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Article 97

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

Article 97

Other non-compliance

1.

Where, having performed an evaluation pursuant to Article 94, the competent authorities of a Member State find that a device does not comply with the requirements laid down in this Regulation but does not 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, they shall require the relevant economic operator to bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non-compliance.

2.

Where the economic operator does not bring the non-compliance to an end within the period referred to in paragraph 1 of this Article, the Member State concerned shall, without delay, take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market. That Member State shall inform the Commission and the other Member States, without delay, of those measures, by means of the electronic system referred to in Article 100.

3.

In order to ensure the uniform application of this Article, the Commission may, by means of implementing acts, specify appropriate measures to be taken by competent authorities to address given types of non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Official catalogue · non-binding

Related guidance (6)

Current English catalogue entries that refer to Article 97. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2021-1 rev.1Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functionalMay 2021
Non-binding guidanceOpen guidance page
Catalogue section
EUDAMED
Published
May 2021
Topics

Source document

  • MDCG 2021-1 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 2022-16Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2022
Non-binding guidanceOpen guidance page
Catalogue section
Authorised Representatives, Importers, Distributors
Published
October 2022
Topics

Source document

  • MDCG 2022-16PDF · 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.

Q&A rev.2Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periodsJuly 2024
Non-binding guidanceOpen guidance page
Catalogue section
Other topics
Published
July 2024
Topics

Source document

  • Q&A rev.2PDF · 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 2022-18 ADD.1MDCG 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 certificate - Addendum 1June 2023
Non-binding guidanceOpen guidance page
Catalogue section
Other topics
Published
June 2023
Topics

Source document

  • MDCG 2022-18 ADD.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 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.

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