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.
In the Netherlands, you are legally obliged to register medical devices or IVD’s if you are:
- a manufacturer or a European authorized representative established within the Netherlands and place a class I medical device supplied under your own name on the European Market (Article 5 (1) of the Medical Devices Decree);
- a manufacturer or European authorized representative established within the Netherlands and place of a custom-made medical device on to the European market (Article 5 (2) and Article 12 of the Medical Devices Decree);
- an assembler established within the Netherlands and place a system or treatment package on the European market (Article 5 (2) and Article 10 of the Medical Devices Decree and Article 5a (1) of the Active Implantable Medical Devices Decree);
- a manufacturer or European authorized representative established within the Netherlands and place an IVD on the European Market
