Month: April 2020

The Medical Device Coordination Group just released a guidance document on Notified Body audits during the ongoing COVID-19 pandemic. It takes immediate effect and is valid for the period of the duration of the pandemic as declared by the WHO. It covers alternative solutions to carrying out on-site audits by notified bodies under the medical …

New MDCG “guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions” Read More »

The amended MDR (2017/745, amended by 2020/561) has been made available on the EU website here. If you haven’t been keeping up, the main change is that it moves the Date of Application of the MDR back one year, from May 26th 2020 to May 26th 2021. I have covered it more in depth in …

Amended MDR available Read More »

Last week the European Parliament overwhelmingly voted in favor of the Commission proposal to amend the MDR. Even though this was just a vote in the first reading, it is now almost a certainty that the Date of Application of the MDR will be moved to May 26th 2021, as the Council has already confirmed …

MDR Date of Application move now almost a certainty Read More »