Category - white paper


Can we fix / improve the MDR and the IVDR?

Or in other words that I’ve asked on this blog before: can the maker repair what he makes? This blog will argue that he can and he should. It still happens to me: people that say that the MDR or IVDR is ‘new’. In a way of course they are if you look at things […]


New white paper on MDR (and where is the MDR anyway?)

When Gert Bos and I wrote BSI’s white paper on the impending EU medical devices regulation and the IVD regulation, the white paper was received very well but we also received requests to write something more detailed and practical. Here it is So we did just that. And here it is – the next BSI […]


BSI white paper on EU medical devices revision

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 […]