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Notifications

There are three types of notifications:

  1. notifications for what are considered new medical devices and in vitro diagnostic medical devices that are being marketed in Europe for the first time. This is the correct website to do this;
  2. notification of clinical research with medical devices. This type of notification can be submitted to 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. You can find more information on the Health and Youth Care Inspectorate website.

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

Existing notifications in NOTIS regarding MDD-compliant Class I products and system/procedure packs containing an MDD-compliant Class I medical device will remain valid for the periods outlined below.

  • 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 for the conformity assessment procedure: your notification will be valid until 31 December 2028 at the latest, provided your product remains compliant with certain conditions (see legacy device below).
  • If you withdraw an MDD-compliant product, you are obliged to withdraw your notification.

Notifications for Legacy Devices

Class I devices under the MDD or IVD class other for which:

  • the MDD/IVDD directives do not mandate the involvement of a notified body for the conformity assessment procedure;
  • a declaration of conformity has been drawn up in accordance with the MDD/IVDD before the date of application of the MDR/IVDR;
  • the MDR/IVDR do mandate the involvement of a notified body for the conformity assessment procedure.

These products fall under the category of legacy devices.

It is possible to register these legacy devices (certain MDD class I until 31 December 2028 and IVDD (other) products until May 2025), which fall under the transitional provisions of the IVDR /MDR (Art. 110/120), with Farmatec in NOTIS.

Registration is only possible if:

  • the medical device are compliant with the directives on medical devices (MDD) and were put onto the market prior to 26 May 2021, the date of application of the MDR;
  • no significant modifications may be introduced to the device;
  • the manufacturer introduced a quality management system by 26 May 2024 in accordance with Article 10(9) MDR;
  • the manufacturer or authorised representative submitted a formal request for a conformity assessment from a notified body by 26 May 2024;
  • the notified body and the manufacturer must have signed a written agreement by 26 September 2024 to have the medical device certified in accordance with the MDR;
  • the medical device concerns a device that is compliant with the directives on medical devices (MDD) and will be upclassified under the MDR (in accordance with Article 120(3) MDR).

Notification of a legacy device previously registered with another EU Member State authority

  • the product as in the transition period described in the MDR/IVDR must be adopted by a European authorised representative registered in the Netherlands. The applicant must provide a declaration to this end;
  • the authorised representative registered in the Netherlands must include in the notification request a declaration of conformity drawn up before the date of application of the MDR/IVDR;
  • the product must have been adopted from a European authorised representatives from another EU Member State. The applicant must submit proof of registration showing that the product was registered with an EU Member State authority before the date of application of the MDR/IVDR.

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 can be found on this page.

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.

You will need an SRN to notify your medical device or IVD in EUDAMED. You can find more information about applying for an SRN here.

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 on this page.

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.

If your product is an IVDD-compliant in vitro diagnostic medical device (IVD self-test, List B and List A) that is categorised as a higher risk class under the IVDR, you must register your IVD product in EUDAMED or register it in NOTIS until EUDAMED has become fully operational.
The required documents are available on this page.

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 ‘sterile’ or 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.

You will need an SRN to notify your medical device or IVD in EUDAMED. You can find more information about applying for an SRN here.

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.