Does the MDR article 10 (14) needs to be documented word for word in a Procedure?

[David Hong]

Recently, our external auditor picked up an issue with our ISO procedure (i.e., Communication procedure, Change Management procedure and Complaints and incidents management etc.), about not stating word for word as per MDR Art 10 (14), Manufacturer, upon request by a competent authority, provide it with all the information and documentation (e.g. risk management file) necessary to demonstrate the conformity of the legacy device, in an official Union language determined by the Member State concerned (see MDR Art. 10 (14)). Is this mandatory to be documented word for word?

 

[chris1price]

The external auditor is being overzealous here, what was the actual finding?

Article 10 lists "General Obligations", I would expect that somewhere in your systems you say you can provide the information requested by the CA in the appropriate language. It doesn't need to be more specific than that.