In an August 2018 article entitled “Recent Developments in Regulation of Software as a Medical Device“, our friends Andrea Berenbaum and Noel Courage from Emergence Partner, boutique IP law firm Bereskin & Parr, write: “The digital health technology sector has undergone rapid expansion in recent years, and its growth is forecasted to continue”.
“One noteworthy class of technology in this sector is software as a medical device (SaMD),” Berenbaum and Courage point out.
SaMD has been defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
However, it is not always straightforward to distinguish between SaMD and other software such as medically-related non-SaMD.
As new innovations emerge and the field continues to evolve, some medical device regulators are working to adapt their policies and processes to uphold safety and efficacy, while also better aligning with the rapid design, development and modification cycle associated with SaMD. There is also a need for clarity as to what software fits within the definition of SaMD.
This article provides an overview of a few of the recent developments in this regard, with a focus on Health Canada, the Canadian regulator for medical devices.
Berenbaum and Courage write that “Health Canada announced earlier this year that it is establishing a new Digital Health Review Division ‘to allow for a more targeted pre-market review of digital health technologies, to adapt to rapidly changing technologies in digital health, and to respond to fast innovation cycles’. SaMD is considered a ‘key area of focus’ under this new initiative.”
“Companies making SaMD should keep on top of regulatory developments because the clear trend appears to be to try to accelerate the regulatory path to approval,” the authors conclude.
About Bereskin & Parr
Bereskin & Parr LLP is a leading Canadian full service intellectual property law firm serving clients across all industries around the world. Founded in 1965, the firm has grown to be one of the largest IP firms in Canada with offices located in major economic and technology centres. Bereskin & Parr is made up of more than 70 lawyers and patent and trademark agents, many of whom are recognized as leading practitioners in their specialized fields. The firm has established a depth of legal talent and systems to service clients in every aspect of patent, trademark and copyright law and IP litigation. The firm and its award-winning professionals are consistently ranked as the benchmark for IP law in Canada.