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Systems & Procedure Packs

Definition​

A system is a combination of two or more finished medical devices and/or other products (including non-device components) that are assembled and packaged together to achieve a specific intended use as an integrated unit. A procedure pack is a pre-assembled combination of finished products (medical devices, instruments, consumables, and other items) intended for use together in a specific medical or surgical procedure.

Examples​

  • Surgical trays containing instruments, drapes, and consumables pre-assembled for a specific procedure
  • Infusion sets combined with a fluid bag and related accessories
  • Wound care packs containing dressings, antiseptics, and applicators
  • Diagnostic kits combining an IVD reagent, calibrators, and controls

Regulatory requirements​

Where all components of a system or procedure pack already hold individual Device Licences (or are Class I devices), the assembler of the system/pack:

  • Is not required to obtain a new Device Licence for the combination
  • Must not modify components in a way that affects their original performance or safety
  • Must label the system/pack in compliance with MDR labelling requirements
  • Must hold an MDEL (the regulatory status—distributor or manufacturer—depends on the activities performed; if components are only assembled without modification, distributor status may apply; if sterilization or other manufacturing activities are performed, manufacturer status applies)

If assembling a system requires modifying a component (changing its intended use, modifying its design), a new Device Licence for the modified component or the system may be required.

Sterilisation of systems/packs​

If a system or procedure pack is assembled and then sterilised by the assembler, the assembler takes on the responsibilities of a manufacturer with respect to the sterilisation process, including:

  • Sterilisation validation
  • Packaging validation
  • Labelling for sterilised products

Legislative source: Medical Devices Regulations, SOR/98-282; Health Canada guidance on systems and procedure packs

Expand 'Regulatory requirements' section to add: "Device Licence Requirements for Systems and Procedure Packs\n\nA system or procedure pack does NOT require a separate Device Licence if:\n• All component medical devices already hold individual Device Licences or are Class I devices without licence requirements\n• The assembler does not modify any component's design, materials, or intended use\n• The system/pack is labeled according to MDR requirements\n\nA separate Device Licence IS required if:\n• Any component is unlicensed or is being modified by the assembler\n• The system's assembled configuration creates a new intended use not covered by existing component licences\n• The assembler claims a new clinical indication not supported by component licences\nWhen in doubt, applicants should submit a Type A meeting request to Health Canada for classification confirmation."