Western Canada Chapter Virtual Event: IVDR - Best Approaches on Handling Transitional Requirements a

Since its publication in July 2022, manufacturers of certain Class D IVDs have been challenged by best approaches to demonstrate compliance with key requirements of EU Regulation 2022/1107 as part of the IVDR certification process. One of the primary objectives of this regulation was to address public health concerns posed by significant risks associated with the use of certain Class D IVDs such as those intended for detecting and/or quantifying blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems, markers of HIV, HTLV, HBV, HCV, and HDV infections. On top of this, in January 2024, the European Commission proposed new transitional provisions for certain IVDs, partly due to significant resource and capacity limitations following substantial changes introduced by the IVDR. With class D IVDs having been required to transition by 26 May 2025 and with a long duration required for the conformity assessment process by Notified Bodies, there is a high risk of device shortages over the next few years. The proposed extension is intended to partly mitigate these issues while giving manufacturers and regulators more time to complete device certifications.

This workshop will provide an overview of the scope of the regulation and the proposed extension, with emphasis on class D IVDs and key considerations when preparing technical documentation and recommendations for stakeholders working towards a seamless transition.

Registration Fees & Deadlines

Member $0 | Nonmember $25 | Student: $10

Speakers

Stefan Burde, PhD
Director, Global Strategic Business Development IVD, TÜV SÜD

Stefan Burde, PhD is the director, global strategic business development IVD at TÜV SÜD, a leading full-scope Notified Body under the European Medical Device and In Vitro Diagnostic Regulations (EU) 2017/745 and (EU) 2017/746. Stefan holds a PhD in Pathology from the University of Rochester, and has over 13 years of experience in the in vitro diagnostic industry and over 9 years of Notified Body experience as an auditor, technical documentation reviewer, and strategic director. He has spoken extensively at international conferences on topics related to IVDR implementation and compliance.

Cancellations and Refunds

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 support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accept 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.

Proof of Attendance

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

Questions