Medical devices contained in electronic health record (EHR) products: Notice to industry

This notice is for manufacturers of EHR software products and EHR-based medical devices. Through this notice, Health Canada wants to remind manufacturers of their regulatory obligations for EHR-based medical devices in Canada. Our goal is to reduce potential risks to patients.

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An electronic health record (EHR) is a software product intended primarily to replace a patient’s paper medical file. It also enables other functions.

Health care facilities can use an EHR to electronically receive, collect, store, manage, display, output and distribute a patient’s medical information within their own facility or with other facilities.

Health care providers can use an EHR to review and update a patient’s medical records or place orders (for example, orders for medications, procedures or tests).

EHR software products intended for the above purposes do not meet the definition of a medical device under the Food and Drugs Act (act) and Medical Devices Regulations (regulations).

Components, accessories or modules within an EHR that are intended for use to diagnose, treat, mitigate or prevent a disease, disorder or abnormal physical state (or their symptoms) are considered a medical device. Thus, they are subject to regulatory oversight under the regulations.

Health Canada has communicated this information in the past. Examples include:


Health Canada has learned of 2 issues relating to EHR-based medical devices that may pose a risk to patient safety:

  1. Unauthorized EHR-based medical devices may be available on the Canadian market and in clinical use without the appropriate regulatory oversight.
  2. Information provided by EHR manufacturers to health care facilities, health care providers and users about introducing or modifying medical devices within an EHR system may be inadequate.

Notifications to industry

Components, accessories or modules within an EHR that have a medical purpose (for example, to assist or replace a diagnostic or treatment decision) are medical devices. Thus, they are subject to regulatory oversight under the regulations.

You may not sell or advertise for sale an EHR-based medical device in Canada without the necessary authorization. Authorization could be a medical device licence and/or establishment licence, as appropriate. This prohibition also applies to software updates that introduce a medical device function.

As a manufacturer, you must inform health care facilities, health care providers and users of any new or modified medical devices within the EHR. You must provide the necessary information required for use (such as the intended use, instructions for use, performance specifications and risks). This requirement is specified in sections 10 to 20 (on safety and effectiveness) and sections 21 to 23 (on labelling) of the regulations.

Health Canada can take regulatory enforcement actions when we identify instances of non-compliance. The actions we take will be in accordance with the Compliance and enforcement policy for health products (POL-0001).

Guidance for industry

To help you understand whether an EHR component, accessory or module is a medical device, please consult the following guidance document:

As well as this particular guidance document, you may consult the following guidance documents to help you determine the appropriate risk classification (from Class I to IV) of a medical device:

Visit the Medical Devices Active Licence Listing (MDALL) web page to see if a manufacturer has an active Class II, III or IV medical device licence for a given product.

Before submitting a new or amendment application for a Class II, III or IV medical device licence, you should consult the relevant guidance relating to medical devices.

Contact us

Email your questions or comments about this notice to the Medical Devices Directorate at

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