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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 is a significant risk factor in device classification. Most implantable devices are classified as Class III or IV due to the inherent 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

Long-term clinical evidence​

"The specific duration of clinical follow-up required depends on the device type and expected lifespan. For example, joint replacements typically require 5-10 year follow-up data, while cardiovascular implants may require longer observation periods. Manufacturers should consult Health Canada's device-specific guidance documents or request a Type A meeting to clarify clinical evidence requirements early in development. Participation in implant registries (such as provincial hip and knee registries) may be expected for certain device categories."