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Software and the use of Artificial Intelligence in the Medical Devices Business

By 18 de January de 2026No Comments

As in other industries, in Healthcare the exponential development of artificial intelligence enables advances both at the product level and at the level of administrative management.

At the product level, applications are being developed to assist in medical diagnosis, patient monitoring, etc., and, on the other hand, applications to facilitate the administrative management of patient data and communication with patients in healthcare centers, pharmacies, etc.

Regarding administrative management in companies that develop and manufacture these devices, those advances in IT are helping to reduce the more documentary and routine activities.

Biondec (www.biondec.com) is committed to this trend in software development. On the one hand, we support companies that develop tools to help clinicians and patients by advising them on quality and regulatory compliance. On the other hand, we develop or facilitate applications that reduce administrative activities and/or help automate certain tasks within the Quality Management System of those companies; this allows users of these systems to dedicate more time to higher value-added activities, reducing lead times and ensuring greater efficiency.

In the following article we will review regulations and standards in the European Union relating to both major software groups:

Software intended to Quality Management:

ISO 13485:2016 requires that organization has procedures for validation of software used in the Quality Management System (section 4.1.6) and software use in production and/or service provision (section 7.5.6) and it must be validated before prior use, both initially and after changes. Validation and revalidation must be proportional to risk associated with their use including impact on quality of products (or their ability to meet specifications). All that must be recorded.

Software as a Medical Device (MDSW):

Medical Devices incorporating software must comply with:

  • Regulation (UE) 2017/745 regarding medical devices (MDR) or 2017/746 for medical devices for in vitro diagnosis(IVDR), as applicable, and
  • In case of incorporating artificial intelligence, they must also comply with Regulation (UE) 2024/1689, that establishes harmonized requirements on artificial intelligence (IA).

There are several guides elaborated by MDCG to clarify concepts with examples for application of MDR and IVDR requirements for software as medical device.

  • MDCG 2019-11 Rev.1 “Guidance on qualification and classification of software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”:

Guide published on 2025 according to MDR, IVDR and the Digital Services Law. This guide updates about software classification as a medical device or medical device for in vitro diagnosis.

  • MDCG 2025-4 “Guidance on the safe making available of medical device software (MDSW) apps on online platforms”

This guide clarifies function and responsibilities of providers for software applications platforms and information that manufactures must provide when commercializing these software.

  • MDCG 2023-4: “Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components”

In addition, there is a FAQs document regarding the simultaneous application of requirements established in Regulation (UE) 2024/1689 and MDR and IVDR. The Artificial Intelligence Board (AIB) and the Medical Devices Coordination Group (MDCG) have jointly elaborated this document:

References: