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Medical device software

Qualification, classification, evaluation, or distribution of medical device software.

Official catalogue · non-binding

Medical device software guidance (9)

Catalogue entries are ordered as they appear in the European Commission catalogue.

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MDCG 2025-9Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026December 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
December 2025
Topics

Source document

  • MDCG 2025-9PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.

MDCG 2025-6FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)June 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
Topics

Source document

  • MDCG 2025-6PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.

MDCG 2025-4Guidance on the safe making available of medical device software (MDSW) apps on online platformsJune 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
Topics

Source document

  • MDCG 2025-4PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.

MDCG 2023-4Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware componentsOctober 2023
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
October 2023
Topics

Source document

  • MDCG 2023-4PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.

InfographicIs your software a Medical Device?March 2021
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
March 2021
Topics

Source document

  • InfographicPDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.

MDCG 2020-1Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device softwareMarch 2020
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
March 2020
Topics

Source document

  • MDCG 2020-1PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.

MDCG 2019-16 rev.1Guidance on cybersecurity for medical devicesJuly 2020
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
July 2020
Topics

Source document

  • MDCG 2019-16 rev.1PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.

MDCG 2019-11 rev.1Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746June 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
Topics

Source document

  • MDCG 2019-11 rev.1PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.

Show all 9 guidance documentsShow only the first 8
MDCG 2018-5UDI assignment to medical device softwareOctober 2018
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
October 2018
Topics

Source document

  • MDCG 2018-5PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.