Article

MDR date of application move: politically a done deal now

19 Apr 2020, With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After…

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

08 Apr 2020, When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes…

Article

MDR amendment proposal article 120 (3) oversight set to be fixed by Council

08 Apr 2020, It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR…

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The MDR amendment proposal: more than meets the eye

04 Apr 2020, On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in…

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Commission working on proposal to postpone MDR date of application for one year

25 Mar 2020, After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about…

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The MDCG guidance on significant changes – a significant change?

21 Mar 2020, It’s hard to keep up with all the work and the new publications of guidance these days. Abundance creates its own problems one could say, so that’s why this blog was slightly…

Article

The MDCG guidance on significant changes – a significant change?

21 Mar 2020, Erik Vollebregt

It’s hard to keep up with all the work and the new publications of guidance these days. Abundance creates its own problems one could say, so that’s why this blog was slightly delayed. Due to the COVID-19 epidemic I have had to home quarantine the family, move the whole law firm to a virtual platform […]

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The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck

20 Mar 2020, What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would…

Article

The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck

20 Mar 2020, Erik Vollebregt

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]