Citation de
Lise V le 30 novembre 2023, 11 h 47 min
Bonjour @marimari123456789,
Comme expliqué dans le guide MDCG 2019-9 Rev.1, on retrouve cette exigence directement dans l'article 32 du MDR :
Translations to other EU languages
No single language will be understood by all intended users and patients in the EU – see the European Survey on Language Competences initiated by the European Commission (4). In order to meet the requirement in the MDR that the SSCP shall be written in a way that is clear to the intended user and, if relevant, to the patient , the SSCP should be translated into the languages accepted in the Member States where the device is envisaged to be sold. This is by analogy with the requirement for an IFU. Note that Member States may have different language requirements for an IFU depending on whether the information is intended for health care professionals or for patients. The SSCP part intended for patients should be provided in all the languages required for IFUs intended for patients in the Member States concerned.
Bonjour @marimari123456789,
Comme expliqué dans le guide MDCG 2019-9 Rev.1, on retrouve cette exigence directement dans l'article 32 du MDR :
Translations to other EU languages
No single language will be understood by all intended users and patients in the EU – see the European Survey on Language Competences initiated by the European Commission (4). In order to meet the requirement in the MDR that the SSCP shall be written in a way that is clear to the intended user and, if relevant, to the patient , the SSCP should be translated into the languages accepted in the Member States where the device is envisaged to be sold. This is by analogy with the requirement for an IFU. Note that Member States may have different language requirements for an IFU depending on whether the information is intended for health care professionals or for patients. The SSCP part intended for patients should be provided in all the languages required for IFUs intended for patients in the Member States concerned.
