Non-Active Implantable Devices | MedTech Compliance Guide

EU requirements

Classification: Under MDR Annex VIII Rule 8, non-active implants are Class IIb by default. They escalate to Class III for heart, central circulatory system, or central nervous system contact; biological effect or substantial absorption; chemical change; drug administration; and specified breast, mesh, joint, and spinal implants.
Conformity pathway: Class IIb generally uses Annex IX or Annex X plus XI; the Class III subset follows the corresponding higher-risk route. Sampling exemptions for well-established technologies under Commission Delegated Regulation (EU) 2026/1359 require current-scope confirmation.

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01Classify under Annex VIII Rule 8 and check every explicit Class III trigger.Source: MDR 2017/745 Annex VIII
02Check eligibility for Notified Body sampling exemptions under (EU) 2026/1359.
03Conduct ISO 10993 biocompatibility testing.
04Compile a Clinical Evaluation Report.
05Prepare an Implant Card and PMCF plan, and assign a UDI.

Classification: Classification is product-code-specific: many long-term non-active implants are Class II, while higher-risk implants may be Class III. Verify the exact regulation and product code for the specific implant subtype.
Conformity pathway: Many Class II implants use 510(k); higher-risk devices such as some spinal and breast implants typically use PMA.

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01Identify the classification regulation and product code under 21 CFR Part 878, Part 888, or another applicable part.
02Determine whether a 510(k) or PMA pathway applies.
03Conduct biocompatibility and mechanical or fatigue testing.
04Establish a DHF.Source: FDA QMSR
05Prepare a 510(k) equivalence comparison or PMA application.