What needs to be registered?

Medical Devies

The medical device: as a manufacturer you place class I medical devices on the European 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. 

What needs to be registered?

In vitro diagnostics (IVDs)

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: (1) 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. (2) 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.

Application Procedure

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.

How ecerep can help you?

We submit an application for the competent authority on behalf of you 

 

once the application is completed and accepted. the competent authority will issue a letter of confirmation

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A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives/Regualtions

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