Health Canada, the country’s authority responsible for medical devices regulation, has published guidance describing the risk-based classification system to be applied for medical devices that are not in vitro diagnostic ones (non-IVDDs). The aspects related to the classification of in vitro diagnostic medical devices are outlined in the appropriate guidance issued by the authority as a separate document. The same applies to the classification rules for combination product
Regulatory Background
The present guidance is intended to provide medical device manufacturers and other parties involved with additional clarifications and recommendations related to the existing risk-based classification of medical devices adopted in Canada. The provisions of the document will also be considered by the Health Canada staff when performing the appropriate regulatory actions. At the same time, the authority reminds that the provisions of the guidance are not binding due to their legal nature. In the case of any discrepancies with the provisions of current legislation, the latter shall prevail.
Moreover, an interested party is allowed to apply an alternative approach, provided such an approach complies with the relevant regulatory requirements and has been approved by the authority in advance. Additionally, the authority reserves the right to request medical device manufacturers to provide additional information reasonably necessary to assess the aspects related to the safety and performance of the medical device subject to review. All requests should be duly justified and reasonable, and all the decisions based thereon should be documented.
The latest version of the guidance on classification for non-in vitro diagnostic devices was issued in mid-2015 and replaced the draft guidance issued earlier in 1998.
The risk-based approach to classification for medical devices addressed in the present guidance was introduced in accordance with the Medical Devices Regulations. The risk-based approach prescribes that the scope of evidence to be provided by the medical device manufacturer applying for marketing authorization should be determined depending on the risks associated with the use of the medical device in question. Current Canadian medical device classification includes four classes from I to IV, respectively.
The authority additionally emphasizes that existing classification is based mostly on hazards associated with a medical device and not on the probability of adverse events.
According to the document, existing medical device classification incorporates some principles and approaches initially introduced by the EU Council Directive 93/42/EEC. For instance, the approach for supporting documentation to be provided by the applicant is almost the same as prescribed by the aforementioned European regulation. Thus, in most cases, a medical device will be assigned to the same class under both Canadian and European medical device classification systems. Nevertheless, certain exclusions could still take place, so interested parties intending to place their products on the Canadian market should refer to the Canadian medical device classification rules, respectively.
Basics of Medical Device Classification
The medical device classification system used in Canada is based on the following factors:
- Degree of invasiveness,
- Duration of contact,
- Body system affected, and
- Local versus systemic effects.
The first factor deals with the period of time within which the device is intended to be used. Actually, there are two categories to be applied in this regard: long-term use (exceeding 30 days) or not (shorter than the period mentioned above). For the purpose of this provision, the period of continuous use refers to the period of time within which the device is being used without interruptions for the initial purpose determined by its manufacturer.
The class of a medical device under the Canadian medical device classification system should be determined mostly on the basis of the intended use of the medical device in question. Any and all documents accompanying the medical device (e.g., instructions for use or user manuals) should indicate the same class under the risk-based classification. The only exclusion for indication of the intended purpose of the device in its labeling applies if the intended use of the device is obvious; hence, the obligation to indicate the intended use in labeling could be waived.
It is the sole responsibility of the manufacturer to determine the class of the medical device in accordance with the Canadian medical device classification system on the basis of existing rules described in the present guidance. In certain cases, several rules could be applicable. In such situations, the manufacturer shall apply the rule which is related to the higher risk.
However, the authority also states that sometimes novel medical devices fall outside the scope of the current medical device classification system, so the existing classification rules cannot be applied for them. Sometimes, this happens due to specific medical device features, and sometimes it is due to unusual risks.
The authority additionally mentions that the determination it makes regarding the classification of a medical device subject to review should be final and replace the one made by the manufacturer, if different. At the same time, should the manufacturer disagree with the determination made by the authority, it may request a reconsideration of such a decision.
Key Concepts
To ensure legal clarity, the present guidance provides the definitions of the most important terms used in the context of classification of medical devices, including the following:
- Active therapeutic device stands for an active device that, whether used alone or in combination with another medical device, is intended to support, modify, replace or restore a biological function or structure for the purpose of treating or mitigating an illness or injury or a symptom of an illness or injury.
- Closed-loop system, when used in the context of a medical device, stands for a system that enables the device to sense, interpret and treat a medical condition without human intervention.
- Surgical or dental instrument stands for a reusable medical device that is intended for surgical or dental use, including cutting, drilling, sawing, scraping, clamping, hammering, puncturing, dilating, retracting, or clipping without connection to an active device.
Special Rules
The present Health Canada guidance also describes special rules that constitute exceptions to the general ones, namely:
- Medical devices intended for disinfection or sterilization are Class IV medical devices unless they are intended to disinfect medical devices only.
- Medical devices based on animal or human cells, or incorporating similar materials, are Class IV medical devices unless they are intended to contact intact skin only.
- Materials provided to healthcare professionals to be used as a basis for a medical device should be assigned to the same class under the existing classification system as a final medical device to be created.
In summary, the guidance document issued by Health Canada describes the most important aspects related to the country’s risk-based classification system. In particular, the document outlines the main classification rules and provides recommendations on how they should be applied.
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