EU Reclassification Directive: adoption by Commissioners before end of July?
This article was originally published in Clinica
As Clinica went to press, there was speculation that the European Directive on the reclassification of joint implants, namely hip shoulders and knees, was due to be finally adopted by the EU's College of Commissioners on July 27. Publication in the Official Journal of the European Union will follow, after which member states will have six months to transpose it into their national law. There will then be a transition period of 18 months by the end of which manufacturers will have to comply with the new rules and submit their design dossiers for notified body review.
You may also be interested in...
Draft policy moots crowdfunding for high-cost rare diseases alongside financial support for those "amenable to one-time treatment" but falls way short of some patient groups' expectations.
India’s Hilleman Laboratories says it’s aiming to develop an affordable vaccine that will target pregnant women in low- and middle-income countries to prevent Group B Streptococcus, a potentially fatal infection passed to babies during childbirth.
Chi-Med’s surufatinib has come up trumps in a second trial in neuroendocrine tumors, after the monitoring committee recommended an early halt following achievement of its PFS target in the pancreatic setting.