Article 95 MDR and article 90 IVDR mention the requirements for the procedure of devices suspected of presenting an unacceptable risk or other non-compliance aspect. Both articles have the same requirements (See Comparison Table below).
Concretely, if the output of the evaluation pursuant to article 94 MDR/article 89 IVDR concludes that a device presents an unacceptable risk to the health or safety of the patients or users, the competent authorities of a Member State have the right and shall, without delay, required the economic operators (EOs) to take all appropriate and duly justified corrective actions (CAs) to bring the device into compliance with the requirements of the MDR/IVDR.
The CAs taken should be based on the risk presented by the device and should be proportionate to the nature of the risk. If adequate CAs are not taken by the EOs, the competent authorities shall take all appropriate measures to prohibit or restrict the making available of the device on their national market, to withdraw the device from that market or to recall it.