Juni 25, 2025
Software Regulatory

Who Determines the Standards for Software Qualification?

MDCG 2019-11 revision 1, focusing on the qualification and classification of software under the Medical Device Regulations (EU) 2017/745 and (EU) 2017/746, has been updated and is now available. This revision clarifies the criteria for qualifying software as a medical device, including Medical Device Artificial Intelligence (MDAI), and provides guidance on applying the classification rules to medical device software (MDSW). The update also addresses the placement of MDSW on the market and includes information on the evolving European Health Data Space (EHDS) regulation. 

 

Here's a breakdown of the key changes and updates:

The revision clarifies the scope of the document, particularly regarding Annex XVI software and the definition of "intended purpose". It also removes the term "standalone software" in favor of a function-centric approach. 


Classification Rules

Rule 11 Clarification: The revision provides further clarification on Rule 11, particularly sub-rule (a), which deals with software used for diagnostic or therapeutic decision-making. 

Higher Risk Classes: The guidance highlights scenarios where MDSW that influences clinical prognosis or prediction could be classified as higher risk, reflecting the increasing regulatory focus on tools that impact patient management.

Annex XVI Examples: Additional examples are provided to help manufacturers determine whether non-medical purpose software (e.g., wellness apps) falls under the MDR through Annex XVI.


European Health Data Space (EHDS)

The update acknowledges the interplay between the MDR/IVDR and the EHDS regulation, especially for electronic health record systems. Manufacturers of such systems should expect increasing emphasis on data portability and structured exchange.


General Updates

Intended Purpose: The revision emphasizes the importance of a clear intended purpose for the software, regardless of its location or platform. 

Modular MDSW: The guidance includes considerations related to modular MDSW. 

Examples: New examples are added to illustrate the application of the guidance to different types of MDSW.


The updated MDCG 2019-11 revision 1 is available for download from the European Commission website (external link).