Language requirement and labelling of medical devices
Every medical device must be accompanied by the information necessary to:
- ensure that the device is used safely and correctly, with due allowance for the potential user’s level of education and knowledge;
- identify the manufacturer.
This information must be provided in the form of indications stated on the labelling and – if applicable – also on the display and in the directions for use.
Directions for use
Every medical device must be accompanied by directions for use, except where the medical device falls into class I or IIa and the device can be used safely without directions for use. This must be evidenced by the manufacturer’s risk analysis.
Medical Devices Decree
Under Article 6 (2) of the Medical Devices Decree, the information stated on the labelling and – if applicable – on the display and in the directions for use of medical devices (or parts thereof) supplied to patients, users and consumers must be in Dutch.
The requirements stated above do not apply to medical devices supplied solely to professionals who employ them in the course of their work (such as doctors and nurses). Since 11 April 2014, the Netherlands Health Care Inspectorate’s (‘IGZ’) policy has been that it suffices for the information on the devices to be provided in English, on condition that the person employing the device possesses an adequate command of English.
Exemption from language requirement
It is not necessary to apply to the Minister of Health, Welfare and Sport for exemption from the language requirement for products that will be used solely by professional users. Nor is it necessary to translate into Dutch the product names stated on the label or in the directions for use of any medical device.
The Health Care Inspectorate will take enforcement action if there is any violation of the prevailing legislation.