Medical Devices Medical Device Coordination Group Document MDCG 2023-4 MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components October 2023 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law Page 1 of 8 Medical Devices Medical Device Coordination Group Document MDCG 2023-4 Table of Contents 1) Introduction ................................................................................................................. 3 2) Scope ......................................................................................................................... 3 3) Hardware or hardware component working in combination with MDSW...................... 4 A. External hardware component (e.g. sensor embedded in a dermal patch) providing input data to a MDSW app ............................................................................................. 4 B. Hardware component incorporated within a smartphone or wearable connected to a MDSW app on smartphone or wearable ......................................................................... 5 4) Regulatory considerations .......................................................................................... 6 5) Placement on the market ............................................................................................ 7 Page 2 of 8 Medical Devices Medical Device Coordination Group Document MDCG 2023-4 1) Introduction Software has become an increasingly important part of the medical device landscape. It is estimated that one in four medical devices either incorporate medical device software (MDSW)1 or are MDSW in their own right. With the broad public use of smart phones and wearable digital products, certain MDSW make use of a broad range of technologies in order to fulfil their intended purpose. This use has enabled patients and clinicians to engage with health information in an unprecedented manner. In many cases, MDSW can only achieve its intended purpose when it is used in combination with a hardware2 or hardware component (e.g., sensor) generating or providing input data. For example, MDSW downloaded or available on wearables (e.g. bracelets, smartwatches, virtual/augmented reality goggles) to prevent, predict or manage a disease, achieve their intended purpose by receiving and analysing data provided by a hardware or hardware component. In these cases, relevant hardware often incorporate components such as sensors and cameras, the information from which may be used in a variety of MDSW, including socalled medical device applications (MDSW apps). Sensors or other hardware components are in certain cases integral parts of general-purpose consumer electronics or wearable digital products. The interaction between the MDSW, hardware or hardware component (in particular integrated sensors) raise the question regarding the qualification and the appropriate regulatory pathway or conformity assessment of these hardware or hardware components. 2) Scope Through the provision of information and/or signals, these hardware or hardware components play an essential role in contributing to the medical purpose of certain MDSW. It is important to consider how the manufacturer of the MDSW has to demonstrate conformity with the applicable regulatory requirements for the combination of the MDSW and the concerned hardware or hardware components. This guidance intends to examine and provide clarifications on which specific regulatory considerations apply when the hardware or hardware component incorporating the data collection element (camera, electrical/optical sensors etc.) are a medical device or an accessory to a medical device. This guidance also outlines scenarios where the hardware or 1 For more detailed information regarding software qualification and classification, refer to MDCG 2019-11. For the purposes of this document, hardware should not be understood