How novel is your food?

If you like to add a new ingredient to – for example – a beverage or want to start selling ‘superberries’ or an exotic seed from Asia in the EU, you should…


Standalone software regulated as medical device: a look under the hood of the draft MEDDEV

Sometimes you have to go far away to learn a lot about thing close to home and that is what happened to me at the RAPS Regulatory Convergence Conference that I am…


New EU Commission guidance on medical devices borderline products and classification

Yesterday the European Commission’s Working Group on Borderline and Classification issued the new version (1.10) of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. This manual…

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