Software now under the scope of the IVDR

With the addition of the term “software” in the definition of in vitro diagnostic medical device (IVDR 2017/746, Article 2 - Definitions, 2.), software is now included in the scope of the IVDR and thus finally receives the attention it deserves:

“‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following [...]”

The term medical device software covers numerous devices that are applied in a therapeutic or diagnostic context; against the background of digitization in health care, their importance is increasing significantly. Primarily it refers to software IN medical devices, also referred to as embedded software, but also to software AS a medical device, so-called stand-alone software.

Manufacturers of medical devices and in vitro diagnostic medical devices are faced with the challenge to develop cost-efficient products of high quality that comply with the regulations. Both IVDR and MDR require manufacturers to ensure their devices’ safety and the expectations of software documentation are also high. Especially small and medium-sized businesses often experience a lack of resources and insufficient knowledge of general regulatory requirements.

As your holistic service provider we guide you through all stages of your devices’ software life cycle – competent and reliable.

... and what does “holistic” mean?

"Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a "medical device" in the medical devices regulation or in vitro diagnostic medical devices regulation."
Source: MDCG, "Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR", 2019.

Software: Product life cycle

Please click for an explanation of the figure:

+1 - Intended use

Intended use of the IVD medical device

+2 - Classification (software safety classification)

Software classification based on the risks associated with the software considering measures of risk governance implemented outside the software with a focus on expectable damage.

+3 - Requirements analysis

Systematically deriving the software requirements from the system requirements. For stand-alone software, the software requirements are identical to the system requirements.

+4 - Architecture

Organizational structure of a system or a component (EN 62034).

+5 - Detailed design

Detailed continuation of the system architecture to a specific solution for implementation.

+6 - Verification

Confirmation, through provision of objective evidence, that specified requirements have been fulfilled. (EN 62304).

+7 - Validation

Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled (EN 82304-1).

Regulatory requirements of medical software

Safety requirements

Safety: Protection against device malfunctions due to software failures,

Security: Protection of the software against hacker attacks and attacks from outside,

Privacy: Compliance with the requirements in terms of data privacy.
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The regulatory requirements are derived from the in vitro diagnostic regulation (IVDR). The general safety and performance requirements in Annex I, Chapter 2 define that a software life cycle must be established; it is adequately reflected in EN 62304.

However, IEC 62304 does not provide answers to all questions. For example, it does not regulate the validation of a device or the electrical safety of devices with embedded software. In addition, other standards such as EN 61010, EN 62366 or IEC 82304 must be observed.

The next obstacle: Although the standards mentioned above reflect the current state of the art, not all of them are necessarily harmonized, neither with the IVDD and certainly not with the IVDR. It is therefore always recommended to consult with your notified body before applying non-harmonized standards.

Software may be an individual medical device enabling diagnostic decisions. It may, however, also be part of a whole, for example as firmware in almost any complex medical device. And also complex production processes are virtually impossible without software today.

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