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Results: 1-10 of 12

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

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

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

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”

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

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

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

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

The first reference to the ECJ on the new Community regulatory data protection regime for medicinal products

  • Bird & Bird
  • -
  • European Union
  • -
  • February 28 2008

The reform of European Community legislation as to medicinal products for human use by Directive 200427EC as from November 2005 changed certain aspects of the regulatory data protection regime for such products and prevents an applicant for a generic authorisation relying on the clinical data filed by the originator for a certain period

EDPS clarifies traceability and anonymity concepts in the context of human organ transplants

  • Hogan Lovells
  • -
  • European Union
  • -
  • April 15 2009

On March 5, 2009, the European Data Protection Supervisor (EDPS) issued an opinion on the directive proposed by the European Parliament and Council on December 8, 2008, which intends to put in place an EU-wide organ donation and transplantation scheme

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