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REVISION of IVD DIRECTIVE Regulation instead of Directive

REVISION of IVD DIRECTIVE Regulation instead of Directive. Revision of IVD Directive Key Points. IVD Directive remains an independent legal text New Legal instrument will be a Regulation, not a Directive GHTF classification will be adopted

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REVISION of IVD DIRECTIVE Regulation instead of Directive

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  1. REVISION of IVD DIRECTIVERegulation instead of Directive

  2. Revision of IVD Directive Key Points • IVD Directive remains an independent legal text • New Legal instrument will be a Regulation, not a Directive • GHTF classification will be adopted • Conformity routes will be adapted to follow GHTF proposals for IVDs • Clinical Evidence requirements will be introduced

  3. Specific Points for IVDs • Regulation of in house assays will be tightened • Genetic tests, point of care devices, IVD software and companion diagnostics may all see specific provisions • Revision of essential requirements to update them with regards to the current legislation. Updating in particular requirements with regards to electronic and other means of distribution of IFU, use of biological substances and of hazardous substances

  4. Horizontal issues • Provisions regarding notified bodies, both in regards to their designation, their competence and the oversight of authorities will be tightened significantly • Other economic operators (Distributors, importers etc) will also be regulated • Role of Authorized representatives will be more clearly specified • Vigilance procedures will be updated • Unique device identification will be put in place

  5. Timeline for Revision of IVD Directive Aug 2008 2010 2012 2Q 2014 - 15 2017 - 18 Impact assessment Today EU Commission: MDD Recast Consultation EU Commission: IVDD Revision Consultation EU Commission: Draft Proposal National authorities: Implementation EU Parliament & Council: Legislative Approval EU Commission & Court of Justice: Surveillance and enforcement

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