Atlanta Chapter Event: Challenges and Lessons Learned From Both an Industry and Notified Body Perspective for the Implementation of EU Regulations.

2.5
RAC Credits
Chapter EventsChapter Events
Wednesday, 12 October 2022 (4:00 PM) - Wednesday, 12 October 2022 (6:30 PM) Eastern Time (US & Canada)
115 Perimeter Center Pl NE
Atlanta, Georgia, USA, 30346-1249

From the Notified Body perspective there have been significant challenges with the implementation of the new Medical Device Regulations from the EU, which in turn has caused potentially difficult decisions for medical device manufacturers and the overall impact of those decisions on the EU healthcare system. The EU Medical Device Directives (MDD) expired on May 25, 2021, replaced by the new Medical Device Regulations (MDR). The transition period will remain in effect until May 25, 2024, but holders of MDD certificates will need to move to MDR certification as soon as possible, considering the certificate expiration date, the complexity of the new regulation, and the limited resources of European Notified Bodies. Our first presentation will discuss the challenges facing the Notified Body system, the potential difficult decisions that medical device manufacturers will have to make when they determine their regulatory strategy, the practical reality of changing notified bodies and/or working with multiple notified bodies (e.g., in case of M&A of a startup), and the overall impact to the EU healthcare system.

Companies need to be finalizing their plans for MDR and IVDR implementation. This program will examine MDR from the notified body perspective.

Learning Objectives

Gain a better understanding of key roadblocks and possible mitigations with implementation of the new EU regulations for medical devices.


Audience Learning Level

Intermediate to advanced level.


Who Should Attend

Regulatory Affairs, R&D, Engineering, and Quality personnel.


Registration Fees

Members: $25
Student Members: $15
NonMembers: $35

Registration fee includes:

  • Light food and beverages will be provided

Speakers:

Balázs Bozsik

Balázs Bozsik
Technical Director - MDD/MDR, SGS

With a passion for continuous improvement, Mr. Balazs Bozsik is the Technical Director for the medical audit team of SGS North America. Following his graduation as an integrated mechanical engineer from BUTE in Budapest, Hungary, he gained industrial experience in manufacturing technology and design engineering in the medical (X-ray diagnostic devices), automotive, and consumer lighting industries.

Prior to joining SGS, he worked for another TIC organization for over 14 years, including his roles as global MDSAP Program Manager, certification officer, product specialist focusing on active medical devices and medical software, as well as a medical auditor for all major certification schemes.


Location


115 Perimeter Center Place, Atlanta, GA 30346, United States


Vaccination Requirement

RAPS will require proof of COVID-19 vaccination or proof of a negative PCR test taken within 24 hours of arrival in order to attend. Unvaccinated individuals or those unable to provide proof of vaccination or a negative PCR test will not be permitted to attend.

RAPS will continue to monitor any new developments and evaluate what is needed to ensure you are comfortable and we meet safely. We will keep all participants updated as we get closer to the event.


Be Well Policy

Participants must follow RAPS’ Be Well policy, which requires consent during registration by all attendees as a condition of on-site participation. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while on site in St. Paul, you will reconsider your participation at the event. To help ensure your personal safety and comfort, RAPS is committed to robust and transparent communications. We encourage all participants to monitor RAPS’ social media channels to receive the latest updates.


Cancellations and Refunds

All cancellation requests must be submitted in writing to support@raps.org. Cancellation requests received by Wednesday; 5 October 2022 will receive a full refund. Cancellation requests received after 5 October 2022 will be non-refundable, except in cases of documented medical emergencies. RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.


Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.


Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org 

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