Medical Device Registration and Approval in Netherlands

General country-specific regulatory information is provided on this page for medical device registration and approval in Netherlands. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Netherlands, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Netherlands

REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In the Netherlands, devices are regulated by the Ministry of Health, Welfare and Sport Agency, CIBG Farmatec.

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.

TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

LICENSE VALIDITY: Licenses issued in the EU are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the European Union.

ADDITIONAL INFORMATION: On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives. The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

Last updated on October 22, 2018.

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