EU Medical Devices Directive Review Invites Reclassification Requests
This article was originally published in The Gray Sheet
Executive Summary
The European Commission is encouraging member states to use Article 13 of the Medical Devices Directive to submit requests for reclassification, rather than reforming the directive itself
You may also be interested in...
MDD Needs Notified Body, Transparency Overhaul – European Commission
Medium-risk device categorization will be addressed by the European Commission in an upcoming proposal to modify Annex II of the Medical Devices Directive
MDD Needs Notified Body, Transparency Overhaul – European Commission
Medium-risk device categorization will be addressed by the European Commission in an upcoming proposal to modify Annex II of the Medical Devices Directive
EU Firms Back MDD, Public Health Shift; Class IIb, Transparency Issues Linger
European industry leaders support shifting medical device oversight within the European Commission from the directorate general for industry (DG Enterprise) to DG Sanco, the committee responsible for health and consumer protection