Registration

Class I medical devices

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 each manufacturer who places an IVD on the Dutch market for the first time, regardless of his 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.

The European Directive 98/79/EEG describes a databank (Eudamed) for IVD-applications. Pending the establishment of this databank all manufacturers or authorised representatives have to register themselves and their products in each member state in which products are marketed. A single registration at the CIBG does not suffice.

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

The application form for new class I medical devices, IVDs or custom-made devices can be downloaded and printed.

It helps the registration of the medical device products if the notification is accompanied by the following information of the Medical devices (Directive 93/42/EEC and 90/385/EEC) and In vitro diagnostics (Directive 98/79/EC):

  • the (unique) productname(s)
  • the intended (medical) use
  • the GMDN- and/or the EDMS-code(s)
  • productinformation (user's guideline, etc.)
  • for IVD’s of a higher risk class (class A, class B, self-tests) the related CE-certificates (issued by a Notified Body) the Document(s) of Conformity

Send your application form (including the required documents) to:

CIBG
Farmatec-BMC
PO Box 16114
2500 BC The Hague
The Netherlands

The application can also be sent by email to: medische_hulpmiddelen@minvws.nl

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 reaction by mail or email.

European directives

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