Requirements for labelling, instructions for use and language
Each medical device and each in-vitro diagnostic device (IVD) must be accompanied by a clear label, instructions for use and, where applicable, a display. Clear information means information that enables the device to be used safely and correctly and that is appropriate to the education and knowledge of the potential user.
Wherever possible, a manufacturer must also present the information in symbols. This will usually make the information more easily accessible, including for people without a good command of the language.
Every medical device and IVD must be provided with a label. For medical devices article 13.3 of Directive 93/42/EEC, Annex 1 (Essential Requirements), sets out what (if applicable) must be stated on the label. This includes the physical address of the manufacturer. For IVDs these requirements can be found in Directive 98/79/EC, article 8.4 of Annex I.
Rules for instructions for use
Every medical device must be accompanied by instructions for use, except medical devices in classes I or IIa provided that the device can be used safely without instructions for use. This must be evidenced by the manufacturer’s risk analysis. Article 13.6 of Directive 93/42/EEC, Annex I (Essential Requirements), sets out item by item what (if applicable) must appear in the instructions for use.
The same applies to IVDs. Instructions for use must accompany or be included in the packaging of one or more devices. In duly justified and exceptional cases no such instructions for use are needed for a device if it can be used properly and safely without them. Article 8.7 of Directive 98/79/EC, Annex I (Essential Requirements) sets out which particulars the instructions for use of an IVD must contain.
In the Netherlands, labels and instructions for use must be in Dutch. This requirement is contained in Article 6 (2) of the Medical Devices Decree (Dutch) and article 6 of the In-vitro Diagnostic Medical Devices Decree (Dutch). It covers devices used widely, not those only used by health care professionals.
Medical devices and IVD's supplied only to professional users (such as doctors, nurses and laboratory professionals) may be accompanied by instructions for use in English only. The manufacturer must make sure that the product will be used only by professional users with a sufficient command of English. The manufacturer is required to keep a watch on this matter by means of the legally required post-market surveillance system. A manufacturer that discovers that the product is being used by non-professional users or by professional users without a sufficient command of English must provide the information in Dutch.