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IVDs (in vitro diagnostics) to be covered in EU vigilance document:

This article was originally published in Clinica

Executive Summary

The European Commission's medical device expert group meeting has determined that products covered by the In Vitro Diagnostics Directive should be included in the Commission's vigilance guidance document. Representatives from the Commission, member states and industry decided at their meeting last month that these products should be covered in a new appendix to the document, where the concept of indirect harm would also be addressed.

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