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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 […]

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Ceci n’est pas une période de transition and first reaction to the Implant Files

02 Dec 2018, Erik Vollebregt

As we are just past the halfway point of the MDR transitional period for the MDR and are well into the one for the IVDR there is one thing that has become very very clear:  the transitional period in the MDR and likely the one in the IVDR is not actually a transitional period for […]

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With Little Movement on Device Regs, EU States Turn to Joint Action Plan

14 Apr 2015, Erik Vollebregt Lack of progress on medical device reform legislation has spurred some EU countries to use last year’s joint immediate action plan to improve device oversight. Regulators using the joint plan will stay…

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In the mean time: a Staff Working Document

23 Jun 2014, Erik Vollebregt It’s been somewhat quiet on this blog for some time, not only because I have been very busy with lots of interesting cases but mainly because there was not a lot going…

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Surprise! Unannounced notified body audits Commission recommendation finally issued

01 Oct 2013, Erik Vollebregt While everybody in the medical devices industry is still reeling from the ENVI vote results (of which we still don’t know what they are in detail because the documents have not been…

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ENVI's 29 may debate on medical devices

29 May 2013, Erik Vollebregt The fog of war that I wrote about with respect to the tsunami of amendments is lifting with the discussion of the amendments in the ENVI committee today. It was a very…

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Unannounced notified body visits recommendation imminent – amend your contracts and procedures now!

27 Mar 2013, Erik Vollebregt While everybody is running around about the MDR and IVD regulations proposals another storm is brewing in the wings: unannounced audits, which I announced earlier. Currently notified bodies “may” do unannounced audits…

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Fireworks! Or a disappointing dud? The 26 February ENVI workshop on the EU medical devices and IVD proposals

21 Feb 2013, Erik Vollebregt With the ENVI committee “workshop” on the medical devices regulation and IVD regulation proposals in sight next week, medical devices media have been drumming up momentum by using exciting adjectives like “fireworks” that make…

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"U" is for unannounced audits – what's up with those?

05 Nov 2012, Erik Vollebregt I visited the RAPS Regulatory Convergence conference in Seattle, which provides for a very nice opportunity to catch up with the European medical devices crowd that had gathered in numbers to explain…