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Borderline regulatory status

Determination of whether a product falls within medical-device legislation or another regulatory framework.

Official catalogue · non-binding

Borderline regulatory status guidance (5)

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

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Manual on BorderlineManual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 Background note on the use of the Manual on borderline and classification for medical devices under the Directives.April 2026
Non-binding guidanceOpen guidance page
Catalogue section
Borderline and Classification
Published
April 2026
Topics

Source documents

  • Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5PDF · 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.

  • Background notePDF · 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 2024-13Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devicesOctober 2024
Non-binding guidanceOpen guidance page
Catalogue section
Borderline and Classification
Published
October 2024
Topics

Source document

  • MDCG 2024-13PDF · 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 2022-5 rev.1Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devicesOctober 2024
Non-binding guidanceOpen guidance page
Catalogue section
Borderline and Classification
Published
October 2024
Topics

Source document

  • MDCG 2022-5 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 2021-24 rev.1Guidance on classification of medical devicesApril 2026
Non-binding guidanceOpen guidance page
Catalogue section
Borderline and Classification
Published
April 2026
Topics

Source document

  • MDCG 2021-24 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.

Helsinki ProcedureHelsinki Procedure for borderline and classification under MDR & IVDRSeptember 2021
Non-binding guidanceOpen guidance page
Catalogue section
Borderline and Classification
Published
September 2021
Topics

Source document

  • Helsinki ProcedurePDF · 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.