Extractables and Leachables USA

NAMSA invites you to join us at the Extractables and Leachables USA on April 5-7. Throughout this two-day conference, industry experts will examine the safety, quality and regulatory issues central to the medtech industry. Networking opportunities are also available throughout the event for attendees to share best practices and real-world experiences.

NAMSA EDUCATION SESSION
EU MDR Update
Presented by Valériane Levelut, PharmD, ERT, DABT; Toxicologist, NAMSA
April 6, 2022 | 10:00-10:30 AM ET

Description: On May 26, 2021, the EU Medical Devices Regulation (MDR, Reg. No. 2017/745) became fully applicable and enforceable by law, and compliance with the General Safety and Performance Requirements (GSPR) is the keystone for establishing conformity with the EU MDR. The GSPR, which replaces the EU Medical Device Directive (MDD), introduces new biocompatibility evaluation requirements for medical devices. For example, GSPR 10.4.1 focuses on carcinogenic, mutagenic or reprotoxic (CMR) and endocrine disrupting (ED) compounds when present at a concentration above 0.1% w/w in high-risk medical devices. This presentation will provide insight of current European Regulation chemical compounds (REACH, CLP) and its link with MDR, and will propose an approach on how to address the presence of CMR and ED compounds in medical devices. In addition, recent feedbacks from Notified Bodies will be presented. Examples will include deficiencies related to the toxicological risk assessment of CMR and ED compounds, degradation products and extractables/leachables.

COMPLIMENTARY CONSULTATIONS
NAMSA’s medical device experts will be available on-site for consultations. We welcome the opportunity to discuss the various pathways to market and suggestions on how to most efficiently and cost-effectively achieve market success based on your unique project objectives. Please contact us to reserve your consultation time.