The work in the Parliament on the draft of the new Law on Medical Devices has been completed. The Act has now been sent to the President of Poland for signature. The new act is set to come into force on 26 May 2022, at which time the existing Act of 20 May 2010 on medical devices will also expire. But can the medical device industry say goodbye to the current rules for good?
It is important to note that until the moment when registration in the EUDAMED system becomes obligatory and until the national register of distributors is launched, the obligation to submit notifications and notifications of medical devices to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (“URPL”) remains in place.
Notifications by manufacturers and notifications by importers will continue as before until registration with EUDAMED becomes mandatory, which is expected to be as late as 2025. For distributors, on the other hand, notifications are to be made by July 1, 2023, i.e. by the time the new rules for the national register of distributors come into force.
In addition, there is also an obligation to make notifications in the event that an entity fails to register in the EUDAMED database or in the list of distributors, respectively.❰ Powrót do News