The European Commission has published Revision 1 of the MDCG Guideline 2019-11 and introduced important clarifications for medical device software under the MDR. The most important new features include:
- Clarification of the scope: Expanded definitions and delimitations for medical device software (MDSW)
- Emphasis on precise formulation of the intended purpose: A clear and unambiguous intended purpose is crucial for correct classification and avoiding compliance issues.
- Clarification of Rule 11: New guidance specifically for disease prevention software
- Expanded examples: New software use cases and clarifications regarding Annex XVI devices (devices without a medical purpose).
- Detailed guidance on the assessment of modules: Explanations on how to consider individual software functions or components in the classification process.
- Reference to the European Health Data Space: Annex I now includes information on the relevance of interoperability and data security, particularly in the context of electronic health records (EHRs).
- Addition of an example for Class I MDSW: Annex IV includes a new practical example to support implementation by manufacturers.
Revision 1 aims to adapt the guideline to the regulatory landscape and the practical challenges of MDSW approval.
