Revision of the MDCG 2019-11 guidance on the qualification and classification of software in MDR and IVDR

The MDCG has published a revision of the MDCG 2019-11 guidance, providing updates on the qualification and classification of medical software under both the MDR and IVDR.

Key changes introduced in Rev.1:

• Clarification of the document’s scope;
• Added guidance on the importance of crafting a clear intended purpose, including references to modular MDSW;
• New examples included, notably MDSW intended for treatment purposes;
• Clarified Rule 11 (Subrule a) with additional references and examples for devices intended to prevent illness;
• Expanded section on “Modules” with further elaboration;
• Annex I.c.1 updated to reflect the interplay with the European Health Data Space (EHDS) Regulation, particularly concerning Electronic Health Record Systems;
• New Class I device example added in Annex IV.

This revision is intended to help resolve implementation challenges in the transition from the Directives to the MDR, supporting greater consistency across the EU.

DOWNLOAD THE MDCG 2019-11 REV.1