Document paper New medtech regulations

Recommendations on the use of Guidance Documents Related to the Medical Device Regulation (MDR) and In vitro Diagnostics Regulation (IVDR)

The Medical Devices Coordination Group (MDCG) uses guidance documents to assist stakeholders in implementing the medical devices regulations, by informing, enhancing, elaborating, or interpreting the content of the legal texts. With this paper MedTech Europe provides its view on how guidance documents should be used in a way that do not disrupt manufacturers’ efforts to transition to the new rules of the MDR and IVDR.

 

Posted on 30.06.2022

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