Articles



Article

Bottlenecks, Brexit and stalling CAMD roll-out

With the summer holidays about to happen and the halfway point of the three year transitional period for the MDR on the horizon, let’s take stock of where we are. If you…
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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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Axon Seminar on Medical Devices Regulation Implementation

Please click on title for programme and invitation

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Software MEDDEV ‘updated’

The Commission issued an updated version of the MEDDEV 2.1/6 regarding standalone software on 15 July. After all the rumors around the difficult discussions surrounding the revision process I was very curious…
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Presentations Axon Seminar on the General Data Protection Regulation

Another well-attended seminar we hosted this week. Please find below links to the presentations: Erik Vollebregt, Axon Lawyers – GDPR Impact on Healthcare; Loes Markenstein, Dutch Data Protection Agency – DDPA’s assessment…
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Axon seminar on General Data Protection Regulation

The EU General Data Protection Regulation (GDPR) text has been finalized and the regulation will enter into force soon, setting the legal framework for processing of personal data in the EU for…
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Wearables Seminar Presentations

A lot of people turned up at this seminar on wearables and the regulatory, legal and commerical aspects. In case you were not able to make it, please find the presentations below:…
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Axon Seminar on Wearables 20 April

The seminar addresses current and future legal and regulatory developments relevant to the health related wearables industry, especially medical devices regulation and protection of personal data. It will address market access requirements and give practical how-to guidance on how to design and CE mark a compliant wearable and related software.

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Employee use of wearables in breach of Dutch privacy law

The Dutch Data Protection Authority (‘DPA’) has found that the processing of employee wearable data by employers is in breach of the Dutch Data Protection Act, read more

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