Document New medtech regulations Notified Bodies

Sampling of class B and C IVDs under IVD Regulation 2017/746/EU

This paper is intended for discussion with regulators and notified bodies to highlight the issue of sampling and its impact on manufacturers and the regulatory system. It makes a first proposal for an approach which could be taken, based on the legal text and on the link to the IVD Regulation nomenclature.

Posted on 06.12.2018

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