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. This makes it possible to identify the medical device and its manufacturer and ensures that the medical device is used safely and correctly. The information on the label and in the instructions for use must be adapted in line with the training and knowledge of future users. This information must also be available on the manufacturer's website.
Where appropriate, the information supplied by the manufacturer shall take the form of (internationally recognised) symbols. This will usually make the information more easily accessible, including for people without a good command of the language.
These and other general requirements which relate to information which the manufacturer must provide can be found in: Annex I on general safety and performance requirements of the MDR (Chapter III, Article 23.1) and the IVDR (Chapter III, Article 20.1)
Labelling requirement
The information required on the label shall be provided on the device itself and must be indelible and clearly legible. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit and/or on the packaging of multiple devices.
What does the label state?
Annex I (general safety and performance requirements) of the MDR (Chapter III, Article 23.2) and the IVDR (Chapter III, Article 20.2)) sets out item by item wat (if applicable) must appear on the label of a medical device or IVD.
Address of the manufacturer or authorised representative
The manufacturer's (physical) address must be stated on the label. Just a postcode or web address (digital address) is not enough. It has to be possible to find the manufacturer's exact location using the address details.
If the manufacturer is not located in the EU but wants to sell the medical devices within the EU, the manufacturer in question must designate a European authorised representative. The official address details of this authorised representative must then be displayed on the label, together with the manufacturer's details.
Rules for instructions for use and advertisements
Every medical device must be accompanied by instructions for use, except medical devices in classes I or IIa or exceptions with regard to IVDs and devices which can be used safely without instructions for use. This must be evidenced by the manufacturer's risk assessment.
According to article 7 of the MDR, it is prohibited to mislead the user, or the patient regarding the performance of the device. This in relation to e.g. labelling, instructions for use as well as advertising of devices. In advertisements it is prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance.
What should be stated in the instructions for use?
Annex I (general safety and performance requirements) of the MDR (Chapter III, Article 23.3) and the IVDR (Chapter III, Article 20.3)) describes exactly which items must be included on the instructions use of a medical device or IVD.
The format of the instructions for use
The instructions for use can be issued to users in non-paper form, for example electronically. Currently this is only possible subject to the conditions included in Regulation (EU) no. 207/2012. Extra information on this may be available at a later date in the MDR/IVDR.
Language requirements
In the Netherlands the labels and instructions for use must be written in Dutch. This requirement is contained in the first paragraph of Article 1 of the Ministerial Decree.
However, medical devices and IVDs which are only supplied to professional users (such as doctors, laboratory employees and nurses) can have a label and instructions for use in English. This is stated in the second paragraph of Article 1 of the Ministerial Decree.
The manufacturer must be certain that only professionals with a sufficient command of English will be using the product. The manufacturer is required to keep a watch on this matter by means of the legally required post-market surveillance system.