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Transparency vs. Confidentiality: EFSA’s new role as from March 2021

Last month, the European Council formally adopted the new Regulation on the transparency of the EU risk assessment in the food chain, which will be applicable as of 26 March 2021. As is in the name, the new provisions aim at increased transparency of EU risk assessment, which for a large deal means strengthening the […]

€ 500 per data subject – a quantification of why GDPR matters

Clients often ask me why they should invest in General Data Protection Regulation (GDPR) compliance so much. For medical devices and medicines regulatory compliance, they get it to an extent. Non-compliant devices carry risk of enforcement, which can lead to them being taken off the market. Devices off the market = collapse of cash flow […]


Vanilla custard or custard with vanilla taste?

In a recent decision of the Board of Appeal of the Dutch Advertising Code Committee (ACC), it was made clear that providing food information to consumers is serious business. The ACC in the Netherlands is a self-regulatory body, comparable to the Advertising Standards Authority in the UK and the German Advertising Standards Council (“Deutscher Werberat”)  […]


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New sort of applicable economic operators regulation: the Market Surveillance Regulation

Attentive attendees of my presentations will have remarked in my presentations about economic operators that essential parts of the general Goods Package were being amended and that this may affect companies in…
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Article

Transparency vs. Confidentiality: EFSA’s new role as from March 2021

Last month, the European Council formally adopted the new Regulation on the transparency of the EU risk assessment in the food chain, which will be applicable as of 26 March 2021. As is in the name, the new provisions aim at increased transparency of EU risk assessment, which for a large deal means strengthening the […]

Article

€ 500 per data subject – a quantification of why GDPR matters

Clients often ask me why they should invest in General Data Protection Regulation (GDPR) compliance so much. For medical devices and medicines regulatory compliance, they get it to an extent. Non-compliant devices…
Read more

Article

€ 500 per data subject – a quantification of why GDPR matters

Clients often ask me why they should invest in General Data Protection Regulation (GDPR) compliance so much. For medical devices and medicines regulatory compliance, they get it to an extent. Non-compliant devices carry risk of enforcement, which can lead to them being taken off the market. Devices off the market = collapse of cash flow […]

Article

Qserve / Axon EU MDR and IVDR pop-up conference in Boston MA on 18 July

Qserve Group and Axon Lawyers (my law firm) are organizing a pop-up mini conference about the new EU Medical Devices (MDR) and IVD Regulations (IVDR) at Qserve’s Boston MA office in the…
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PRRC guidance under MDR and IVDR published

The MDCG has just published its guidance on the PRRC, MDCG 2019-7 “Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person…
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Bottleneck of bottlenecks for notified body capacity

People that are downplaying the notified body bottleneck may need to start to revisit their position with notified body LRQA now also dropping out of the notified body pool for medical devices…
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Article

Vanilla custard or custard with vanilla taste?

In a recent decision of the Board of Appeal of the Dutch Advertising Code Committee (ACC), it was made clear that providing food information to consumers is serious business. The ACC in the Netherlands is a self-regulatory body, comparable to the Advertising Standards Authority in the UK and the German Advertising Standards Council (“Deutscher Werberat”)  […]

Article

Trends at Vitafoods … and what you should know if you decide to be part of it

From 7 – 9 May 2019, the Vitafoods conference took place again in Geneva. For a few years in a row, I presented at the Education Program. This year I was asked to discuss the application of CBD in food products, which is currently a hot topic. Below, I will share the insight from my […]

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