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Implantable Devices

Definition​

An implantable device is a device intended to be totally introduced into the human body, or to replace an epithelial surface or the surface of the eye, by surgical intervention, and intended to remain after the procedure.

Classification implications​

Implantability generally elevates a device's classification. Most implantable devices are Class III or IV due to the risks associated with:

  • Long-term tissue contact (biocompatibility concerns)
  • Surgical implantation procedure
  • Difficulty of removal if problems arise
  • Long-term device-body interactions

Biocompatibility​

Implantable devices must undergo a comprehensive biocompatibility evaluation per ISO 10993-1, including:

  • Cytotoxicity
  • Sensitisation
  • Genotoxicity / carcinogenicity (for long-term implants)
  • Chronic toxicity
  • Implantation assessment
  • Biodegradation (for absorbable implants)

MRI safety labelling​

Implantable devices must carry MRI safety information:

  • MR Safe — no known hazards in MRI environments
  • MR Conditional — safe under specified conditions
  • MR Unsafe — poses unacceptable risks in MRI environments

MRI safety must be determined by testing per applicable standards (e.g., ASTM F2052, ASTM F2503).

Long-term clinical evidence​

Long-term clinical data is typically required for implantable devices, as risks may not manifest until years after implantation. Health Canada may require:

  • Clinical follow-up data (e.g., 5-year or 10-year data for joint replacements)
  • Implant registry data
  • Post-market clinical follow-up plan

Implant card (for certain implants)​

Some implantable devices are subject to implant card requirements — a card given to the patient at the time of implantation containing device identification information. Health Canada follows IMDRF guidance on implant cards.

Legislative source: Medical Devices Regulations, SOR/98-282; ISO 10993 series