MDCG 2019-11 Rev.1 provides guidance on the qualification and classification of software under the EU Medical Devices Regulation (MDR 2017/745) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). It is primarily intended as guidance for manufacturers to ensure that their software products comply with EU regulations.
Our FAQ explains the most important aspects of the MDCG Guidance Document 2019-11 Rev.1 of the Medical Device Coordination Group.
What is medical device software (MDSW) and how is it qualified?
MDSW is software with a medical purpose in accordance with MDR or IVDR. It can be used independently or in conjunction with devices. The decisive factor for qualification is the clearly defined intended purpose by the manufacturer. This also includes software that processes medical data or is an accessory for a medical device. The type of use (cloud, mobile, etc.) or the risk of potential damage is irrelevant. Examples: Apps for diagnosis, therapy planning or monitoring.
What is the difference between MDSW and software that drives a medical device?
MDSW has its own medical purpose. Control software only affects the function of a device but does not fulfil any medical purpose of its own. Both types are subject to the MDR but differ in terms of classification and assessment.
How is MDSW classified?
Classification is based on MDR/IVDR – in particular MDR Rule 11 (Annex VIII Section 6.4) – according to risk and influence on medical decisions:
- Class I: low risks.
- Class IIa–III: depending on the impact on health and treatment decisions.
MDSW, which drives the devices, must not be classified lower than the associated device (Annex VIII, Section 3.3).
What role does the intended purpose play?
The intended purpose is the central criterion for qualification and classification. It must be medically justified, clearly formulated and supported by technical documentation. Unclear or insufficient information can lead to incorrect classification and regulatory problems.
How do modular structures influence the assessment?
Each module is assessed separately. Only modules with a medical purpose are subject to MDR/IVDR. In the case of functional dependencies (e.g. medical module with non-medical user interface), the whole must be considered. Changes to modules may require a new qualification or classification.
How is the IMDRF risk classification applied?
The introduction of Rule 11 MDR is essentially based on the IMDRF guidelines. The clinical benefit of the software and the patient’s state of health are taken into account. Equivalents:
- IMDRF IV → MDR Class III
- IMDRF III → MDR Class IIb
- IMDRF I/II → MDR Class IIa
It is helpful, but only the MDR classification is legally binding.
How can MDSW be placed on the market?
MDSW can:
- be marketed independently as a medical device/in vitro diagnostic device (e.g. diagnostic apps) or
- as part of a device if it is integrated into a hardware product (e.g. control system in a blood analysis device).
The connection to the hardware does not change the qualification – the intended purpose remains decisive.
Which software does not count as MDSW?
Software without a medical purpose, such as billing tools, wellness apps, simple data storage or communication tools, do not count as MDSW. Systems that only display, store or forward data (e.g. HIS, PACS, LIS) are also not included, unless they interpret or influence medical decisions.
What should you do now?
- Clarify the medical purpose of your software at an early stage and check whether it is classified as MDSW.
- Determine the correct risk class precisely.
- Take standards such as IEC 62304, ISO 14971, IEC 82304–1, etc. into account from the outset – not just as an afterthought.
- Develop a documented quality management system.
- Ensure that software lifecycle processes are traceable and auditable.
Now is the right time to close regulatory gaps – only those who answer regulatory questions early on can bring MDSW products to market safely, economically and in compliance with the law. We are happy to support you. Get in touch with us.
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