A device may be placed on the market only if it complies with the requirements of the MDR. To do so, prior to placing a device on the market, the manufacturers shall undertake an assessment of the conformity of the device in accordance with the applicable conformity assessment procedures.
As part of the provisions on market surveillance, the MDR lays down procedures on how competent authorities deal with devices that do not comply with MDR requirements (MDR Article 94). The competent authorities can carry out an evaluation if they believe that a device may present an unacceptable risk to health or safety, to the public health, or if the device does not comply with the requirements of the MDR.
If after this evaluation, the competent authorities finds that the device does not comply with certain MDR requirements but does not present an unacceptable risk to health, safety, or public health, the MDR Article 97 is applicable.
What is MDR Article 97?
Where after the evaluation, the competent authorities find that a device does not comply with the MDR requirements but does not present unacceptable risks, the manufacturer is required to bring the non-compliance to an end within a reasonable period proportionate to the non-compliance.
If the manufacturer fails, the Member State concerned restricts or prohibits the product being made available on the market or ensures that it is recalled or withdrawn.
This ensures that the conformity of the devices is established as soon as possible under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.
On December 2022, the Medical Device Coordination Group (MDCG) published the document MDCG 2022-18, related to the application of Article 97 to legacy devices for which the certificates issued under the old Directives expires before the issuance of the necessary certificate in accordance with the MDR.
The MDCG 2022-18 describes how competent authorities intend to apply the Article 97, as a temporary solution to avoid disruption of supply of devices on the EU market.
The MDCG 2022-18 applies to which devices?
The MDCG 2022-18 applies to devices that are or were considered ‘legacy devices’ (according to MDCG 2021-25). However, it only applies to devices that are ‘in transition’ from the Directives to the MDR or for which, despite reasonable efforts by the manufacturer, the relevant conformity assessment procedure involving a notified body has not been concluded in time.
It does not apply to devices for which the certificate issued under the Directives has been suspended or withdrawn. It does not apply to devices that have undergone a significant change in design or intended purpose.
Non-conformity, but no unacceptable risk to health and safety
The non-compliance should consist of the expiry of the Directive certificate and the risk that at that moment, the device will not be covered by a MDR certificate.
For the evaluation by the competent authority whether the (non-compliant) device presents an unacceptable risk, the manufacturer submits a report containing relevant data gathered through its post-market surveillance system (PMS), namely data concerning incidents, serious incidents and/or field safety corrective actions. Moreover, the manufacturer must demonstrate that it has adapted its quality management system to the MDR requirements.
Based on the information at its disposal, the competent authority concludes whether the device presents unacceptable risks to health or safety.
If the conclusion is that that the non-compliant device does not present an unacceptable risk to health and safety, MDR Article 97(1) is applicable.
End of the non-compliance in a reasonable period of time
The application of MDR Article 97(1) allow the manufacturer to bring the non-compliance to an end within a reasonable period of time.
Therefore, for these provisions to apply, the manufacturer should already have undertaken reasonable efforts to transition its device to the MDR. The ‘reasonable efforts’ means that an application for conformity assessment under the MDR have been accepted by a notified body and that there is a written agreement signed by notified body and manufacturer.
The competent authority may waive this condition if:
- The manufacturer is a SME
- The Directive certificate of that SME had been issued by a notified body not (yet) designated under the MDR
- The SME manufacturer demonstrate that it has undertaken efforts to apply to a considerable number of notified bodies and that their application has not been accepted due to limited notified body capacity.
The reasonable period by when the manufacturer should bring the device into compliance is set by the competent authority on a case-by-case basis and should not exceed 12 months but could be extended in justified cases.
Information to other parties and certificates of free sale
The device should not be subject to any change regarding its labelling, including CE marking. The manufacturer should inform its distributors and importers about the non-compliance and the measures undertaken. The competent authority may request the manufacturer to also inform the users.
Once the device may be placed on the EU market, certificates of free sale may be issued in accordance with national provisions with a validity not exceeding the period by when the manufacturer should bring the device in compliance with the MDR.