MDCG 2019-11 rev. 1 pub­lished by the Euro­pean Commission

Back­ground

In Octo­ber 2019, the EU’s Med­ical Device Coor­di­na­tion Group (MDCG) intro­duced MDCG 2019-11, Guid­ance on Qual­i­fi­ca­tion and Clas­si­fi­ca­tion of Soft­ware in Reg­u­la­tion (EU) 2017/745 – MDR and Reg­u­la­tion (EU) 2017/746 – IVDR, to pro­vide clar­i­ty on how soft­ware qual­i­fies as a med­ical device under the Med­ical Devices Reg­u­la­tion (MDR) or IVD Med­ical Devices Reg­u­la­tion (IVDR). A revised ver­sion, revi­sion 1, was endorsed in June 2025 to align bet­ter with cur­rent reg­u­la­to­ry practice.

Pur­pose

This guid­ance serves sev­er­al crit­i­cal functions:

• Qual­i­fi­ca­tion cri­te­ria – Defines Med­ical Device Soft­ware (MDSW) based on its intend­ed purpose.
• Clas­si­fi­ca­tion rules – Offers prac­ti­cal guid­ance on apply­ing annex VIII rules—especially Rule 11 for MDR and Rules 1.4/1.9 for IVDR—to prop­er­ly cat­e­go­rize MDSW (typ­i­cal­ly at least Class IIa or IIb).
• Mar­ket place­ment guid­ance – Explains when soft­ware is placed on the mar­ket inde­pen­dent­ly or inte­grat­ed as a part or com­po­nent of a med­ical device, and the asso­ci­at­ed con­for­mi­ty assess­ment expectations.

Key Updates in Revi­sion 1 (June 2025)

• Expand­ed scope for Arti­fi­cial Intel­li­gence-based MDSW.
• Strength­ened focus on the intend­ed pur­pose irre­spec­tive of soft­ware loca­tion (mobile, cloud, embedded).
• Clar­i­fied “soft­ware dri­ving or influ­enc­ing a device” and its impact on classification.

The guid­ance can be down­loaded from our web­site.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Medtech com­pa­nies fac­ing risk of non-com­pli­ance as EU AI dead­lines approach
• EU noti­fied bod­ies on har­monised stan­dards regard­ing cybersecurity
• Guid­ance on Qual­i­fi­ca­tion and Clas­si­fi­ca­tion of Soft­ware under the MDR and IVDR Published