A EU medical devices regulation chart

Een bijdrage van Erik Vollebregt en Sofie van der Meulen, Axon Lawyers.

And now for something completely different from all the discussion about future rules and where they may take us: the RAPS Dutch/Flanders chapter has been active in defining a list of EU legislation that does not directly regulate medical devices but catches them in its scope, like environmental design requirements for electronic devices.

This resulted in an initial helpful overview in Dutch, which my firm offered to expand to an English language document that includes not only active links to the underlying legislative texts, but also to the EU law summaries in the ScadPlus database (if available) and to the EU Commission web pages with explanation about the rules concerned.

So that’s what we did – and you can download it here, for free, no strings attached, no need to give us your email address, mobile number and birthday and all that (we hate it if we get asked to provide that too so we won’t bug you for that).

We would really appreciate though if you would tell us if you don’t agree with this chart, or if you have helpful additions because you think it’s incomplete. Also, mind you – this list is in constant flux because these rules tend to be amended a lot. If you’re not sure at any point, we – and in particular our new devices lawyer Sofie van der Meulen (who prepared the overview and presented it on 26 April at the RAPS chapter meeting) – can help you figure it out. Also, if you’re active in medical devices in the Netherlands and Belgium, becoming member of the RAPS Dutch speaking chapter is a good idea because they do many useful things, and this initiative is only one of them. They don’t have a website yet, but you can keep track of them by joining their LinkedIn group.