If an importer or distributor suspects that a product does not comply with the requirements of MDR or IVDR, they should immediately inform the manufacturer and authorized representative. In cases where a device is believed to be adulterated or may pose a serious risk, it is also necessary to inform the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, as well as the revelant authorities of other countries where the device has been distributed.
For devices already on the market, cooperation with the authority and the manufacturer is essential to efficiently resolve the issue and ensure compliance. If necessary, importers and distributors should take appropriate measures, such as withdrawing the product from the market or ceasing its use.