The new article describes in detail the aspects related to the submission of clinical evidence in the context of applications for marketing approval.
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Health Canada, a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to clinical evidence requirements for medical devices. The document provides an overview of the existing regulatory framework, as well as additional recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance with the respective regulatory requirements. It is also important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Submitting Clinical Evidence: Key Points
Under the general rule, any and all medical devices intended to be marketed and used in Canada should comply with the applicable regulatory requirements in terms of safety and effectiveness. The authority will review the application submitted by an interested party in order to assess whether the product in question actually meets the said requirements.
The application to be submitted by an interested party should include, inter alia, sufficient clinical evidence demonstrating compliance with the safety- and performance-related requirements the product is subject to. As further explained by the authority, clinical evidence submitted by the applicant should demonstrate:
- The device is safe and effective when used as per the statement on indications for use, and
- How the device affects diverse subpopulations, such as women and gender-diverse people, racialized minorities, pediatric and other populations (when applicable).
Moreover, the authority expects the applicants to provide information with respect to:
- The risks and benefits associated with using the device, and
- The uncertainty associated with how accurately they can define the risks and the benefits of the device.
According to the guidance, a medical device license required in order for the device to be placed on the country’s market will be issued under the condition that the information provided by the applicant (including clinical evidence as described herein) demonstrates that:
- The device meets the requirements, and
- The benefits of the device outweigh the identified risks, and
- The uncertainties relating to the benefits or adverse effects associated with the device are not significant.
It is also important to mention that the authority is entitled to implement additional requirements in order to ensure continuous compliance with the applicable requirements throughout the whole period of the expected lifetime of the product. The authority also reserves the right to request assertional information to be provided after placing the medical device on the market, demonstrating continuous compliance with the applicable safety- and performance-related requirements set for under the existing legislation including, but not limited to, the Medical Devices Regulations (the Regulations).
Clinical Evidence to be Submitted
The document further outlines the scope of clinical evidence the authority expects the interested parties to submit when applying for marketing approval. In accordance with the existing regulatory framework, the scope of evidence required and the regulatory burden associated thereto depends on the class of a medical device in question under the applicable risk-based medical device classification system. In particular, the following rules apply:
- Manufacturers of Class II medical devices must submit at attestation that they have objective evidence to establish that the device is safe and effective (paragraph 32(2)(c) of the Regulations).
- Manufacturers of Class III medical devices must submit a summary of all studies on which they rely to ensure that the device is safe and effective, and the conclusions that they have drawn from those studies (paragraph 32(3)(f) of the Regulations).
- Manufacturers of Class IV medical devices must submit clinical data on which they rely to ensure that the device is safe and effective (paragraph 32(4)(i) to (n) of the Regulations.
The authority also mentions that the appropriate evidence should be submitted with respect to both new applications and the ones amended after the initial submission. Furthermore, since additional information could be requested in the course of application review, medical device manufacturers should have all the information necessary to be able to provide it upon request.
When Clinical Evidence is Required
The document further describes the situations when clinical evidence should be submitted with respect to the applications for marketing approval. Under the general rule, any and all medical devices should have sufficient evidence demonstrating compliance with the respective safety- and performance-related requirements. At the same time, in certain cases, device-specific investigations could be required in order to address specific aspects associated with the device in question. Thus, the authority intends to assess all the applications or requests for changes thereto based on the information and documentation provided by the applicant, and in the context of the indication for use provided by the manufacturer.
According to the guidance, device-specific clinical evidence may be required for the following:
- Novel technologies;
- Less established technologies;
- New safety or effectiveness issues with established technologies;
- Design modifications to established technologies;
- New indication for use;
- New target population;
- New intended user;
- When the impact of the device on the patient, or the impact of the proposed device change on the patient, is:
- Not fully characterized by the non-clinical data available,
- Irreversible,
- Variable,
- Invasive as defined in the Regulations,
- Unknown.
In summary, the present guidance issued by Health Canada describes in detail the approach to be applied when determining the scope of clinical evidence to be submitted to substantiate the claims made by the medical device manufacturers, and also when determining whether clinical evidence should be submitted in a specific case. With respect to the above, the document outlines the criteria to be used and key aspects to be taken into consideration.
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