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ViewAttendees 16

IVD

Domain: Product Development & Registration

Knowledge Area: Process & Procedures

Conformity Assessment of Class D Devices: What is the Current Status?

Thursday, May 11, 2023
16:45 – 17:45 CEST
Location: Pearl 2

Supported By
Description: Regulation EU 2017/746 defines a complex conformity assessment process for class D devices; in addition to a notified body, this process involves an EU reference laboratory and, for the first certification for a type of device and in absence of Common Specifications (CS), an additional assessment by the IVD Expert Panel.
Furthermore, post certification, the performance of individual batches should also be verified.
The expert panel has been operational since September 2021,the first CS have become available in July 2022, however CS for additional class D devices are still in development.
U reference laboratories have not been designated yet and it is possible that, once designated, they do not include all class D devices.

This means the conformity assessment process for class D devices are occurring while the regulatory infrastructure is not fully implemented.

Key points to be discussed in this panel are:
What is the current status of conformity assessments for this class of devices?
How is performance verification being managed?
Is the transition to the IVDR going to be completed before the end of the transition period in May 2025?

Representatives of the EU Commission, Notified Bodies, diagnostic laboratories, expert panel and In-Vitro Diagnostics manufacturers will share their views, experience and strategies to complete conformity assessment process for class D devices with the currently existing regulatory infrastructure as well as provide an update on the future developments of the regulatory infrastructure. The panel discussion will be moderated by an independent consultant.

By joining this panel discussion, participants will be able to ask questions on the certification process and subsequent performance evaluation of class D IVDs to each of the panellist.
Additional participants not included in the participant list are: Maurizio Suppo, VP QARAD, Belgium; Dr. Stefan Scheib Network Lead Core Lab, Roche Diagnostics GmbH, Germany (To be confirmed)

Learning Objectives:

  • Upon completion, participants will acquire a clear understanding of the current status of the transition to the IVDR and ongoing challenges for class D devices.
  • Upon completion, participants be able to support the completion of the conformity assessment process of class D IVDs under the IVDR and subsequent performance evaluation
  • Upon completion, participants will be able to take informed decisions on the completion of the conformity assessment process of class D IVDs under the IVDR.