The IVD directive

David Barton and Stuart Hogarth are involved in the discussions and consultations around the review of the IVD Directive which regulates the manufacture and use of diagnostic test kits in Europe. Their focus has been to protect patient safety by ensuring that genetic tests are as safe as possible while remaining available to all who require them. High-level workshops have been organiszed and several face-to-face meetings with the European Commission have taken place. The result is a new draft Regulation which incorporates most of EuroGentest's demands and lays the foundation for mandatory accreditation for genetic testing laboratories in Europe.

• ^{! NEW} Proposed amendments to EU Regulation on Medical Devices are counter to patients’ interests and unworkable, says ESHG

• ^{! NEW} Alliance-ESHG Full Opinion on the proposed Genetics Counselling Article"
• ^{! NEW} Executive Summary of the Full Alliance-ESHG Legal Opinion

• The European Commission's proposals for new regulations for Medical Devices and IVD Medical Devices
• EuroGentest Network Response to the European Commission Proposal for a Regulation on IVD Medical Devices 
  Briefing note on the new proposal written by David Barton and Stuart Hogart 
  - Citizens' summary: EU proposals on medical devices
  - Questions and answers

• Response to the 2010 public consultation on the revision of the IVD Directive 
• IVD Directive  
• Commission opinion on external samples for in-house assays  
• European standards on IVD
• Commission site

• Workshop October 27-28, 2011
• Workshop April 24, 2007