The following policy statement was approved by the ITAC Health Board on September 7, 2010.
Canada’s health ICT companies are committed to meeting the highest standards for patient safety in their products and services. For this reason, ITAC Health supports the application of Health Canada's Medical Devices Regulations (MDR) as they apply to patient management software defined in Health Canada's Notice dated May 21, 2010. This regulation is appropriate for patient management software products that manipulate and interpret clinical data, which require a high standard of quality.
ITAC Health believes the MDR to be an important vehicle to "raise the bar" in terms of software product quality, safety and effectiveness. It is national in scope, is based on recognized international standards, and is overseen by a legitimate authority with its basis in law. ITAC Health sees Medical Device Licensing as an important first step towards the end-to-end adoption and application of existing and emerging national and international standards for all components of the Canadian health information infrastructure. It is also a foundational element in a national strategy for conformance, certification and licensing that addresses the needs of all stakeholders.
We note that the requirements of the MDR include ISO quality management certification, which addresses the product development process, instructions for use, delivery procedures, training procedures, and support procedures. The MDR also includes the safety and effectiveness requirements in sections 10 to 20 of the regulations, labeling requirements, and requires that manufacturers and distributers have processes in place for complaint handling, problem reporting and recalls.
Member companies who manufacture and sell software products which they market as having the capacity to guide clinical behaviour, highlight clinical risks to users, or are otherwise relied-upon by health professionals to be accurate in their representation of clinical data, are complying with the MDR. Many vendors have for many years obtained the necessary licenses for their products consistent with Health Canada's MDR and the regulatory authorities in other countries. Other vendors are currently engaged in the process of obtaining ISO 13485 Certification and MDR Licensing and will be compliant by Health Canada’s deadline of September 1, 2011.
We acknowledge that a transition to such a regulated environment can be a complex and expensive endeavour. We believe Health Canada’s concession to extend the deadline for compliance to September 1, 2011 is supportive of private industry’s capacity to conform. We also acknowledge that budgeting and planning processes for government and other public agencies introduce a further level of complexity possibly warranting a further extension of time. This would involve giving additional time to those public agencies that develop and distribute software to adjust their internal processes and procedures for MDR compliance, and for those public agencies that need to maintain and support health-critical legacy software systems while they migrate to licensed software. ITAC Health would support changes to the Notice to facilitate such a transition provided that patient safety was not compromised in doing so and that such extension is not exploited to avoid the use of private industry solutions, or to circumvent a private company’s obligation to conform.
We believe that compliance with the MDR is in the best interests of vendors, who stand to gain from increased health care provider and consumer confidence in the safety and effectiveness of their products, and of health care providers and consumers who will have evidence that products have been developed under conditions that promote safety and effectiveness.