New EU medtech proposals: The political line up and potential stumbling blocks
This article was originally published in Clinica
Executive Summary
There is a sense of urgency that the European Commission’s proposals for a Regulation on medical devices and one on IVDs should be agreed by the European Parliament and Council and adopted by mid-2014. If not, they could face very serious delays because of the potential disruption caused by the European Parliament elections taking place that year. But what actually is a realistic timeframe for the adopting the proposals and who will influence it? Amanda Maxwell reports from the Association of British Healthcare Industries (ABHI) meeting held on 17 October in London
You may also be interested in...
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.