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.
medicaldeviceslegal 
Nice job, very helpful. Thanks!
Thanks for this.
On my daily work there is also an activity that require to be followed and that is not really clear on the Medical Device’s Regulation (as it is for Drug products) but appears on the general CE mark regulation, it’s about promotion of a product.
I suggest to add two more Directives if you think this is relevant:
– Directive 2006/114/EC concerning misleading and comparative advertising
– Directive 2005/29/EC concerning unfair business-to-consumer commercial practices in the internal market
I suggest adding regs and directives that apply too chemicals such as chemical stereilants, enzymatic solutions, etc. used for endoscopes and similar devices
Hi Sofie, great list!
This Regulation is missing: No 348/2013 of 17 April 2013 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
Thanks Adriaan, we’ll add that one.
Erik, This is a great resource and as we have discussed I am working on posting this on my website http://www.EisnerSafety.com so more of the medical device industry is aware of this really helpful resource. Thx for sharing and making this available to so many people. It is greatly appreciated. Will you repost every time you make updates to the document or how will you let those that have downloaded it know that the document is updated?
Cheers,
Thanks Leo, we’re collecting feedback to the list and will of course repost new versions on this blog. Also, the RAPS Dutch chapter will provide new versions to its members when these become available.