The article provides an overview of the regulatory requirement related to clinical evidence for medical devices.
Table of Contents
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to clinical evidence requirements for medical devices. The document is intended to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be followed by Class II, III, and IV medical device manufacturers, their representatives, and other parties involved to ensure compliance thereto. In particular, the guidance describes:
- When clinical data/evidence is required,
- The common methods to generate clinical data,
- How to compare devices appropriately.
The document describes the approach to be applied when determining whether clinical data/evidence is needed to support an application for marketing approval, the scope of clinical evidence needed based on the product in question and its specific features, the aspects related to the use of clinical data related to similar (comparable) products, the approaches to be applied when collecting clinical data, the scope of factors to be taken into consideration (e.g., sex or ethnicity), as well as the cases when the authority would expect clinical data to be provided within the scope of post-market obligations.
Recommendations provided in the guidance are based on the provisions of the Medical Devices Regulations (Regulations). As explained by the authority, the latter employs a risk-based approach when determining the regulatory requirements and the level of regulatory scrutiny to be applied. According to this approach, the evidence needed depends on the risks associated with the product in question. For this purpose, each medical device should be assigned to one of the risk categories from I to IV.
The information outlined in the guidance should be provided by medical device manufacturers to demonstrate that their products comply with the applicable safety- and performance-related requirements as set forth under the Regulations.
With respect to the legal nature of the guidance, the authority explains that recommendations provided therein are non-binding, so an alternative approach could be applied, provided such an approach is justified and discussed with the authority in advance to ensure compliance with any applicable requirements set forth under the existing regulatory framework. Furthermore, the authority reserves the right to request additional information or introduce additional requirements, should it be reasonably necessary to ensure the safety and effectiveness of medical devices allowed to be marketed and used in Canada.
Under the general rule, any and all medical devices intended to be marketed and used in Canada should be safe and effective when used for their intended purpose. As explained by the authority, the document describes, inter alia, the key principles to be followed with respect to clinical evidence used to support initial applications for marketing approval, as well as the one used in other stages of the product’s lifecycle. It is also important to mention that the aspects related to in vitro diagnostic medical devices fall outside the scope of the present guidance. Furthermore, device-specific guidance documents should be taken into consideration when available.
Terms and Definitions
First of all, the document provides definitions for the most important terms and concepts used in the context of clinical evidence for medical devices including, inter alia, the following ones:
- Clinical data – safety, clinical performance, and/or effectiveness information that is generated from the clinical use of a medical device;
- Clinical evidence – clinical data and its evaluation pertaining to a medical device;
- Clinical evaluation – assessment and analysis of clinical data to verify the safety, clinical performance, and/or effectiveness of a medical device when used as intended by the manufacturer;
- Clinical investigation – a systematic investigation (or clinical study) in human subjects undertaken to assess the safety and/or effectiveness of a medical device;
- Intended use/intended purpose – the objective intent regarding the use of a product, process, or service as reflected in the specifications, instructions, and information provided by the manufacturer.
Apart from the ones listed hereabove, the document also provides definitions of such terms as “clinical investigation plan”, “comparator device”, “established technology”, “indications for use”, “manufacturer”, “real world data (RWD)”, “real world evidence (RWE)”, “sex and gender-based analysis plan (SGBA+).
Clinical Data: Key Points
The document further highlights the most important aspects related to the collection and evaluation of clinical data for medical devices. According to the guidance, sources of such data include device-specific clinical investigations, published clinical literature, and post-market surveillance data.
In order to assist medical device manufacturers, study sponsors, and other parties involved, the authority also provides a non-exhaustive list of the factors to be taken into consideration when assessing the need for clinical data. According to the guidance, these factors include, inter alia, the following ones:
- Post-market data related to the performance of a comparable medical device,
- Specifics of the condition the device is intended to be used for and its seriousness,
- Risks associated with the device,
- The level of uncertainty with respect to the risks and benefits,
- Novelty of the technology used and information available with respect to it,
- Duration of use,
- The limitations of benefit with respect to the specific target population.
As explained by Health Canada, an application may be subject to an increased need for device-specific clinical data if there is a lack of safety and effectiveness evidence for:
- An emerging device technology, or
- A complex device designed to be implanted for a long time.
It is also important to mention that in case the data collection is in process, its results could be submitted at a later stage (after the license is issued) provided that the safety and effectiveness have been duly demonstrated.
In summary, the present guidance document issued by Health Canada provides an overview of the county’s current regulatory framework for clinical evidence. The document highlights the main principles and outlines the key factors to be considered by the parties involved.
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