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Under what circumstances can a medical app be classified as Class I under MDR?

Anonymous · Published December 15, 2025 · 1 comment
Is it possible for a medical app to be classified as Class I under MDR, and what are the criteria? For example, if an app offers therapy guidance without personalizing treatment based on individual medical conditions, but adapts to user progress, can it qualify as Class I? Any references to guidance documents or certified examples would be appreciated.

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Anonymous 6 months ago
Looking for clarification and examples of Class I MDR app classifications.
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6 Answers

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
You need to conform to MDR rules, so post-marketing surveillance and having a PRRC are required. For companies in Germany, the MPDG (which replaced the MPG by end of May) also refers to the PRRC as necessary. Some notified bodies already require proof of PRRC qualification, even for MDD devices submitted close to the May deadline. EUDAMED registration of actors, including the PRRC, was required for some companies as well. In summary, you should have your PRRC in place at the latest by the time you submit MDR technical documentation, and possibly earlier depending on your national competent authority.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
I haven't used Intellect or ins2outs personally, but we use Matrix Requirements. It's focused on software development and is very proactive, covering much more than just QMS (like requirements management). The only thing missing is ticket management. Other platforms people mention are Greenlight Guru (more FDA-oriented, pricey, and clinical evaluation is missing), IMSXpress (less expensive, older UI), Polarion (feature-rich but complex and self-hosted), Google Drive, GitLab, Jira, and Confluence (all require customization for compliance, especially around versioning and signing).

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
We don't write down root causes for all matters reported to us, only for those that have a clinical safety, performance, or security impact. We register all market feedback, but only escalate as complaints those that meet our criteria. Our complaint handling process is compliant with ISO 13485 (8.2.2), and our PMS plan/report includes overall analysis like classification, trend analysis, and significant changes. Not every complaint needs a root cause analysis or CAPA—focus your resources where risk justifies it. This approach has been accepted by our notified body.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
MDCG 2020-03 clarifies that changes not impacting the design or intended purpose, such as relocation or address change, are considered non-significant under MDR Article 120(3). For Class I devices, this usually means no notified body involvement; update your Declaration of Conformity and inform your competent authority as required. For higher classes, notified bodies may see it differently and require a change to your CE certificate and registration (like DIMDI). In practice, some notified bodies have performed address verification audits. For software-only companies, the process is usually straightforward, but always document your impact assessment and update official documents as necessary.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
I have applied clause 4.4 once for software developed before IEC 62304:2015. You need to establish and execute a gap closure plan (determine an action for each identified gap in your analysis). The legacy parts can be registered as MDD class I devices before the MDR date of application. Note that you still need to be ready to demonstrate your approach during inspections. The clause is interpreted strictly: it applies to software created prior to the current version of the standard. We'll know more after the next inspection!

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
It is possible but rare for a medical app to be classified as Class I under MDR. The key is that the app must not perform any diagnosis or provide therapy decisions based on individualized medical data. For example, apps that only offer general guidance or adapt based on user progress (such as simple exercise levels) can potentially be Class I. As an example, the Johner Institut released an app for vertigo that's certified as Class I MDR. However, many experts say it's nearly impossible under MDR unless the app is strictly non-personalized and doesn't impact clinical management. Always check the latest MDCG guidance and compare with notified body expectations.

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