Should manufacturers adapt to the Notified Body's language, or should the NB adapt to the manufacturer's language? (both documentation and spoken language in audits).
I have always thought it was the former (manufacturers should adapt to the language accepted by the NB, usually including English, as they applied to that NB...), but recently someone told me confidently that there might exist a requirement (or recommendation?) for Notified Bodies to assign an auditor that speaks the same language as the client. For example, manufacturer from Italy and NB from the UK, the NB should assign an auditor that speaks Italian (doesn't really make sense to me).
What I found in MDR:
I have always thought it was the former (manufacturers should adapt to the language accepted by the NB, usually including English, as they applied to that NB...), but recently someone told me confidently that there might exist a requirement (or recommendation?) for Notified Bodies to assign an auditor that speaks the same language as the client. For example, manufacturer from Italy and NB from the UK, the NB should assign an auditor that speaks Italian (doesn't really make sense to me).
What I found in MDR:
- Annex VII (Requirements to be met by Notified Bodies) > 4.2 > (a) publish a publicly available description of the application procedure by which manufacturers can obtain certification from it. That description shall include which languages are acceptable for submission of documentation and for any related correspondence;
- Article 52 (Conformity assessment procedures) > 12. The Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 7 and 9 to 11 be made available in an official Union language(s) determined by that Member State. In the absence of such requirement, those documents shall be available in any official Union language acceptable to the notified body.
