Robert Christensen Well, that will be welcome. You all know what I went through. If not, read my book, FDA You Were WRONG!

Julie Omohundro Hard to say from a set of slides, but it seems like transparency will remain the EU's Achilles heel.

It looks like the definition of "public" will be that the Member states and Commission will have unlimited access while healthcare providers and patients will have access to information only on a "need to know" basis, heh. So still pretty much insiders only.

It also appears that nothing equivalent to EIRs or decision summaries will be made available to much of anyone other than the applicable CA, the notified body, and the individual company.