Unpacking the EU MDR 2017/745 to understand the impact
Speaker: Chris Longpre, Senior Quality Manager, Abbott
The current Active Implantable/Medical Device Directives (AIMDD and MDD) are being replaced by a new Medical Device Regulation (EU MDR). Described as the most disruptive regulatory change in Europe in over 20 years, compliance to the new MDR is required to gain and/or retain CE mark for medical devices. Since the issuance of MDD and AIMDD certificates will cease in May 2020, medical device manufacturers must act during this transition period to update their technical documentation and processes in order to meet the new MDR requirements. Please join us as we discuss the new regulation and the impacts it will have on industry.
Chris Longpre, Senior Quality Manager, is the Abbott Neuromodulation business unit leader for EU Medical Device Regulation (MDR) implementation and brings 15 years of quality and operations experience, most of which is in the medical device space. His background lies in a variety of leadership positions across quality engineering, quality systems, operations, integration, and remediation efforts with active implantable, cardiovascular, and general surgery products. Chris is a graduate of the University of Michigan in Ann Arbor with a degree in Chemical Engineering.