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New MDCG 2023-4 guidance: Medical Device Software (MDSW) - Hardware combinations

Medical devices regulation

This document, titled "MDCG 2023-4 Medical Device Software (MDSW) – Hardware Combinations," provides guidance on medical device software (MDSW) that works in combination with hardware or hardware components. Here's a summary of its key points:

Scope of the Guidance document

- Aims to clarify regulatory considerations when hardware components are used in conjunction with MDSW.

- Examines scenarios where hardware is considered a medical device or an accessory and where it is not.

- Excludes discussions on clinical evaluation and cybersecurity, which are covered in separate guidance.

Hardware and MDSW Combinations:

- Discusses examples where hardware components provide input data to MDSW.

- Differentiates between scenarios where the hardware manufacturer is the same as the MDSW app manufacturer and when they are different entities.

- Explains how physiological data is collected, processed, and potentially transmitted to healthcare professionals.

Regulatory Considerations:

- Emphasizes that MDSW and hardware cannot achieve a medical purpose on their own.

- Manufacturers must claim a medical purpose for MDSW and provide evidence of compliance with the regulations.

- Lists options for placing MDSW and hardware on the market, including as medical devices, accessories, or consumer products.

Placement on the Market:

- Details regulatory requirements for MDSW and hardware based on the options chosen.

- Highlights the importance of verifying safety, performance, compatibility, and interoperability.

- Discusses risk management and post-market surveillance for different scenarios, including when MDSW and hardware are from different manufacturers.

Key takeaways from the MDCG document:

- Growing Role of Medical Device Software (MDSW): MDSW is increasingly important in the medical device landscape, with many devices relying on it. It often works in combination with hardware to achieve its intended purpose.

Regulatory Considerations: The document addresses the regulatory considerations when MDSW and hardware interact. Manufacturers must claim a medical purpose for MDSW and ensure compliance with regulations.

Options for Market Placement: Manufacturers have options for placing MDSW and hardware on the market, such as as medical devices, accessories, or consumer products.

Safety and Performance Requirements: Regardless of the situation (MD software + MD hardware or MD accessory - or else - MD software + non-MD hardware), safety, performance, compatibility, and interoperability are critical factors to consider.

Risk Management and Post-Market Surveillance: Manufacturers must establish risk management plans and actively monitor both MDSW and hardware (MD or non-MD) to ensure their safety and performance throughout their lifecycle. This includes addressing malfunctions, use errors, and other risks.

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