There has been an update to the guidance document MDCG 2019-11 concerning Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. originally released in 2019, this guidance document, aimed primarily at Medical Device Software (MDSW) manufacturers, offers guidance on the following:
- Criteria for qualifying software under the Medical Device Regulations, including Medical Device Artificial Intelligence (MDAI).
- How to apply classification criteria from the Medical Device Regulations to MDSW.
- Information regarding the process of placing MDSW on the market.
The criteria outlined in this document also apply to applications (apps), regardless of their platform—whether they run on a mobile phone, in the cloud, or on other platforms.
The updates in this document include:
- Section 1. Scope clarification
- Section 3. Addition of considerations related to the importance of crafting a clear intended purpose and references to modular MDSW
- Section 3.1. Clarifications on the scope of document with regards to Annex XVI software
- Section 3.2. Addition of new examples, including MDSW intended to treat.
- Section 4.2.1. Addition of clarification to Rule 11 (Subrule a). Addition of references and examples on devices intended to prevent the risk of illness […].
- Section 7. Update and further elaboration on ‘Modules’
- Annex I c.1. Update to reflect the interplay with the European Health Data Space Regulation with regard to Electronic Health Record Systems.
- Annex IV Inclusion of a new Class I example
The updated document can be accessed using the following link
