MDR

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National MDR and IVDR implementation news – Netherlands implementation decree consultation

While nothing much comes out at EU level and member states seem to wait until the last moment with implementing legislation (because the people needed for that are caught up in the gridlocked Brussels MDR and IVDR implementation process as a result of structural under-resourcing of medical devices oversight) some member states are really on […]

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What to expect for 2019 with MDR and IVDR implementation?

Remember the CAMD Roadmap (dating back to end 2017) that promised us a roll-out of MDR and IVDR items that were sometimes even marked ‘high priority’ and how that lifted our spirits (at the time)? Remember how this was supplemented with the Rolling Plan, which promised the roll-out of all roll-outs for 2019? I have […]

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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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MDR and IVDR transitioning – where are you in your process?

I see in practice that some companies are well on their way with implementing the new MDR and IVDR regulations, while a lot of others are not. It will be interesting where everyone will be by the time the transitional period of the MDR ends and then when the IVDR transitional period ends. This post […]

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MDR and IVDR adopted by Parliament – entry into force imminent

Completely in line with expectations the Parliament adopted the texts of the MDR and the IVDR yesterday. I have nothing to add to that in addition to previous posts in this blog. It is what it already was. The texts can be found here. This means that we are now looking at publication in the Official […]

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Update on MDR/IVDR trilogue

The trilogue has been quietly progressing, with a view to being concluded for this Presidency at the EPSCO meeting of the Council on 8 December after a final trilogue meeting planned on 3 December….

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Update! White paper on MDR / IVDR updated

In March 2014 Gert Bos (Head of Regulatory and Clinical Affairs at notified body BSI) and I wrote a white paper on the new EU medical devices and IVD regulations in the legislative procedure….

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