MDCG 2019-11: Guideline for qualifying and classifying software under MDR & IVDR

With the implementation of the European Medical Devices Regulation (MDR, 2017/745) and the In Vitro Diagnostics Regulation (IVDR, 2017/746), manufacturers, developers and operators of medical software are facing stricter regulatory requirements. With the 2019-11 guideline, the Medical Device Coordination Group (MDCG) has published a binding Europe-wide document that explains in practice when and how Software as a medical device (Medical Device Software, MDSW) is to be classified.

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1. Qualification: When is software considered a medical device?

The “intended purpose” of the software is decisive:

• MDSW Is there when a software
  • to diagnose, monitor, treat, alleviate or prevent illness,
  • is used to identify, monitor, treat, alleviate or compensate for injuries or disabilities,
  • or is used to examine, replace or change the anatomy or a physiological process.
• Software that exclusively pursues administrative, lifestyle or wellness purposes applies not as MDSW under MDR/IVDR.

What is new with the 2025 revision is Clarification on software that only processes health information: Only if this directly serves a medical purpose is the software subject to MDR/IVDR.

2nd classification: Which risk class does the software fall into?

The classification is essentially based on Annex VIII of MDR (in particular Rule 11), where the type of software function and the consequences of a malfunction are decisive.

• Class I (low risk): For example, management software without clinical decision.
• class IIa/IIb: Decisive for diagnosis, treatment decision, or when it permanently monitors the patient's condition.
• Class III (highest risk): Treatment decisions for critical conditions or life-threatening illnesses.

Particularly important: MDR/IVDR requires an individual analysis of each individual software function (modular structure). Manufacturers must therefore separately evaluate and document an app with administrative and diagnostic functions, for example.

3. Practical examples & clarifications

The guide contains numerous case studies:

• Diagnostic apps: AI algorithms for evaluating X-ray images = always MDSW.
• Therapy control: Programs that calculate insulin doses in real time fall under class IIb-III.
• Informative apps: Software that only provides information on health topics (without individual reference) is not MDSW.
• AI/machine learning modules: As long as they are clinically intended, they must be treated as MDSW.

4. Special innovations and challenges

• Advanced examples of multinational/modular software products and those with multiple purposes.
• Detailed information on the distinction between MDSW and IVD software: If the program is intended for laboratory diagnostics, for example, the IVDR is used.
• Taking new technologies into account such as cloud, mobile health, big data, and interoperability with electronic health records (EHR).

5. Implications for manufacturers and developers

• For each software function, a clear purpose, risk analysis, and an independent classification must be carried out (documentation requirement!).
• The involvement of development partners, clinical experts and notified bodies is recommended to avoid regulatory pitfalls at an early stage.
• Even for existing apps/software products, developers must constantly check whether adjustments to the regulations change the qualification or classification.

6. Significance for the digital health market

With MDCG 2019-11, there is comparable, practical regulatory guidance for digital medical technology across Europe for the first time. This increases legal certainty and creates equal opportunities in the EU internal market.

For start-ups, health-tech companies and innovation projects in particular, it is essential to know these requirements and incorporate them right from the concept phase, as approval, marketing and subsequent adjustments of software products depend directly on them.

More resources and links

The full document “MDCG 2019-11 rev.1” is freely available on the European Commission's website. To deepen your knowledge, it is also recommended:

• Rule 11 (“Rule 11”) in the original MDR text
• Latest MDCG guidance documents and updates
• National guidelines and publications on digital health & medical device software

Conclusion:

The MDCG 2019-11 guideline is mandatory reading for anyone who develops, distributes or uses medical software in Europe. Careful implementation saves time, costs — and protects patient safety and competitive opportunities in the fast-growing market for digital health!

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