Since there are 24 official languages in Europe, there is a need to translate information given on the labels into different languages. By using symbols as an alternative to written languages, these requirements can be met easily. In its Annex I, chapter III, 23.1.h., MDR has permitted the manufacturers to use the symbols in the placement of written languages.
There are many benefits of using symbols, such as efficiency and cost reduction. The symbols are also helpful in conveying internationally understood concepts and information to the medical device’s user.
Required Processes for Symbol Validation
The ideal height for all the symbols is 5 mm, the same minimum height required for the CE mark. Once validated, these symbols will ensure the devices’ compliance with the MDR, and they will also communicate the necessary information to the end-users, i.e., healthcare professionals and the patients.
How to Use These Symbols?
While in the EU, these symbols must be described in IFUs (Instructions for Use) as per MDR 23.1.h until they are published in a harmonized European standard.
Legislative References Used in MDR
The label’s contents, i.e., what must be included on the label, are outlined in Annex I, chapter III, paragraph 23.2 of the EU MDR. The paragraph is about “Information on the label,” and it is a legislative reference to the following symbols:
- Medical Device: MDR, Annex 1, 23.2, q
- Contains human blood or plasma derivatives: MDR, Annex 1, 23.2, e
- Contains a medicinal substance: MDR, Annex 1, 23.2, e
- Contains hazardous substances: MDR Annex 1, 23.2. (f)
- Contains biological material of human origin: MDR, Annex 1, 23.2, e
- The symbol used for this purpose shows whether the medical device (to which the symbol is associated) contains tissues, cells, or their derivatives of human origin
- Contains biological material of animal origin: MDR, Annex 1, 23.2, e
- The symbol used for this purpose shows whether the medical device (to which it is associated) contains tissues, cells, or their derivatives of animal origin
- Contains a medicinal substance: MDR, Annex 1, 23.2, e
- Sterilized using vaporized hydrogen peroxide: MDR, Annex I, 23.2, I
- Translation and Repackaging: The requirements regarding translation and repackaging are given in MDR Article 16, Point 3. According to this article, these activities must be mentioned either on the device or its packaging or n an accompanying document
- Single Patient – Multiple use
- TSQ and E recommends using the present symbol for the meaning of ‘Single Patient – multiple use.’ This symbol is part of ISO 152231 and part of ISO 7000’s database. References given in ISO and IMDRF documents
- Single sterile barrier system
- Double sterile barrier system
- Single sterile barrier system with protective packaging inside
- Single sterile barrier system with protective packaging outside
- Importer and Distributor
- MDR imposes new obligations on the importers and the distributors. For instance, Article 16 of MDR mandates the importers and the distributers to indicate their activities on the labels regarding repackaging and translation. The purpose of these symbols is to facilitate MDR compliance
- Unique Device Identifier: MDR 2017/745-Annex VI, Part C The UDI System, 4. UDI Carrier, 4.5
- Contains nanomaterials
- MDR emphasizes the addition of nanomaterials in medical devices (as indicated in Annex I GSPR, chapter II, Art. 10.6.). Although it is not a formality to show the information regarding nanomaterials on the label, creating a separate symbol for this purpose can b helpful.
Annex I: Symbol Designs & Titles
The symbols and their meanings are given here in the English language. However, Annex I of EU MDR also contains their translations in the 24 official languages of Europe.
Notes for the Manufacturers
- The symbols not needed by the manufacturers can be dropped from the list. However, it is recommended to always place the symbols according to the list given above. If the manufacturer always follows the same order of placement, he will be able to speed up the user recognition and acceptance of the symbols and their meaning
- To avoid confusion among the users, the manufacturers should ensure that they are using the same titles as given in ISO 7000 or ISO 15223-1:2021.
Need Help With Medical Device Labeling?
If you are a medical device manufacturer looking for EU MDR-complied labels for your products, then TSQ and E can help you with the process. Our experts can provide you with consultancy to prepare the correct labels for your medical devices while fulfilling all the regulatory requirements set forward by EU MDR. To get your labels, contact us today via our website tsquality.ch.
