Non-compliant products
Products suspected of not meeting the requirements of the MDR or IVDR regulations should not be brought to the market. Similarly, if an importer or distributor suspects that a product may be adulterated or pose a serious risk, marketing activities should be halted, and the situation should be documented.
Protocol for Suspected Non-compliant Products
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.
Handling of Serious Incidents
Importers and distributors are also obligated to report serious incidents that have occurred within Polish territory to the manufacturer or authorized representative. A serious incident refers to any event that resulted in or could have resulted in death, serious deterioration of the user’s health, or a threat to public health.
Notification of a Serious Incident – Medical Devices
The notification of a serious incident should include the following information:
- date and location of the incident
- number of affected patients, along with their age, weight, and gender data
- effects of the incident on the patients
- remedial or therapeutic actions taken to provide care to the patients
- device information, such as name, model, serial or factory number, UDI code, software version number, manufacturing date, expiration date, etc.
- number of devices associated with the serious incident
- current location of the product at the time of notification
- information about the individual involved at the time of the serious incident, including whether they were a professional user, patient, or any other person
- manufacturer’s, authorized representative’s, importer’s, or supplier’s details
- contact information of the person reporting the serious incident
The specific information requirements for a report on a serious incident are outlined in Article 48 of the Polish Medical Devices Act of April 7, 2022. To facilitate the reporting process, the Minister of Health has provided a standardized form for reporting serious incidents. Once the notification is completed and sent to the manufacturer, a copy is also sent to the President of the Office. However, if the importer or distributor has already received confirmation that the incident has been reported, there is no obligation to duplicate the notification.
Register of Complaints, Non-Compliant Device Notifications, and Recalls
Importers and distributors of medical devices are obligated to maintain a register of all notifications, complaints, and incidents received from entities to whom they have supplied devices, as well as complaints reported by patients and users directly. This information should be shared with the manufacturer, authorized representative, importer, or other distributors to facilitate their review and implementation of corrective measures. Additionally, the data should be made available to the authorities.
Non-compliance with the requirements for documenting complaints and notifications may result in fines.
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