Medical Device Regulations

Deadline extended

Some Class I Device Transitions Extended – MDR

Under growing pressure from industry and notified bodies, the need to provide some breathing space around MDR deadlines by the European Commission has finally been considered. After much focus on...
Software

EU Software Classification under MDR/IVDR – New Guidance Document

In October 2019 the Medical Device Coordination Group (MDCG) released a new guidance document on Qualification and Classification of Software in the European Regulations 2017/745 – MDR and 2017/746 –...

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