Industry scouting for best outcome for EU medical technology companies facing dual compliance task
This article was originally published in Clinica
Executive Summary
Device companies operating in the EU that are likely to be affected by the overlap in essential requirements under the revised medical devices and active implantables directives (93/42 and 90/385) and the machinery Directive 2006/42 (see Clinica No 1263, p 1) will probably not be able to rely on last-minute help from the EU Council.