placing on the market


The Blue Guide 2022 update – new elements regarding applicability of EU law on products

As announced in my previous blog post providing a general overview of my impression of the changes made in the Blue Guide 2022 compared to the previous 2016 version, this blog post follows up in detail on the changes in Chapter 2. Chapter 2 of the Blue Guide explains when EU law on products applies, […]


MDCG 2021-27 Q&A on importers and distributors – sort of box of chocolates

Life, as they say, is like a box of chocolates: you never know what you’re going to get. MDCG guidance documents are very much like that too. Even if you’ve seen them coming in the consultation phase the end result may still surprise you. Some are really good, some are really good and complex, some […]


EU Court judgment may add 6.5% customs tariff burden for parts/accessories of medical devices

And now for something completely different: customs tariffs. Dry stuff, but it makes all the difference for the price of the device. Indeed, ‘parts’ and/or ‘accessories’ under heading 9018 of the Combined…


Improving implementation: the Code for Notified Bodies

It’s finally public: the Code of Conduct for Notified Bodies under Directives 90/385/EEC and 93/42/EEC “Improving implementation of the European CE certification of medical devices through harmonization of quality and competence of…


Advertising and marketing of medical devices in the EU: seminar/webinar 8 June in Amsterdam

Advertising and marketing of medical devices is a subject I see many clients struggle with. Unlike with medicinal products EU law in the field of advertising and marketing is almost not harmonised….


To place on the market (or not)

That is the question. It is in fact on of the core questions of the three medical devices directives (the Medical Devices Directive, the In Vitro Diagnostics Directive and the Active Implantable…

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