19 Oct 2021

Significant changes to Polish reimbursement law are on the way

A proposal for an amendment to the Reimbursement Act was published on 30 June 2021. The bill is currently undergoing public consultations and will be submitted to the Sejm for debate next year. The main changes to reimbursement regulations would concern: inclusion of pharmaceutical companies in the payback mechanism at the point when the reimbursement […]

30 Jun 2021

Legal developments concerning medical devices

On 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices (MDR) came into force, and this means revolutionary changes in many areas of the medical devices industry. The regulation changes current regulations concerning clinical trials for the most technologically advanced products. It also […]