Are your CE marked medical devices up to date with the latest standards?

The European Commission published updated lists of European harmonized standards for the medical devices directives (Medical Devices Directive, Active Implantable Medical Devices Directive and In Vitro Diagnostics Directive). Manufacturers of CE marked medical devices should check if the European harmonized standards that they have used during the conformity assessment are still valid, or whether they have been updated by these lists.

Standards that have been updated cannot be used to prove CE compliance from the date that the new version of standard comes into force. The standard update does not affect devices already placed on the market. But new for new batches the new version of updated standards should be used.

The updated lists of European harmonized standards can be found here:

Leave a Comment

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