NEW MEDICAL DEVICES REGULAMENTATION - PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE
Luca Martinelli Publication 25th November 2016 1.FOREWORD It’s appropriate to underline that as of today (25.11.2016) the Official Journal has not published yet the new regulation. This fact doesn’t prevent to make some considerations about some new features in the final draft. The new Regulation of the European Parliament of the Council on medical devices, amending Directive 2001/83/CE, Regulation (CE) nr. 178/2002 and Regulation (CE) nr. 1223/2009 will replace Directives 90/385/CEE “on the approximation of the States member relating the active implantable medical devices” and 93/42/CEE “on medical devices”, establishes the figure of the “ person responsible for regulatory compliance ”. 2.PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE 2.1 Who is him? The new Regulation requires that the manufacturer must ensure that the supervision and control of medical devices manufacturing, as well as the supervisory and post-market surveillance activities related to them, ...