The requirements for device classification in new European Medical Device Regulation (EU MDR) are essentially the same as those in the current Medical Device Directive (MDD).

The obligation to assign a classification to all devices is contained in Article 51 in the new EU MDR (replacing Article 9 of the current MDD). The rules to be followed in determining the classification are contained in Annex VIII in the new EU MDR (replacing Annex IX of the current MDD. The new Article 51 does however clarify, that where a Manufacture and Notified Body cannot agree on a classification, the Competent Authority of Manufacturer makes the final determination. While this is the established practice under the MDD it was not specifically stated in the MDD.

Comparing the EU MDR Annex VIII to the current MDD Annex IX:

The new Annex VIII still contains a few definitions but the remainder have been moved to the new dedicated Article on Definitions, Article 2.

The implementing rules are broadly the same as in the current MDD Annex IX. Below is a summary of the more significant changes but this is not an exhaustive list;

Rule 3 (non-invasive devices), substance devices have been included.

Rule 8 (class IIb implants), more will be class III in the future.

Rule 9 (active devices), more will be class III in the future.

Five new rules have been added to the new Annex VIII;

Rule 11, concerning software used to take decisions.

Rule 19, concerning nanomaterials.

Rule 20, concerning inhalers.

Rule 21, concerning substances.

Rule 22, concerning active devices with a diagnostic function.

The current MDD Rule 18 (blood bags) has been removed from the new EU MDR.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.