advocate General published his Opinion in the European Court of Justice reference in Brain Products GmbH v BioSemi VOF and Others by the German Supreme Court (Bundesgerichtshof

Software as a medical device

  • Eversheds LLP
  • -
  • European Union
  • -
  • March 9 2012

Directive 9342EEC and Directive 90385EEC (both as amended) (Directives) each defines “medical device” to include: “Any instrument, apparatus, appliance, software, material or other article” when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device

Article 29 Working Party issues guidance on European Patients Smart Open Services

  • Hunton & Williams LLP
  • -
  • European Union
  • -
  • February 14 2012

On January 25, 2012, the Article 29 Working Party (the “Working Party”) issued a Working Document providing guidance on data protection issues relating to the European Patients Smart Open Services (“epSOS”) project

When does software become a medical device?

  • CMS Cameron McKenna
  • -
  • European Union
  • -
  • January 25 2012

The European Commission has now published guidance in the form of a MEDDEV (2.16) that will assist manufacturers and regulators in determining whether standalone software should be qualified as a medical device and therefore require CE marking under one of the Medical Devices Directives (“MDD”

New EU data protection regulation to have significant impact on life sciences

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • December 13 2011

A draft EU Regulation on Data Protection was released un-officially last week

European Medicines Agency publishes new electronic submission format of information on medicines

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • August 22 2011

The European Medicines Agency (“EMA”) has published the new electronic format in which pharmaceutical companies will need to submit information on medicinal products for human use authorized or registered in the European Union

Controlling and processing data in EU clinical trials

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • November 22 2010

The legal regime for the conduct of clinical trials of medicinal products for human use in the European Union is set out in Directive 200120EC (the Clinical Trials Directive

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