Medical devices and in vitro diagnostic medical devices

Medical devices (MD) and in vitro diagnostic medical devices (IVD) have been grouped into risk classes. These risk classes are defined in law and have been laid down in:
Council Directive 93/42/EEC MDD  and Directive 98/79/EC IVDD

-    MDD risk classes (from low to high risk): I, IIa, IIb and III.
•    IVDD risk classes (from low to high risk): List A, List B, self-test and IVD other.

•    Regulation (EU) 2017/745 MDR and Regulation (EU) 2017/746 IVDR
-    MDR risk classes (from low to high risk): I, Is, Im, Ir, IIa, IIb, III;
-    IVDR risk classes (from low to high risk): A, B, C, D.
In due course, the European Regulations (MDR and IVDR) will replace the European Directives in full.


MDR: all medical devices brought onto the European market must comply with the MDR with effect from 26 May 2021, including medical devices that have been on the market for years. Article 120 of the MDR, however, contains a number of transitional provisions that grant extra time to achieve compliance with the MDR requirements for specific cases.
IVDR: all in vitro diagnostic medical devices brought onto the European market must comply with the IVDR with effect from 26 May 2022, including IVD that have been on the market for years. Regulation (EU) 2022/112, however, contains a number of transitional provisions that grant extra time to achieve compliance with the MDR requirements for specific cases.


New EU Regulation on IVD to take effect on 26 May 2022

The IVDR will enter into force on 26 May 2022. This will have an impact on existing notifications. Information on how your existing registrations will be affected can be found on the Notifications page.
The entry into force of the IVDR also changes the process for requesting export declarations. Please see the Export Declarations page for more information about export declarations.


Notification

Dutch manufacturers and Netherlands-based authorised representatives of non-EU manufacturers are required to submit notifications in respect of medical devices and in vitro diagnostic medical devices belonging to specific risk classes. Please see the Notifications page for more information.
Notifications for a medical device or an in vitro diagnostic medical device and requests for export declarations must be submitted online. You will also need to include the required documents. To be able to log into NOTIS, you will need a Level 2+ eRecognition token.


Requesting an eRecognition login token

You are responsible for obtaining an eRecognition login token from one of 6 recognised issuers. The eRecognition websites provides a step-by-step plan to get you started with your request for a login token.
Users who already have an eRecognition login token: Browse directly to Inloggen (Login)


Please note that registration is mandatory for establishments

Your company must be entered in the Commercial Register and have an establishment number.
Existing registrations can be amended via the Commercial Register website, under the menu option ‘Inschrijven en wijzigen’ (Registration and amendments).