There are three types of notifications:
- The notification 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.
- The notification 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 [Centrale Commissie Mensgebonden Onderzoek] (CCMO).
- The notification of incidents and near-incidents with medical devices and IVDs for which the Health and Youth Care Inspectorate [Inspectie Gezondheidszorg en Jeugd] (IGJ) is responsible.
You have to submit notifications of class I medical devices and IVDs online. You will also have to submit certain documents. To log in you need at least level 2+ eHerkenning.
Before giving notice of products, you should check that this has not already been done, for example under a different trade name. If this is the case, you should submit evidence of this previous notification.
Who was allowed to notify?
A manufacturer established in the Netherlands, or an authorised representative established in the Netherlands of a non-EU manufacturer, can submit notifications of medical devices and IVDs.
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.
Medical devices are categorised into four risk classes: I, IIa, IIb and III. These risk classes for medical devices and are stipulated in the European directive on medical devices. You can find a clarification of these classification rules in the Guidelines for the classification of medical devices.
In vitro diagnostic medical devices
IVDs are classified in a high-risk and low-risk class:
• High-risk products are placed on lists A or B in accordance with section 2 of the In vitro diagnostic medical devices decree or are self tests for use at home.
• All other products fall into the low-risk class.
In order to submit notifications of products you must upload a number of documents along with the online application. Without these documents we will not be able to process your application.
Find out here which documents you have to add in order to submit notifications of your products.
The law stipulates that manufacturers of medical devices must register themselves and their products with the competent authority in the member state in which they are established. This applies both to manufacturers and to the European authorised representatives of manufacturers established in the Netherlands. A fee of € 200 applies for each product (line) you want to submit notifications for. The same applies to products for which notifications have already been submitted in another EU country.
If the details and the necessary documents are complete, a notification application will be processed within no more than 90 days.
Confirmed product notifications can be changed online (product mutations). To do so you will once again have to log in with eHerkenning. A change can consist of a change (WIJZ), conversion, deregistration (AFM), or reregistration (OPN) if the product has previously been deregistered.
A deregistration or change will be processed within no more than 3 months.