New guidelines for medical software: What manufacturers and users need to know

The Medical Device Coordination Group (MDCG) published new guidelines on medical device software (MDSW) in October 2023. These guidelines comment on how medical software can be used in combination with hardware or hardware components.

The Medical Device Coordination Group (MDCG) is an important expert group in the field of medical device regulation in the European Union.

The objective of the opinion expressed in document 2023-4 is to ensure the safety and effectiveness of combinations of MDSW and to fulfil regulatory requirements.

All views expressed in the document are not legally binding and only the Court of Justice of the European Union can give a binding interpretation of Union law.

The contents of the MDCG 2023-4 document summarised:

Introduction and background

The MDCG, a group of representatives from all EU Member States, has published new guidelines on medical software (MDSW). These guidelines are not legally binding, but provide important guidance for manufacturers and users of medical software used in combination with hardware or hardware components.

Scope and objective

The guidelines cover various scenarios in which medical software is used with external hardware components or integrated into smartphones and wearables. The objective is to ensure that such combinations meet the high safety and performance requirements of the EU Medical Device Regulation (MDR).

Combination of MDSW with external hardware

An example of the combination of MDSW with external hardware is a dermal patch that contains sensors for recording physiological parameters such as body temperature, oxygen saturation (SpO2) and heart rate. This data is transmitted to an MDSW app on a smartphone, which analyses the data and forwards it to the user or directly to a healthcare provider.

Integration of MDSW in smartphones and wearables

Another scenario concerns the integration of MDSW in wearables such as smartwatches. Here, an integrated sensor collects physiological data that is processed and analysed by the MDSW app on the smartphone or the wearable itself. Here too, the data can be transmitted directly to a healthcare provider.

Responsibilities of the manufacturers

The guidelines emphasise the need for clear responsibilities between the manufacturers of the hardware components and the MDSW. It is recommended that both parties work closely together to ensure compliance with regulatory requirements and to guarantee the safety of users.

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MDSW as medical devices in the therapeutic or diagnostic field will become increasingly important in the coming years and revolutionise medicine as we know it. MEDIACC offers comprehensive services to support manufacturers in generating evidence through clinical studies and proving the safety and effectiveness of their products.

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