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Erik Vollebregt of Axon Lawyers, Amsterdam

Ronald has unique ways of approaching a problem. He always looks at it from multiple perspectives and is great at seeing what could be lurking around the corner, or which may have been put in a closet out of sight. Personally I like to discuss complex borderline and classification issues with him and he is … Read more

When is UKCA marking necessary?

UKCA marking for different product categories Now the UK has left the EU, the timelines for accepting CE marking on the Great Britain market are coming to an end. All CE marked products must be UKCA marked by 1 January 2023, except for medical devices and IVD’s which must be UKCA marked by 1 July … Read more

Emergency assistance

Any company can suddenly be hit by a complex and high risk case. In such situations it is necessary to get a good understanding of the underlying problem and of the expectations by the authorities and notified body, and also to ensure proper communication with all stakeholders, including the press. Leaning on in person experience … Read more

Justification of product status and risk class

The justification of the status of a medical device or IVD and their risk class is where you make the first impression Annex VII, Requirements to be met by notified bodies, describes among other things, how a notified body will review applications for certification (Annex VII, section 4.3). These are the first hurdle a company … Read more