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Implantable Devices

Most implantables are Grade III or IV. Additional requirements include:

  • Biocompatibility — ISO 10993 with focus on long-term implantation effects
  • Sterilisation validation — all implantables supplied sterile
  • Robust clinical data — mandatory (pivotal trial expected for Grade IV)
  • Implant card — for certain high-risk implantables (cardiac, joint replacement)
  • UDI-K at unit level — production identifier (PI) must be recorded in patient hospital record