Wisconsin In-person Chapter Event: Challenges and Lessons Learned from both an Industry and Notified Body Perspective for the Implementation of EU Regulations

RAC Credits
In-PersonIn-Person Chapter EventsChapter Events
Thursday, 30 March 2023 (6:00 PM) - Thursday, 30 March 2023 (8:30 PM) Central Time (US & Canada)
1637 W Wisconsin Ave
Milwaukee, Wisconsin, USA, 53233-2111

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'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 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.


Price: Free

After this program, participants will:

Participants in this presentation will gain a better understanding of key roadblocks and possible mitigations with implementation of the new EU regulations for medical devices.

Who Should Attend?

Regulatory Affairs, Research & Development and Quality professionals.

Parking accommodations

Paid parking is available in the 16th Street Parking Lot (Structure 1) at 749 N. 16th Street. Metered street parking may also be available.


Balazs Bozsik

Balazs Bozsik

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.


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 raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant, and contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.



For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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