Medical devices

Medical devices are categorised into four risk classes

Medical devices are categorised into four risk classes: I, IIa, IIb and III. These risk classes for medical devices are stipulated in the European directive on medical devices.
You have to submit notifications of medical devices and in vitro diagnostic medical devices (IVDs) or apply for a Free Sales Certificate online. You will also have to submit certain documents. To log in you need level 2+ eHerkenning.

New EU legislation into effect on 26 May 2021

The MDR implementation came into effect on 26 May 2021.
The date on which the IVDR is going to come into effect is 26 May 2022. In this notification you can read more about the new legislation.

Applying for the eHerkenning login

You can obtain an eHerkenning login from one of the 6 certified suppliers. On the eHerkenning website you can find a step-by-step plan that will help you apply for a login.
If you already have an eHerkenning login you should proceed immediately to Log in.

NB! Trade registration obligatory

Your business must be registered in the commercial register and have a registration number.
An existing registration can be changed on the commercial register website by selecting 'Registration and change' from the menu.