Are there equivalent classifications to FDA Class I and II viewers under EU MDR?

Under the MDR, the situation is less clear than under FDA regulations. The MDD borderline manual suggests that a PACS or viewer only used for storing, archiving, and viewing images (without processing like 3D rendering or calculations) may not be considered a medical device. However, with the MDR, there is no updated borderline manual yet. The most relevant guidance (MDCG 2019-11) says to wait for new guidance.

For now, if your viewer truly does nothing beyond storing, archiving, and viewing (with no processing or manipulation), you might be able to justify releasing it as a non-diagnostic viewer not classified as a medical device, but this is based on previous MDD guidance. Once new MDR-specific guidance is published, this could change.

Some manufacturers have classified viewers as Class I devices under MDR, and there are even examples of Class I viewers in EUDAMED. However, there are also Class IIb PACS, so the classification depends heavily on the intended use and functionalities. You should be prepared to provide a solid rationale for your classification approach.