Define intended purpose and the legal manufacturer, justify classification and select the MDR conformity route. Map risk, technical, clinical and post-market evidence and implement the required quality controls. Arrange notified-body assessment where needed, resolve findings and prepare the EU declaration and market-release records. Existing quality-system certification does not bypass device-specific work.
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.
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.
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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