MDR/IVDR Requirements about the Evaluation of Devices with Unacceptable Risk/Non-Compliance

Article 94 MDR and article 89 IVDR mention the requirements for the evaluation of devices suspected of presenting an unacceptable risk or other non-compliance aspect.

Concretely, based on data obtained by market surveillance activities and/or vigilance, the competent authorities of a Member State have the right and shall carry out an evaluation of a device if they have reason to believe that the device concerned may present an unacceptable risk or does not comply with the MDR or IVDR.

Both articles have the same requirements (See Comparison Table below).

Comparison Table

Differences are in orange.

EU MDR – Regulation (EU) 2017/745
EU IVDR – Regulation (EU) 2017/746

Article 94

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

Article 89

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:

(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

(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.

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:

(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

(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.

References

Regulation (EU) 2017/745 MDR: 02017R0745 — EN — 24.04.2020 — 001.001 (consolidated version)

Regulation (EU) 2017/746 IVDR: 02017R0746 — EN — 05.05.2017 — 000.003 (consolidated version)

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