Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the investigation of reported medical device problems. The document is intended to assist medical device manufacturers and other parties involved in interpreting and applying the relevant regulatory requirements with regard to issues associated with the medical devices placed on the Canadian market.
The regulating authority emphasizes the non-binding legal nature of recommendations provided in the guidance and explicitly states that in the case of any discrepancies with the provisions of current legislation, the latter should prevail.
According to the applicable legislation, the manufacturer, importer and distributor of a medical device shall each establish and implement documented procedures that will enable the manufacturer, importer or distributor to carry out (a) an effective and timely investigation of the problems referred to in paragraph 57(1)(a). The appropriate procedures should be duly developed and implemented by the holders of Medical Device Establishment Licenses (MDELs). The present document describes how an investigation should be carried out by a responsible entity as prescribed by the applicable legislation.
Documenting the Procedure
As stated in the guidance, an investigation procedure to be developed by a medical device manufacturer (or other party involved in supplying medical devices) should describe the processes performed by such an entity. This description should be detailed enough to ensure consistency in their actual implementation. However, if some of the actions are to be performed by third parties, such actions could be simply mentioned in the procedure, provided that the main points related to cooperation with such third parties and timelines for these actions to take place are duly described. For instance, an importer of medical devices should have in place a procedure describing how it will receive and process the information related to the issue. Since the investigation itself should be carried out by the medical device manufacturer, it would be sufficient for an importer to outline the key points regarding its cooperation with the manufacturer in this regard.
Format of the Procedure
According to the present Health Canada guidance, there are no strict requirements regarding the format of the procedure to be adopted by the parties involved in operations with medical devices in the context of problem investigation. At the same time, there are certain key elements to be included in any standard operating procedure.
Implementing the Procedure
When determining whether the policy on problem investigation has been duly implemented, the following aspects should be taken into consideration:
- All related activities should be carried out and documented strictly in accordance with the procedures;
- The key persons involved in the decision-making process in the context of medical device problem investigation should have the necessary qualification and pass the appropriate training;
- The reasonable measures are taken in order to ensure the latest version of the policy is used (to be achieved by means of version control);
- All aspects related to cooperation with third parties involved in processes described in the procedure are well-established in order to ensure the effectiveness of such cooperation (the authority additionally emphasizes the importance of ensuring that the actions to be taken by third parties are actually performed);
- The relationships between the parties involved are duly regulated by the appropriate agreements;
- The procedure requiring the involvement of a third party is approved by such a third party.
Investigation Procedure: Specific Aspects
The document further describes in detail certain specific aspects to be considered in the context of medical device problem investigation. It is stated that the procedure to be developed and implemented by the responsible party should cover the most important matters, including the following:
- Definitions and use of key terms, including risk management terms;
- Scope of procedure;
- Roles and responsibilities;
- Risk-based time constraints;
First, the procedure should provide the definitions of the most important terms and concepts used in the context of medical device problem investigation in order to avoid confusion due to misinterpretation of terms. The authority provides an example when a carefully worded definition for “reported problem” or “complaint” may establish the scope of the procedure for regulatory purposes. For instance, one can use the terms provided in the applicable standard CAN/CSA-ISO 14971 Medical Devices – Application of Risk Management to Medical Devices.
According to the applicable regulations, the scope of documented procedures on medical device problem investigation should cover the aspects related to the safety and performance of products. However, the responsible entity is entitled to expand the scope of the procedure at its sole discretion. At the same time, it is important to ensure the proper balance, as the expansion of the scope means that the same approach would be applied to the issues associated with the low risk, while the application of the same measures as in case of severe issues in such situations could be unreasonable. Alternatively, the documented procedure could be based on dividing the medical device problems into several types and applying respective measures corresponding to the risks associated with the particular issue.
It is also stated that the safety and performance issues to be covered by the scope of the documented procedure should include:
- Problems, involving the device itself, its packaging and labelling, once it is released for sale by the manufacturer, or authorized for sale for investigations testing;
- Compliance with regulatory requirements, among the device “performance characteristics”;
- “Consumer complaints,” reported by patients or users of the device; and
- Problems reported from any source.
The authority also mentions that the term “reported problem” itself is not defined in the current legislation. The same applies to the term “investigation,” which is also not defined in existing regulations. As explained in the present guidance, the scope of the investigation should be interpreted as covering all actions taken by the party responsible for a medical device from the moment it becomes aware of the issue associated with the safety and effectiveness of the product until its closure.
The documented procedure should also specify the particular individual to be responsible for ensuring that the actions described in the procedure are duly followed. Additionally, the procedure could contain indications of the particular individuals or groups responsible for specific processes. Should the procedure prescribe that such processes should be carried out by an independent third party, there should be an indication of the representative of a third party responsible for the matter.
In summary, the present guidance issued by Health Canada outlines the most important aspects to be considered by the entities responsible for medical devices when developing and implementing the documented procedures for medical device problem investigation. The document outlines the scope of key elements to be covered by the documented procedures and describes the principles of cooperation with third parties.
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