INTERVIEW: Schroeer on EU regulatory plans for single-use devices
This article was originally published in Clinica
Executive Summary
“A significant shift” is how Peter Schroeer, director of regulatory affairs for EMEA at Johnson & Johnson’s Global Surgery group, described the change made by European Parliament committee ENVI to the European Commission’s original proposal for EU regulations of single-use devices and reprocessing. Clinica’s medtech regulatory affairs editor Amanda Maxwell caught up with Mr Schroeer at the European Medtech Forum, held 9-11 October in Brussels, to find out more about his views on ENVI’s amendments to the proposed rule related specifically to the reprocessing of devices (voted through on 25 September, see www.clinica.co.uk), what it means for industry and what possibility there is for further changes to the rule before Parliaments plenary vote scheduled on 22 October.