Where are we with the EU MDR (2017/745)?
Wednesday, FEBRUARY 26, 2020, 7:00 to 9:00 pm
Topics:
Are you prepared for the major changes required to be in conformity with the European Medical Devices Regulation 2017/745 (MDR) coming into force in 3 months? Compared to the MDD, significant MDR changes include device classification, requirements for technical documentation, and clinical evidence. It compels a life-cycle approach to CE Mark your devices with increased pre- and post-market surveillance requirements, Post-Market Clinical Follow-up (PMCF) studies, and Period Safety Update Reports (PSUR) for Class IIa devices and above. Classifications are expanded, conformity assessment procedures are complex and requirements for clinical data and Clinical Evaluation Reports (CER) will undergo more scrutiny and require recurring updates. All medical devices must meet the standard requirements regardless of class, and except for most class I devices, all must be submitted to the Notified Body for review and CE Certification, no grandfathering. Transitioning to the MDR might seem overwhelming. The first step is to assess your current level of compliance. We’ll discuss many of the important issues this evening to be sure you are on-track.
Discussion:
Participants are encouraged to ask questions about expectations, or to share experiences with their transitions from the MDD to MDR.
Featured Speaker:
Connie Del Buono has spoken to us before at the 2016 NCDG/RAPS Conference on the ISO 13485:2016 and its ramification for the industry. Connie is the Principle for Synoptyx Inc., a regulatory consulting firm based in Sacramento. Connie is a former Notified Body senior project manager for DEKRA Certification BV for whom she continues to serve as a certified Notified Body auditor, on contract, for regulatory Medical Device, IVD, ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) audits . Ms. Del Buono is the former executive vice president of Immuno Concepts, Inc., where she was responsible for manufacturing, product development, and operations and earned a B.A. in biology with a microbiology concentration from the State University College of New York at Plattsburgh.
Moderator:
Barry Craner is a former Chair of NCDG and of the ASQ Biomedical Division (2007-2008), and a long-term member of the planning team for the NCDG.
Location: Stellartech Research Corporation, 560 Cottonwood Dr, Milpitas, CA 95035
Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.
Email: To be added to or removed from our email list, contact George Marcel, gjmarcel@gmail.com.
Registration Link: http://ncdgfeb2020.eventbrite.com/
ONLY Check or Credit Card accepted at door
Questions: For information about this session, contact: George Marcel, at gjmarcel@gmail.com.
Formal discussion and questions will end between 8:30 – 8:40 pm to allow time for networking.
Materials: Presentation & workshop sheets provided for onsite attendees only. Please limit distribution to attendees: personal professional use only.
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Not in the area or cannot be there in person, there is remote access via the web.
Webinar Access (no cost to access): https://attendee.gotowebinar.com/register/3694561783851026444
Event Information
Event Topic:
Where are we with the EU MDR (2017/745)?
Event Description:
Date/Time:
Date(s) - 02/26/20
7:00 pm - 9:00 pm
Event Location:
Other: Stellartech Research Corporation, 560 Cottonwood Dr., Milpitas, CA 95035
Event Details
Event Type