We would like to inform you, that from May 26, 2021, amendments to the EU regulations in the field of medical devices enter into force.
Rules govern the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EE
Therefore, we recommend an thorough analysis of the coming legal act and adapting to its requirements, taking into account the transition periods specified in this legal act.
The new Law on Medical Devices should also be expected to enter into force soon. It is still in the design phase, but will introduce new requirements consistent with Regulation 2017/745.
Please keep abreast of any changes in this regard.
We will gladly answer your questions about the requirements imposed on entrepreneurs of medical devices by the new regulations.