Technical Documentation 1 answer

Should IT administrators be included as user roles in MDR technical documentation for SaMD?

Anonymous · Published March 01, 2026 · 2 comments
During our recent MDR technical documentation review, the notified body requested that we include service personnel (administrators) as user roles in our product description. Currently, we only list patients and professional users (doctors). For our SaaS solution, IT administrators are typically our own engineers. Is it standard practice to include IT administrators as user roles in the technical documentation for software as a medical device (SaMD), or should user roles be limited to those involved in clinical use? Any advice or references are appreciated.

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Anonymous 4 months ago
For service personnel as administrators/assistants, it makes sense if they are part of the intended purpose. Otherwise, including IT admins seems more relevant for traditional medical devices than SaMD.
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Anonymous 4 months ago
Do these users fulfill an essential part in the process or only provide support? Would you need to create a separate IFU for them?
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1 Answer

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
MDR Annex I, section 23.2(j) specifies that the label must include the "date of manufacture." Unlike the previous MDD, which allowed just the year, MDR expects a more precise date. While some companies use YYYY-MM as a minimum, there isn't a strict requirement in the MDR or MDCG guidance for the exact format (e.g., full date vs. year-month). However, providing only the year may not meet the MDR expectation, and your notified body may require at least year and month for clarity and traceability. If your notified body is asking for more detail, it's likely in response to this part of the regulation.

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