MIVDR ReaderEU medical device regulations
Home

Readability & Display

Unofficial consolidated textConsolidated 2026-01-01English

Article 94

Reproduced from official EUR-Lex 1/1/2026.

Article 94

Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance

Where the competent authorities of a Member State, based on data obtained by vigilance or market surveillance activities or on other information, have reason to believe that a device:

  1. (a)

    may present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health; or

  2. (b)

    otherwise does not comply with the requirements laid down in this Regulation,

they shall carry out an evaluation of the device concerned covering all requirements laid down in this Regulation relating to the risk presented by the device, or to any other non-compliance of the device.

The relevant economic operators shall cooperate with the competent authorities.

Official catalogue · non-binding

Related guidance (2)

Current English catalogue entries that refer to Article 94. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2022-18MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificateDecember 2022
Non-binding guidanceOpen guidance page
Catalogue section
Other topics
Published
December 2022
Topics

Source document

  • MDCG 2022-18PDF · 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 2021-25 rev.1Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EECOctober 2024
Non-binding guidanceOpen guidance page
Catalogue section
Other topics
Published
October 2024
Topics

Source document

  • MDCG 2021-25 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.

Reader references