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• Conformity routes will be adapted to follow

GHTF proposals for IVDs• Clinical Evidence requirements will be

introduced

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

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

Timeline for Revision of IVD Directive

EU Commission: MDD Recast Consultation

EU Commission: IVDD Revision Consultation

EU Commission: Draft Proposal

EU Parliament & Council: Legislative Approval

National authorities: Implementation

Today

Aug 2008 2012 2Q

Impact assessment

2010 2014 - 15 2017 - 18

EU Commission & Court of Justice: Surveillance and enforcement