First determine whether the product and intended use fall within MDR and identify the target market and commercial role. EU medical-device conformity duties follow the applicable scope and route; exemptions or special arrangements need their own assessment. A similar product's CE mark or an ISO 13485 certificate does not establish your device's regulatory status.
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.
Assess classification alongside sterility, measuring functions and reusable surgical instrument characteristics. Some Class I devices need body involvement limited to specific aspects. Self-declaration routes still require technical documentation and other obligations. Classification should not be determined from the product name alone.
The exact records for MDR How to Obtain It depend on the confirmed scope. Current, consistent and traceable information reduces avoidable revisions.
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