Notified Bodies

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

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

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

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

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

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!

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

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?

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…

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Axon Seminar In Vitro Diagnostics Wednesday 12 September 2012

Bringing an in vitro diagnostic product to the market is challenging and complex. Rules at the EU and national level are constantly changing, while regulatory policy is developing to get to grips…

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