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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

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”