MDR classification follows intended purpose and the rules in Annex VIII, including invasiveness, duration and relevant active-device characteristics. Classes I, IIa, IIb and III determine different routes. Class I still needs technical documentation; sterile, measuring and reusable surgical instrument aspects can require notified-body involvement. A product name alone is not a classification rationale.
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.
Review effects on intended use, clinical decisions, performance and risks. An interface correction differs from adding a diagnostic function. Update verification, risk and clinical evidence where needed and make required notifications. A minor version-number change does not establish a minor regulatory effect.
The exact records for MDR Medical Device Class I, IIa, IIb and III Guide depend on the confirmed scope. Current, consistent and traceable information reduces avoidable revisions.
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