The Medical Device Coordination Group (MDCG) has released Revision 1 of MDCG 2019-11, a critical guidance document addressing the qualification and classification of software under the Medical Device Regulation (MDR, EU 2017/745) and the In Vitro Diagnostic Regulation (IVDR, EU 2017/746).
This revision introduces expanded guidance for Medical Device Software (MDSW) developers, regulatory affairs professionals, and manufacturers navigating the complexities of EU software compliance.
Purpose of the Guidance
The document provides:
- Criteria to determine whether software qualifies as a medical device or in vitro diagnostic device.
- Rules for risk classification based on intended purpose and impact on patient care.
- Guidance on modular software, software changes, and conformity assessment pathways.
- Clarifications on Annex XVI devices and interoperability with Electronic Health Record (EHR) systems, particularly under the European Health Data Space (EHDS) Regulation.
Major Updates in Revision 1 of MDCG 2019-11
Some of the major updates included in MDCG 2019-11 include:
1. Intended Purpose and Software Qualification
The guidance reinforces that determining whether software qualifies as a medical device begins with how the manufacturer defines its intended use.
- Intended purpose must be clearly documented, supported by evidence, and traceable in labeling and technical documentation.
- Software that supports individual clinical decisions (e.g., diagnosis, therapy planning, or monitoring) may qualify as MDSW.
- Software performing purely administrative or general wellness tasks is excluded unless it affects a medical device’s function or patient outcome.
2. Modular Software Architecture
As modular architectures become common in software design, Revision 1 introduces specific recommendations for handling systems composed of multiple functional units.
- Each software module must be assessed for its medical purpose and regulatory relevance.
- Medical and non-medical modules must be delineated in the technical documentation.
- Non-medical modules that impact the safety or performance of the MDSW must still be evaluated.
- Modular approaches must not be used to bypass classification rules or dilute regulatory responsibilities.
3. Updated Rule 11 Clarification
The revision refines Rule 11 of MDR Annex VIII to enhance risk-based classification, particularly for software that supports clinical decision-making.
- Rule 11a applies to software that provides information used for diagnosis or therapeutic decisions.
- Rule 11b covers software that monitors physiological processes (e.g., vital signs).
- Rule 11c includes all other MDSW not covered above, typically Class I.
- Risk classification depends not only on software functionality but also on the severity of the potential clinical impact if the software fails.
4. In Vitro Diagnostic Software (IVD-SW) Provisions
For software that qualifies under Regulation (EU) 2017/746 (IVDR), similar rules apply, but with an emphasis on analytical and clinical performance.
- IVD-related software is classified using the IVDR Annex VIII classification rules (especially Rules 1 to 5).
- Software that drives or influences IVD instruments must be evaluated together with the instrument.
- Applications that interpret laboratory results or support genetic testing decisions may fall under Class C or D, depending on risk.
SEE ALSO: Quality Risk Management (QRM)
5. Expanded Classification Examples
Annex IV introduces new examples, including:
- MDSW integrated with wearable tech or apps for mental health.
- Software providing therapy via VR (e.g., PTSD treatment).
- Closed-loop insulin delivery systems.
These examples illustrate both standalone MDSW and software influencing device operation.
6. Interplay with EHDS and EHR Systems
With the development of the European Health Data Space (EHDS), software interoperability is a key focus of the revision.
- MDSW claiming interoperability with EHR systems must comply with both MDR and applicable EHDS requirements.
- The software’s interaction with health records must not compromise data integrity, clinical decision-making, or cybersecurity.
- Relevant use cases are discussed in Annex I (c.1) of the guidance.
Conformity Assessment Pathways
The document outlines how classification impacts the choice of conformity assessment route and the involvement of a Notified Body.
- Class I MDSW may follow a self-declared conformity route.
- A Notified Body must assess Class IIa, IIb, and III software under the appropriate conformity assessment procedure.
- For modular MDSW, assessment must consider interactions and dependencies across modules.
- Complete technical documentation, including clinical evaluation and performance data, is required for all classifications.
Key Takeaways for Industry
The updated guidance provides clear direction for stakeholders involved in developing or regulating medical device software. Here’s what organizations should prioritize:
- Define and document a precise intended purpose for every software product.
- Assess modular systems as a whole and in their components, and evaluate their respective roles and combined effects.
- Apply Rule 11 classification carefully, especially for software influencing clinical outcomes.
- Ensure that lifecycle changes are supported by continuous performance evaluation and version control.
- Align with broader digital health regulations, including EHDS and the upcoming AI Act, when applicable.
Download the full MDCG 2019-11 Rev.1 – June 2025 document here: Download PDF – ec.europa.eu
