State of the art (SOTA)

The MDR uses the state of the art throughout the general safety and performance requirements and the clinical evaluation, as the benchmark a device is judged against. Manufacturers have to describe it for their field, including alternative treatments, and update it as practice changes.

developed stage of technical capability at a given time as regards products, processes (3.14) and services, based on the relevant consolidated findings of science, technology and experience Note 1 to entry: The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the “generally acknowledged state of the art”. [SOURCE: ISO/IEC Guide 63:2019, 3.18]

ISO 14971:2019, clause 3.28

• ‘state of the art’: IMDRF/GRRP WG/N47 provides the following definition: Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, based on the relevant consolidated findings of science, technology and experience. Note: The state-of-the-art embodies what is currently and generally accepted as good practice in technology and medicine. The state-of-the-art does not necessarily imply the most technologically advanced solution. The state-of-the-art described here is sometimes referred to as the “generally acknowledged state-of-the-art

MDCG 2020-6, Section 1.2, Additional terms not defined in MDR Article 2 (definition from IMDRF/GRRP WG/N47)

State of the art should be understood as: Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, based on the relevant consolidated findings of science, technology and experience.

MDCG 2025-10, Footnote 14 (source: IMDRF/GRRP WG/N47)

Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, based on the relevant consolidated findings of science, technology and experience. Note: The state-of-the-art embodies what is currently and generally accepted as good practice in technology and medicine. The state-of-the-art does not necessarily imply the most technologically advanced solution. The state-of-the-art described here is sometimes referred to as the “generally acknowledged state-of-the-art”

MDCG 2022-2, Section 4, Definitions (modified from IMDRF/GRRP WG/N47 FINAL:2018)

Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, based on the relevant consolidated findings of science, technology and experience. Note: The STATE-OF-THE-ART embodies what is currently and generally accepted as good practice in technology and medicine. The state-of-the-art does not necessarily imply the most technologically advanced solution. The STATE-OF-THE-ART described here is sometimes referred to as the “generally acknowledged STATE-OF-THE-ART”

MDCG 2020-1, Section 3.3, Definitions (modified from IMDRF/GRRP WG/N47 FINAL:2018)