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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

Implant card requirements ​ High-risk implantables (cardiac pacemakers, artificial joints, vascular stents, spinal implants) must include an implant card for the patient containing: device name, model number, serial number, lot number, implantation date, and manufacturer contact information. The card facilitates future medical imaging, device identification in emergency situations, and post-market surveillance.