The practical questions below concern own-brand responsibility, Class I body involvement and clinical evidence. These decisions shape the device's actual MDR route. Compare the answers with intended purpose, design and technical documentation; classification and evidence cannot be established merely by the product's commercial name or a supplier's certificate.
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.
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.
TRTürkçe
ENEnglish
AZAzərbaycanca
UZO‘zbekcha
ARالعربية
FRFrançais
DEDeutsch
RUРусский