From the Notified Body perspective there have been significant challenges with the implementation of the new Medical Device Regulations, which in turn has caused potentially difficult decisions for medical device manufacturers and the overall impact of those decisions on the EU healthcare system.
Some of those challenges are, but not limited to are:
- CEP does not meet MDR requirement
- Insufficient clinical evidence for legacy devices; does not meet MDCG 2020-06
- Equivalence does not meet MDCG 2020-05
- WET in MDR is only limited to the list in Article 61(6b), while many manufacturers misinterpret the definition of MDCG2020-06
- PMS plan does not meet the MDR requirements
- Still justifying no PMCF plan/report, which is not acceptable under MDR
- Lack of compliance with the requirements of PSUR and SSCP
The EU Medical Device Directives (MDD) expired on May 25, 2021, replaced by the new Medical Device Regulations (MDR). The transition period has been extended for those manufacturers seeking MDR, but holders of MDD certificates will need to move to MDR certification as soon as possible, considering the limited resources of European Notified Bodies. Our presentation will discuss these challenges, and the potential difficult decisions that medical device manufacturers will have to make, and the overall impact to the EU healthcare system.
This event is brought to you by the RAPS Florida Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.5 RAC recertification credit.
REGISTRATION FEES
Free
Learning Objectives
Participants will gain a better understanding of the CER and PMS for orthopedic and other devices and possible mitigations with implementation of the new EU regulations for medical devices.
Audience Learning Level
Learning Level: Intermediate – attendees should already be familiar with the EU regulations.
Content is: Beginner/Intermediate
Who Should Attend?
Regulatory Affairs, R&D, Engineering, and Quality personnel
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.
Cancellations
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. 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 raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of
Attendance
A certificate of attendance can be downloaded
from the RAPS Learning Portal
following the event.
Questions
For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-help
For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.