Safety of Medical Devices in Poland – Analysis of Withdrawn and Suspended Certificates of Compliance

摘要

In the European Union, the process of controlling currently used medical devices is carried out and determined by legal provisions. The law stipulates that each entity responsible for using medical equipment must confirm its safety with an appropriate certificate issued by a notifying body. In Poland, the entity responsible for keeping records as to the withdrawn and suspended certificates, is the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL). Certification is required for all medical devices prior to their introduction onto the market and during their use.