Medical device CE marking

MedTech published recommendations on the use of guidance documents


This Position Paper concerns documents that assist stakeholders to implement the Medical Devices Regulation, 2017/745 (“MDR”) and the In Vitro Medical Devices Regulation, 2017/746 (“IVDR”). In order to assure market availability of safe and performing medical devices, this Position Paper lays out an industry view on expectations for the use and pragmatic timing of application of such documents.

The document can be downloaded in our library

Source: MedTech Europe