Events

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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…
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An unsurprising case of software qualification

First: my apologies for the collapsed frequency of articles on this blog – I’m very very busy, literally day and night, with questions about any and all aspects of the MDR and…
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Can unhealthy foods enter the ‘health halo’? The boundaries of health claims in the absence of nutrient profiles

To date, about 30% of pre-packed food products marketed in the EU have entered the ‘health halo’, attracting consumers by scientifically proven health benefits. The Claims Regulation provides that food products must…
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Netherlands to adopt medical devices anti-corruption legislation

As we say in Dutch: the day that you knew that would come is finally here. The legislative proposal to grant the Healthcare Inspectorate (IGZ) IGZ enforcement powers in the field of…
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Presentations MDR Implementation Seminar

With the definite text published less than a week ago, we welcomed over 150 industry representatives interested in the new Medical Devices Regulation. Erik Vollebregt kicked off the seminar with his presentation…
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Final MDR and IVDR texts published

As Agent Smith said: “You hear that Mr. Anderson?… That is the sound of inevitability…”. Today’s EU Official Journal contains the final final final texts of the MDR (finally numbered as Regulation (EU)…
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MDR and IVDR to be published this Friday

Mark 5 May 2017 in your calendar – this date will be a landmark for EU medical devices law because the MDR and IVDR will be published in the EU Official Journal….
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We are looking forward to meet you!

My apologies for the incidental self-promotion. Our practice continues to grow and that means we are always looking for people to staff our firm. We currently have vacancies for a number of lawyers at different…
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Axon Seminar on Medical Devices Regulation Implementation

Please click on title for programme and invitation