Hello,
We are Manufacturer of CT Scan machine . During an audit, auditor ask for justification for non applicability of directives other than EU 2017/745 such as PPE directive and so on (as listed in Classification summary table of document as attached in #3).
Is there any directive applicable to us other than EU MDR 2017/745.
Can anyone please provide me a sufficient justification for directives not applicable to us, so that we can add these in our technical documentation.