Active Implantable Devices | MedTech Compliance Guide

EU requirements

Classification: Active implantable devices and their accessories are Class III under MDR Annex VIII Rule 8.
Conformity pathway: Class III requires Notified Body involvement through Annex IX or Annex X plus XI; self-declaration is not available.

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01Confirm Class III status under Annex VIII Rule 8.Source: MDR 2017/745 Annex VIII
02Plan and conduct a clinical investigation under Annex XIV and XV.
03Apply applicable ISO 14708 series requirements.
04Perform ISO 10993 biocompatibility testing.
05Engage a Notified Body under Annex IX or Annex X plus XI.
06Prepare an Implant Card, assign a UDI, and establish a PMCF plan.

Classification: Active implantables are almost universally Class III, generally under 21 CFR Part 870 or an equivalent device-specific part.
Conformity pathway: The expected route is PMA under 21 CFR Part 814.

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01Confirm Class III status and the applicable 21 CFR Part 870 or relevant product code.
02Plan and execute clinical investigations under an IDE (21 CFR Part 812).
03Compile a PMA application under 21 CFR 814.20.Source: 21 CFR Part 814
04Conduct ISO 10993 biocompatibility and IEC 60601-1 and ISO 14708 safety testing.
05Establish a DHF and QMSR-aligned quality system.Source: FDA QMSR
06Prepare for FDA PMA panel review and post-approval annual reporting.Source: FDA PMA overview