To comment on Peters' answer:
True, you have to ensure that the labeling (incl. IFU) is written understandible for the end user.
As the EU covers 24 official languages, you have to ensure that at least the IFU is covering them if you would like to place the device on all EU (country) markets.
Packaging labels can be designed harmonized to prevent unnecessary translations by using standardized symbols which are covered by ISO 15223-1 (available in harmonization to (EU) MDR 2017/745).
Hope this information helps you to get prepared!
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Anja Abelmann
Göttingen
Germany
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Original Message:
Sent: 19-Oct-2022 08:02
From: Peter Reijntjes
Subject: Labeling EU MDR
Hi Shika,
the MDR is pretty clear about this; in the obligations of the Manufacturer in article 10, it is stated in sub-article 10.11 that "Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient".
This concerns the IFU, the label on the device, and if not practicable or appropriate on the label of the primary packaging (including the packaging which maintains the sterile condition) of each unit and/or the packaging of multiple devices.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands
Original Message:
Sent: 18-Oct-2022 20:09
From: Shikha Malik
Subject: Labeling EU MDR
Hello,
I would like gain some knowledge on the language requirement for the labels under EU MDR . Do we need to translate the label and IFU both in EU languages? Or, just providing the translated IFU would suffice the requirement.
If we need to translate labels as well. Is it the pouch label or carton label?
Thank you for your support in advance.
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Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
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