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Unofficial consolidated textConsolidated 2025-01-10English

Article 57

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

Article 57

General requirements regarding performance studies

1.

The manufacturer shall ensure that a device for performance study complies with the general safety and performance requirements set out in Annex I apart from the aspects covered by the performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient, user and other persons.

2.

Where appropriate, performance studies shall be performed in circumstances similar to the normal conditions of use of the device.

3.

Performance studies shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in such performance studies are protected and prevail over all other interests and the data generated are scientifically valid, reliable and robust.

Performance studies, including performance studies that use left-over samples, shall be conducted in accordance with applicable law on data protection.

Official catalogue · non-binding

Related guidance (2)

Current English catalogue entries that refer to Article 57. 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 2022-10Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)May 2022
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
May 2022
Topics

Source document

  • MDCG 2022-10PDF · 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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