European Commission Will Revise IVD Guideline

On its webpage, the European Commission published a public consultation on the In-Vitro Diagnostic Medical Devices Directive (IVD) 98/79/EC. Within the framework of a public consultation on the revision of the other two directives on medical devices (90/385/EEC and 93/42/EEC) in 2008, the European Commission recognised the need to revise the IVD Directive as well. With the revision, the directive is meant to be adapted to the changes made to the other two directives on medical devices; but it is also planned to update it to the state of the art. In this context, the guidelines of the Global Harmonisation Task Force (GHTF) are mentioned explicitly.

This public consultation regarding the revision of the IVD Directive is conducted by means of a 9-page questionnaire available on the webpage of the European Commission's Directorate General Health and Consumers (SANCO). It is the aim of this public consultation to identify possible improvements on the basis of the input and, of course, to collect data on the socio-economic impact of the changes (protection of health, competitiveness, innovative force).

The questionnaire encompasses a total of 5 blocks of questions from completely different areas. The block of questions titled "Classification" of IVDs includes e.g. the question whether a risk-based classification system according to GHTF would be considered to be a useful replacement of Appendix II of the IVD Directive. Another battery of questions deals with the "Conformity Assessment Procedure". Here, too, it is asked whether it would make sense to adapt the IVD Directive to the GHTF guideline on conformity procedures. Other questions concern the "Scope" (questions regarding in-house tests and genetic tests), the "Clinical Evidence" (clinical validity and usefulness) and "Others" (conditional CE marking, companion IVDs).

On balance one can say that the medical device environment is still in progress. After revising the directives for the active, implantable medical devices and the medical devices themselves, the European Commission is now dealing with the IVD Directive. The planned inclusion of GHTF guidelines will probably turn out to be very useful.

Comments can be submitted until 15 September. The questionnaire can be found here.

Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

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