EU MDR - ARE YOU PREPARED? IT'S NOT TOO LATE. THE SESSION WILL REVIEW THE GENERAL SAFETY & PERFORMANCE REQUIREMENTS OF THE EU MDR FOR THE BIOCOMPATIBILITY OF MEDICAL DEVICES - Hosted by NAMSA
Tue. February 5| 9:50 AM - 10:30 AM | 209B
Audience Level: All
Show: General
Track: Classroom Seminar
Focus: 3D Printing, Contract Manufacturing, Design & Product Development, F&B Packaging, Injection Molding, Labels & Labelling, Materials, Robotics & Automation
What is EU-MDR and is your device technical documentation updated to meet the European Union's (EU) Medical Device Regulation (MDR) 2017/745 General Safety and Performance Requirements? If not, this session will provide best practices and meaningful tips for manufacturers with devices sold under CE marks and will explain how the EU MDR requirements supersede current EU MDD 93/42 and 2007/47 requirements as they relate to Biocompatibility throughout the full medical device lifecycle.
Also discussed will be information on the specific areas of the EU MDR that enhance ISO 10993-1:2018, as well as other guidelines that support EU MDR requirements for deeper assessment, reduction and control of Biological Risk as they relate to patient concerns.
Lastly, critical MDR information will be provided based on NAMSA's many interactions with EU Notified Bodies and agencies pertaining to the newly expanded requirements.
Also discussed will be information on the specific areas of the EU MDR that enhance ISO 10993-1:2018, as well as other guidelines that support EU MDR requirements for deeper assessment, reduction and control of Biological Risk as they relate to patient concerns.
Lastly, critical MDR information will be provided based on NAMSA's many interactions with EU Notified Bodies and agencies pertaining to the newly expanded requirements.
RSVP Here:
https://mdmwest.mddionline.com/namsa
