Notifications

Existing notifications in NOTIS

If your product has already been notified in NOTIS, but not yet in EUDAMED, you must still register your product in EUDAMED.

There are two transitional periods for the mandatory registration in EUDAMED. These deadlines depend on when you place/have placed the medical device or IVD on the market. They are:

1. If you place the medical device on the market on or after May 28, 2026: You must register the medical device in EUDAMED before placing the first individual unit on the EU market.
2. If you placed the medical device on the EU market before May 28, 2026: You must complete the registration in the EUDAMED UDI/Device module before November 28, 2026.

Custom-made medical devices

In the Netherlands, registration is mandatory for manufacturers (and where applicable: including the authorized representative) of custom-made devices. The obligation to register is set out in Article 2 of the Ministerial Regulation.

You must complete this registration in NOTIS. More information about registering custom-made medical devices can be found on this page.

Once the information and required documents are complete, the processing time for a notification application is a maximum of 90 days.

Changes / Amendments

Confirmed product notifications that you have not yet processed in EUDAMED can still be changed online (product updates) in NOTIS up to and including November 28, 2026. You will also need to log in using eHerkenning for this. A change can consist of an amendment (WIJZ), conversion, or deregistration (AFM).

The processing time for a deregistration or amendment is a maximum of 3 months.