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.

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