What kind of information needs to be indicated on the label of medical devices?
The Medical Devices Regulation (MDR) will shortly be applicable and will be asking for various sorts of information to be indicated on the label of medical devices. How can a manufacturer comply with such requirements within the short term and in a harmonized manner?
Having 24 official languages in Europe renders the use of symbols essential to convey the required information on the labels. Annex I, Chapter III, 23.2 of the MDR lies down what information the label must bear, varying from a simple wording “medical device’’ to the UDI carrier. The use of symbols on the label as an alternative to written language, when appropriate, is permitted by the MDR (Annex I, chapter III, 23.1.h).
The information is large and to ease manufacturers’ tasks MedTech Europe has issued symbol designs, titles and translations and proposes to use them internationally. However, they must be described in the Instructions for use, in line with the MDR 23.1.H, until they are not published in a harmonized standard.
Manufacturers are encouraged to use the following symbols, if needed for particular cases, always in the same order as shown below – with the aim to speed up user recognition and acceptance of the symbols and their meaning.
MedTech Europe proposed symbol designs:
Additionally, as an alternative to the text, the following symbols are also recommended to be used on the implant card (MDR Article 18):
As a matter of fact, the above symbols are published and available for use via the ISO website.
Carlos Francisco Marín Barrios
Regulatory Affairs Department
For further information kindly contact our experts.