MDCG 2023-4: Medical Device Software (MDSW) – Hardware Combinations

The official title of MDCG 2023-4 is Medical Device Software (MDSW) – Hardware combinations: Guidance on MDSW intended to work in combination with hardware or hardware components.

Published in October 2023, the guidance explains the regulatory considerations that apply when Medical Device Software relies on hardware, sensors, cameras or other hardware components to achieve its intended medical purpose.

It distinguishes between hardware placed on the market as a medical device or accessory and hardware incorporated into a general consumer product with no intended medical purpose. This distinction affects the evidence, technical documentation, risk management and post-market responsibilities of the MDSW manufacturer.

Download the official MDCG 2023-4 guidance

What Is the Scope of MDCG 2023-4?

MDCG 2023-4 applies to Medical Device Software that needs data or signals from hardware or a hardware component to achieve its intended medical purpose.

Examples include an MDSW application that receives physiological data from:

• a sensor embedded in an external dermal patch;
• a sensor incorporated into a smartwatch or other wearable;
• a camera or sensor integrated into a smartphone;
• hardware placed on the market by the MDSW manufacturer;
• compatible hardware supplied by a different manufacturer.

For the purposes of this guidance, hardware does not include desktop computers or cloud computing platforms such as servers.

The guidance does not elaborate on clinical evaluation or cybersecurity. These subjects are addressed in other MDCG guidance, including MDCG 2020-1 for the clinical or performance evaluation of Medical Device Software and MDCG 2019-16 for medical device cybersecurity.

Why Does the MDSW-Hardware Combination Matter?

Some MDSW cannot achieve their intended medical purpose without input from a specific hardware component. The software may process measurements such as body temperature, oxygen saturation or heart rate and then calculate, display or transmit medical information.

In these circumstances, the regulatory assessment cannot consider the software and hardware interaction only at a conceptual level. The manufacturer must verify, validate and demonstrate that the combination produces safe, effective and reliable results.

This assessment must consider the intended configurations and variants of the hardware used with the MDSW.

The Three Regulatory Options Under MDCG 2023-4

MDCG 2023-4 identifies three ways in which the hardware or hardware component may be placed on the market.

Option 1: Hardware Placed on the Market as an Accessory to MDSW

Under the first option, the hardware or hardware component is placed on the market as an accessory to the Medical Device Software.

The hardware is therefore subject to the applicable MDR requirements. Its risk classification follows Annex VIII of the MDR.

Option 2: Hardware Placed on the Market as a Medical Device

Under the second option, the hardware or hardware component is placed on the market as a medical device:

• as part of a system under Article 22 of the MDR;
• in combination with another medical device under Article 2(1);
• or as an integral part of a medical device.

In both Options 1 and 2, the MDSW manufacturer may rely on the hardware manufacturer’s demonstrated MDR conformity when the hardware is used according to its intended purpose and under its intended normal conditions of use.

This does not remove the MDSW manufacturer’s responsibility for demonstrating that the complete combination works safely and as intended.

Option 3: Hardware Is Part of a General Consumer Product

Under the third option, the hardware or hardware component is incorporated into a general consumer product or wearable and has no intended medical purpose. It is not placed on the market as a medical device or as an accessory to a medical device.

Examples may include sensors incorporated into a consumer smartwatch or smartphone.

In this situation, the MDSW manufacturer cannot rely on the hardware’s compliance with the MDR. The manufacturer becomes responsible for the safety, performance and reproducibility of the hardware when it is used in combination with the MDSW across all intended configurations.

MDCG 2023-4 states that the manufacturer must meet requirements under conditions equivalent to those applying when a medical device is combined with another product under Article 22(4) of the MDR.

Requirements When the Hardware Is a Medical Device or Accessory

For Options 1 and 2, the MDSW manufacturer must demonstrate compliance with the MDR, including the applicable General Safety and Performance Requirements in Annex I.

The manufacturer must verify, validate and demonstrate:

• safety;
• performance;
• reproducibility;
• compatibility;
• interoperability;
• correct operation across the intended hardware configurations and variants.

The clinical evaluation of the MDSW must address the intended medical purpose achieved through the combination.

Risk management and post-market surveillance must also include appropriate communication channels with the hardware manufacturer. These channels should allow changes, incidents and other information affecting the combined product to be communicated and assessed efficiently.

Additional Responsibilities When Using Consumer Hardware

Option 3 creates additional responsibilities because the hardware manufacturer has not demonstrated conformity with the MDR.

The MDSW technical documentation must clearly identify and describe every consumer product, hardware component and intended configuration required for the software to achieve its medical purpose.

The MDSW manufacturer must also:

• document a risk management plan covering the MDSW-hardware combination;
• demonstrate clinical evidence for all intended configurations;
• assess hardware performance, reliability and reproducibility;
• monitor compatibility and interoperability throughout the MDSW lifecycle;
• evaluate hardware changes, malfunctions and reasonably foreseeable use errors;
• establish controls for monitoring the proper functioning of the hardware;
• implement appropriate risk controls and mitigation measures;
• assess market information concerning hardware that could affect MDSW safety or performance.

Verification of compatibility alone is not sufficient. The manufacturer remains responsible for demonstrating that the combined use is safe and performs as intended.

MDCG 2023-4 Manufacturer Checklist

Before placing an MDSW-hardware combination on the EU market, confirm that:

• The intended medical purpose of the MDSW is clearly documented.
• The role of the hardware in achieving that purpose is described.
• Every supported hardware configuration and variant is identified.
• The regulatory status of each hardware component is established.
• Compatibility and interoperability requirements are specified.
• Safety, performance and reproducibility have been verified and validated.
• Clinical evidence covers the intended combinations and configurations.
• The risk management file addresses hardware failures and use errors.
• Hardware changes that could affect the MDSW can be identified and assessed.
• Post-market surveillance covers both the MDSW and relevant hardware behaviour.
• Communication mechanisms with third-party hardware manufacturers are established where applicable.
• The technical documentation explains how unsupported or changed configurations will be controlled.

Frequently Asked Questions

Need Support With an MDSW-Hardware Regulatory Strategy?

Correctly defining the regulatory status of the hardware is only the starting point. Manufacturers must also establish the required evidence, validation, technical documentation, risk controls and post-market processes for the complete combination.

MDx CRO supports manufacturers with MDSW qualification, MDR regulatory strategy, clinical evidence planning, technical documentation, risk management and lifecycle compliance.

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