Are you still with me on where we are with the EU revision of medical devices and IVD legislation?

If you are, you have strong tolerances for fast moving complexity – congratulations! – because so far it has been a wild ride so far with drama, denial and divergence. And it looks like it will not be finished soon.

If you’re not, don’t blame yourself. It is not surprising that you may feel a bit in the dark about where exactly the whole process is, and what the bigger picture looks like. Well, fret no more.

BSI Healthcare decided that it would be a good idea to produce a nice concise white paper explaining the bigger picture, subtitled “An overview of the likely outcomes and the consequences for the market” so no dry descriptions of procedural steps or repeating of what everybody else is saying.

I was honored that BSI asked me to contribute and it was a pleasure to work on it with Gert Bos (Head of Regulatory and Clinical Affairs at BSI). We are very grateful for the work put in by the expert reviewers and members of BSI’s medical devices white paper advisory panel.

And here it is. I hope you will find it useful.

We have not only tried to be as practical as possible (and managed with the help of our reviewers), but have also discussed subjects like future-proofing of the new regulations, 3D printing of devices, impact on own brand labelling and how to manage your transitional processes (mind you: the EU does not allow grandfathering of devices so all your existing devices must be certified under the new rules sooner or later).

Are you in IVDs? Then you are up for a regulatory quantum leap, which is discussed in a fair amount of detail as well. The discussion is focused way too much on the medical devices regulation proposal, while the IVD market is awaiting some big regulatory changes as well.

It’s also one of a series of white papers in medical devices that BSI will produce in the course of this year, so there is more to come.