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Medical Device Regulations

Deadline extended

Some Class I Device Transitions Extended – MDR

By Grant Bennett | 3 February, 2020
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

By Yervant Chijian | 28 October, 2019
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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Some Class I Device Transitions Extended – MDR

Feb 3, 2020

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Dec 20, 2019

Brexit appears inevitable – and it seems UK MHRA will emulate New Zealand!

Dec 19, 2019

A single review program for medical devices?

Dec 2, 2019

The door to Europe is closed – so where else should I look?

Dec 2, 2019

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