Axon Seminar Clinical Trials with Medicinal Products and Medical Devices on 9 April in Amsterdam
I recently reported about the proposal to amend the IVDR immediately when it came out – please excuse the initial inaccuracies in the post on the subject of amendments to article 5…
It had been been in the works for some time, although it also seemed unlikely for quite some time that this would happen. The implementation of the IVDR had been the slow…
On May 5 2021 the General Court published a (lengthy) judgement in which it annulled the decision of EMA to not validate (and thus not accept and review) a marketing authorization application…