🔴Obligation to update data in the list of distributors of devices, systems or treatment sets and manufacturers of custom-made products.
📍Distributor of devices, systems or treatment sets established in the territory of the Republic of Poland.
Entity and person carrying out therapeutic activity and other entities that use medical devices for business or professional activity medical devices imported into the territory of the Republic of Poland
📍The manufacturer of a custom-made device, the authorised representative of a manufacturer of a custom-made device not residing or established in a Member State and the importer of a custom-made device
-are obliged to inform the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of :
🔺a change in the name or address of the entity, which is not accompanied by a change in the tax identification number (VAT);
🔺transfer of obligations to another entity, in particular due to transformation, declaration of bankruptcy or assumption of legal rights and obligations.
📍The deadline for notification of the change is 7 days from the date on which the change occurs.
🔴Failure to complete the data or correct them within the deadline set by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is tantamount to failure to submit the data to the list and the ICT system and is threatened by an administrative fine of up to PLN 200,000.