Notifications

There are three types of notifications:

  1. notifications of 'new' medical devices and in vitro diagnostic medical devices (IVDs) which are being marketed for the first time in Europe. Farmatec is responsible for performing this task.
  2. notifications of clinical trials with medical devices. Since 1 October 2020 it has been possible to submit these notifications via the Central Committee on Research Involving Human Subjects (CCMO).
  3. reports regarding incidents (MIR) or corrective actions (FSCA) in relation to medical devices and IVDs. This comes under the remit of the Health and Youth Care Inspectorate.

Notifying party

Netherlands-based manufacturers or their authorised representatives are obliged to submit notifications when marketing medical devices or procedure packs that belong to one of the following classes:

  1. Class I Medical Devices;
  2. Custom-made Medical Devices;
  3. In Vitro Diagnostic Medical Devices (IVD) (all risk classes).

Classification

Class I medical devices


Medical Device Directive (MDD) Notifications

If your product is categorised as a Class I medical device in accordance with the MDD, you will no longer be able to use NOTIS to register your medical device.
If your procedure pack is categorised as a Class I medical device in accordance with the MDD, you will no longer be able to use NOTIS to register your procedure pack.


Existing MDD notifications in NOTIS

Existing notifications in NOTIS regarding MDD-compliant Class I products and procedure packs containing an MDD-compliant Class I medical device will remain valid for the periods outlined below.
•    Your notification will no longer be valid if it relates to an MDD-compliant Class I medical device that is not upclassified under the MDR.
•    If your product is categorised as a Class I medical device under the MDD and has a declaration of conformity that was drawn up prior to 26 May 2021 and the MDR mandates involvement of a notified body: your notification will be valid until 26 May 2024 at the latest, provided your product remains compliant with the MDD and no significant modifications are made to it.
If you withdraw an MDD-compliant product, you are obliged to withdraw your notification.


Medical Device Regulation (MDR) Notifications

•    Existing NOTIS notification:
If you believe that your existing MDD notification meets the MDR requirements, you must enter your existing registration for an MDR-compliant Class I medical device in EUDAMED, or use a change request to temporarily amend your NOTIS notification until EUDAMED has become fully operational.

•    New registration:
If your medical device is categorised as Class I under the MDR, you must register your product in EUDAMED or register it in NOTIS until EUDAMED has become fully operational. The required documents are listed under this link.

The government encourages parties to complete registrations for MDR/IVDR-compliant procedure packs, Class I medical devices and in vitro diagnostic medical devices in EUDAMED. If you are a Netherlands-based manufacturer or its authorised representative and do not choose this route, you are required to complete a national registration in NOTIS.


Custom-made medical devices

In the Netherlands, manufacturers (and their authorised representatives, if applicable) are required to register custom-made devices. This registration obligation has been laid down in Article 2 of the Ministerial regulation.


This registration is completed via NOTIS. More information on registering a custom-made medical device is available here.


In vitro diagnostic medical devices (IVD)


In Vitro Diagnostics Directive (IVDD) Notifications

If your product is an in vitro diagnostic medical device in accordance with the IVDD, you can register your IVD product or procedure pack containing an IVDD-compliant IVD in NOTIS until 19 May 2022.

Is your product an in-vitro diagnostic medical device in accordance with IVDD (IVD self-test, List B and List A) and is it listed in a higher risk class of the IVDR? Please register your IVD product in EUDAMED, or in NOTIS until EUDAMED is fully functional.

The required documents are listed under this link.

Existing IVDD notifications in NOTIS

Existing MDD notifications in NOTIS regarding IVDD products and procedure packs will remain valid for the periods outlined below.
•    If your product is an IVDD-compliant in vitro diagnostic medical device that is categorised as risk class A ‘non-sterile’ under the IVDR, your notification will be valid until 26 May 2022.
If your product is an IVDD-compliant in vitro diagnostic medical device that is categorised as a higher risk class under the IVDR, the following transitional periods will apply on the proviso that your product remains compliant with the IVDD and no significant modifications are made to it:
•    If your product is an IVDD-compliant in vitro diagnostic medical device that is categorised as risk class D under the IVDR, your notification will be valid until 26 May 2025.
•    If your product is an IVDD-compliant in vitro diagnostic medical device that is categorised as risk class C under the IVDR, your notification will be valid until 26 May 2026.
•    If your product is an IVDD-compliant in vitro diagnostic medical device that is categorised as risk class A ‘sterileor B under the IVDR, your notification will be valid until 26 May 2027.
•    Your existing notification for a procedure pack containing an IVDD-compliant IVD subject to one of the transitional periods outlined above will be valid until the date stipulated.


If you withdraw an IVDD-compliant product, you are obliged to withdraw your notification.


In Vitro Diagnostics Regulation (IVDR) Notifications


•    Existing NOTIS notification
If you believe that your existing IVDD notification meets the IVDR requirements, you must enter your existing registration for an IVDR-compliant IVD in EUDAMED, or use a change request to temporarily amend your NOTIS notification until EUDAMED has become fully operational.

•    New registration
If your product qualifies as an IVD under the IVDR (all risk classes), you must register your product in EUDAMED. Alternatively, you can register it in NOTIS until EUDAMED has become fully operational.


The government encourages parties to complete registrations for MDR and IVDR-compliant procedure packs, Class I medical devices or in vitro diagnostic medical devices in EUDAMED. If you are a Netherlands-based manufacturer or its authorised representative and do not choose this route, you are required to complete a national registration in NOTIS.


Costs

It is specified in law that manufacturers of medical devices must register their company and products with the competent authorities in the Member State where they are established. This applies to manufacturers as well as their European authorised representatives based in the Netherlands. Each product (entry) you wish to notify through NOTIS will incur a fee of €200. This also applies to products that were already registered in another EU country.
There is no fee to notify a product in EUDAMED.


Processing period

Once all information and required documents are present, it can take up to 90 days to process a notification request.


Changes

Confirmed product notifications can be amended online (product modifications). To be able to do this, you will once again need to log in using eRecognition. An amendment can be a modification (WIJZ), conversion, de-registration (AFM) or re-registration (OPN) if a product was previously de-registered.

De-registration or modifications can take up to 3 months to process.