Depending upon the situation you need to register either the medical device or yourself as a manufacturer at the CIBG.

What needs to be registered?

  • the medical device: as a manufacturer you place class I medical devices on the Dutch market.
  • the manufacturer: you are a Dutch manufacturer and do not place class I medical devices on the Dutch market but in another member state of the European Economic Area (EEA).
  • the authorised representative: you are an authorised representative officially established in The Netherlands for a non-EEA manufacturer of class I medical devices.

Manufacturers of class I medical devices in sterile condition or class I medical devices with a measuring function need to be registered by a notified body of your choice, to assess the sterility and/or measuring function. This needs to be done before application at the CIBG.

In vitro diagnostics (IVDs)

Depending upon the situation you need to register either the IVD or yourself as a manufacturer at the CIBG.

What needs to be registered?

  • the medical device: as a manufacturer you place an IVD on the Dutch market. This obligation to notification applies to eachmanufacturer who places an IVD on the Dutch market for the first time, regardless of its registered place of business.
  • the manufacturer:
    • you are a manufacturer and place an IVD on the Dutch market. This obligation to notification applies to each manufacturer, regardless of your registered place of business within the EEA.
    • you are a Dutch manufacturer and do not place IVDs on the Dutch market but in another member state of the EEA.
  • the authorised representative: you are a an authorised representative officially established in The Netherlands for a non-EEA manufacturer of IVDs and place IVDs on the Dutch market.

Class IIa, IIb, III medical devices

As a manufacturer of these products you need to inform a notified body you are planning to place a Class IIa, IIb or III medical device on the European market. This also applies to the European authorised representative established in the Netherlands of a non-EEA manufacturer of a medical device falling within these classes. The CIBG does not register these applications.

An overview of notified bodies can be found here.

Custom made devices

Manufacturers of custom-made devices need to register their products at the CIBG.

What needs to be registered?

  • Custom-made devices are devices intended for exclusive use by a particular patient. Only devices that are manufactured within the Netherlands and are used by a patient in the Netherlands should be registered.
  • Devices that are made in the Netherlands but are intended for use by a patient outside the Netherlands, should not be registered.
  • For a non-EEA manufacturer of a custom-made device intended for the sole use by one particular patient living in the Netherlands, you have to designate an 'authorised representative' established in a Member State of the EU. If your authorised representative has his registered place of business in the Netherlands, he should register at the CIBG.

Application

For the Farmatec online service you need to purchase eHerkenning level EH2+. eHerkenning is provided by 6 accredited suppliers.
On the eHerkenning website you will find a step-by-step plan that will help you on your way to requesting a login tool.

At www.eherkenning.nl you'll find more general information in English.

Do you already have an eHerkenning login? Go directly to Login

Class I medical device

Include in your application product information (e.g. leaflet, manual, instructions for use) intended for the market which clearly indicates the category and classification of the medical device concerned.

IVDs

Include in your application product information (e.g. leaflet, manual, instructions for use) intended for the market which clearly indicates the medical use of the IVD concerned.

Procedure

If your application is not complete you will be requested to send additional information. When your medical devices meets the European requirements, you will receive a letter of confirmation.

Fee

It is legally established that manufacturers of medical devices must notify themselves and their products to the authority of the Member State in which they are established. This applies to both manufacturers and European authorized representatives of manufacturers from outside the EU. The CIBG charges the applicant € 200.00 per notification. The rate of € 200.00 is per notification of one product.

European directives

Medical Devices 93/42/EEC
Guidelines for the classification of medical devices (M2.4/1 rev.8)
In vitro diagnostics 98/79/EC