Indiana Chapter Webcast: Challenges and Lessons Learned from Both an Industry and Notified Body Perspective for the Implementation of EU Regulations

RAC Credits
Chapter Events Chapter Events
Tuesday, 26 July 2022 (3:30 PM) - Tuesday, 26 July 2022 (5:00 PM) Eastern Time (US & Canada)

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 25 May 2021, replaced by the new Medical Device Regulations (MDR). The transition period will remain in effect until 25 May 2024. Still, holders of MDD certificates will need to move to MDR certification as soon as possible, considering the certificate's 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 make when determining regulatory strategy; the practical reality of either changing notified bodies or working with multiple notified bodies (e.g., in the case of M&A of a startup); and the overall impact to the EU healthcare system.

Our second presentation comes from an Industry perspective.  With the lack of guidance surrounding IVDR, it is critical to learn from others within the industry to avoid reinventing the wheel.  The second speaker’s organization has been audited to IVDR and recommended for certification with their product submissions in the final stages of approval. As one of the few companies to go through the process, they have offered to share their experience.

This event is brought to you by the RAPS Indiana Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.5 RAC recertification credit.


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

A live Q&A portion with the speaker will follow the presentation.


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


Enterprise Member: Free
RAPS Member: Free
>Nonmember: $25


Learning Level:   Intermediate – attendees should already be familiar with the EU regulations.
Content is   Beginner/Intermediate


For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation.


RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits of RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.


Balázs Bozsik
Technical Director - MDD/MDR, SGS North America

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.

Heidi Strunk, RAC
Senior Director, Quality and Regulatory Affairs, Hologic

Heidi Strunk is a regulatory and quality professional with extensive experience in the medical device, in vitro diagnostic (IVD) and life sciences industries on a global scale. She brings to the table over thirty years’ experience in FDA-regulated industries, including nineteen years in management. Her breadth of experience spans large companies to hyper-growth start-ups, mergers/acquisitions, and transfer of product lines into and out of the USA.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

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 with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the webcast.


Contact the RAPS Support Center:

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

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