The Medical Device Regulation (MDR) 2017/745 has new stricter requirements that ask for various kinds of information to be indicated on the medical device labels. To comply with these requirements quickly and in a harmonised manner, MedTech manufacturers can use the present guidance on medical device symbols.
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There are more than 20 official languages in Europe, which creates a necessity to translate the label information into multiple languages, depending on where the medical device is being sold. Such a requirement can be easily dealt with by using symbols. Fortunately for MedTech manufacturers, using symbols on the medical device labels as an alternative to written language is permitted in the new MDR regulation: Annex 1, chapter III, article 23.1.
Symbols are efficient and internationally understood concepts allowing to convey the required information to the medical device users. All symbols part of the medical device labels must be easily recognisable and have at least 5 mm height. The use of one or several of the special symbols must be described in the Instructions for Use accompanying the specific medical device.
All medical device labelling requirements are described in chapter III of Annex I, chapter III of the MDR 2017/745. They outline what must be included on the medical device labels and serve as the legislative reference for the below-stated symbols.
#1. Medical device: This symbol indicated a product intended by the manufacturer to be used for human beings for specific medical purposes, such as diagnosis, prevention, monitoring, treatment or alleviation of disease.
#2. Medical devices that contain human blood or plasma derivatives
#3. Products containing a medicinal substance
#4. Medical devices with hazardous substances: This symbol indicates a medical device containing substances with carcinogenic, mutagenic, reprotoxic or endocrine-disrupting properties.
#5. Medical devices containing biological material of human origin (e.g. tissues, cells or their derivatives)
#6. Medical devices containing biological material of animal origin (e.g. tissues, cells or their derivatives)
#7. Medical devices supplied in a sterile condition: Manufacturers must specify the method of sterilization as well.
#8. Symbols for translation and repackaging: Economic operators other than the legal manufacturer must indicate on the medical device or, where that is unfeasible, on its packaging or Instructions for Use, the activity carried out together with their name, registered trademark, registered place of business and the address at which they can be contacted.
#9. A symbol indicating ‘single patient – multiple-use’ in the case of a medical device that is intended for single-use only, reuse on a single patient, and/or reuse on more than one patient.
#10. UDI symbol: This symbol is not mandatory, but it must be used when multiple data carriers are present on the medical device label.
Clever Compliance helps companies of any size meet the MDR requirements and get their products on the EU market. We help our clients perform a GAP analysis under the MDR, create valid technical documentation, register their products with the relevant market authorities, and any other part of the medical device CE certification process. So, if you need help getting your products on the EU market, get in touch with our team at [email protected].