Language requirement and labelling of medical devices
Language requirement for medical devices
All information intended for the patient and/or the user of a medical device, such as the label and instruction leaflet, must be in Dutch. An exemption can be made if three criteria are met in full:
- the product is to be used by medical specialists;
- users receive special training in the use of the device in question;
- the product is to be used regularly, allowing for a routine to be established.
A request for exemption should be submitted to
Pharmacy and Medical Technology Unit
P.O. Box 16114
2500 BC The Hague, the Netherlands
The language requirement is established by Article 6, Section 2 of the Medical Devices Decree. Exemption may be granted further to Article 8 of the Medical Devices Act.
Labelling requirements for medical devices
The minimum information requirement for a label is:
- name, street address, postcode, town/city and country of the manufacturer’s/representative’s registered office;
- the name of the device, its intended purpose and (if possible) an illustration;
- further instructions and warnings.
Information relating to the safe use of the device must, where possible and useful, be on the device itself, on the individual packaging of each unit or, where circumstances demand, on the sales packaging. If it is not possible to include information on the unit packaging, that information must be included in the instructions for use accompanying each device or batch of devices.
The packaging of each medical device must include instructions for use. An exception is permitted in the case of Class I and IIa devices, if the safe use of such devices does not require specific instructions. It is not permitted to issue the instructions solely by means of an alternative channel such as the internet, although this can be a useful supplement. Labelling requirements are described in the Part 1, Section 13.3 of the annex to the Medical Devices Decree.