Build MDR technical documentation around the device's intended purpose and justified classification. Include design and manufacturing information, risk management, general safety and performance requirements, verification and validation, clinical evaluation, labels and instructions, and post-market documentation. Annexes II and III frame the file; ISO 13485 certification alone does not supply device-specific clinical evidence.
Explain relevance to intended use and technical and biological characteristics. Assess equivalence conditions and data access; use for the same disease alone is insufficient. Develop a device-specific clinical evaluation and additional-data plan. Do not assume clinical investigation is universally required or universally unnecessary.
Assess effects of the new site, method or process on sterility and device characteristics. Review validation, packaging, shelf life and biological safety as needed. Follow the relevant notified body's change and notification rules. The same service name does not establish coverage by earlier evidence.
The exact records for MDR Required Documents depend on the confirmed scope. Current, consistent and traceable information reduces avoidable revisions.
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