IVDR Knowledge Test

The deadline for the new EU In Vitro Diagnostic Medical Device Regulation (IVDR) is fast approaching. Applications must be approved by May 26, 2022, or for some products, CE marking will become invalid. If your company has a qualifying product on the market and has not yet started the application process, now is the time.

Answer the 15 questions below to help determine your knowledge gaps in key areas of the IVDR.

True or false? If a product is currently self-certified, it will continue to be self-certified under IVDR.

True or false? Only new products are subject to IVDR. Any product already on the market is grandfathered in.

Which of the following products are subject to the IVDR?

Which of the following classes must work with a notified body under IVDR?

True or false? Performance evaluation reports are required for classes C and D only.

The time frame for reporting serious incidents via EUDAMED is:

True or false? All companies with devices that fall under IVDR must have a designated Person Responsible for Regulatory Compliance (PRRC).

The qualifications for PRRCs include:

True or false? The device manufacturer and every other participant in the supply chain (distributors, importers, reagent suppliers, etc.) are regulated under the IVDR.

True or false? A previously approved label is accepted under the IVDR.

True or false? The IVDR requires devices of all classes to participate in a Unique Device Identifier (UDI) system.

A device that was placed on the market prior to May 2022 under the IVDD with a certification expiration date of 2026 can stay on the market until:

Unannounced inspections for classes B, C, and D must happen every:

True or false? Data from existing studies used for IVDD certification will be sufficient under the IVDR.

The average product review time by the Notified Body is:

Thank you for taking the assessment. Please submit the form to see your results.