The legal manufacturer remains responsible for MDR conformity, technical documentation, the EU declaration and post-market obligations. A notified body performs the tasks required by the device's class and selected route; competent authorities have regulatory oversight roles. Kayra coordinates preparation. Contract manufacture and own-brand selling require explicit allocation of records and responsibilities.
Determine how the device is marketed and each party's MDR role. Own-brand supply may create manufacturer duties; assess specific contractual arrangements against the relevant provisions. Clarify technical file access, quality systems and post-market responsibilities. Do not treat the factory's certificate as transferring all your duties.
The exact records for MDR Who Manages the Process? depend on the confirmed scope. Current, consistent and traceable information reduces avoidable revisions.
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