Industry Gives EU’s “Pip Resolution” Lukewarm Welcome
April 27, 2012 – 9:04 amThe Pip resolution, drafted by the Environment and Public Health (ENVI) Committee of the European Parliament and unanimously passed on 25 April, is a mixed bag, according to Eucomed. The pan-European association applauds many of the measures, including greater oversight of Notified Bodies, more robust vigilance reporting, the introduction of unannounced audits of manufacturers and the establishment of networked registers for implants.
Eucomed, however, was puzzled, to say the least, by the resolution’s call for a preauthorisation system for implantable and Class III devices. “Europe currently has a de facto approval system for these devices,” the association notes in a press release. Read more…





