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Article 65

Reproduced from official EUR-Lex 10/1/2025.

Article 65

Damage compensation

1.

Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a performance study conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk.

2.

The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form appropriate for the Member State in which the performance study is conducted.

Official catalogue · non-binding

Related guidance (2)

Current English catalogue entries that refer to Article 65. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2025-5Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746June 2025
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
June 2025
Topics

Source document

  • MDCG 2025-5PDF · 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.

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.

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