Medical Device Regulations Archives

Software as a Medical Device – Upcoming Changes to the Australian Regulations

By Belinda Dowsett | 29 May 2020

With advancements in software and medical device technology extending beyond the current scope of the Therapeutic Goods Regulations, new legislation is due to take effect in August 2020. Since the...

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...

Article: EU Software Classification under MDR/IVDR – New Guidance Documen

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 –...