Document paper MedTech Europe New medtech regulations

IVDR – MDR Labelling differences: what symbols apply to IVDs

The Medical Devices Regulation 2017/745/EU (‘MDR’) and the In-vitro Devices Regulation 2017/746 (IVDR) both have new requirements for label and packaging of devices.
However, these requirements are substantially different from one regulation to another.

This paper aims to clarify what symbols developed for the MDR compliance may be potentially used by the IVD sector and which ones are not to be used since the IVDR does not make those kinds of requirements.

Posted on 14.01.2020

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