In the coming years, the current legal regulations with regard to the medical devices market (the Polish Act on Medical Devices, which implements the EU device directives) will be replaced by two directly applicable EU regulations – the regulation regarding medical devices (MDR) and the regulation regarding in vitro diagnostic medical devices (IVDR). The regulations include many changes important for the industry, including new provisions of law on clinical tests, supervision over the marketing of devices (e.g. European EUDAMED database) or device labelling (UDI codes).
Our Law Office offers full support for medical companies in the field of preparation for the application of new regulations - from training on new rules to conducting internal audits and preparation of appropriate documentation, procedures and agreements (e.g. it will be necessary to modify some distribution agreements to enable “tracking” of the device).