Poland: works on the MDR implementation at the national level

Since 26 May 2021, the Regulation (EU) 2017/745 on medical devices directly applies in Poland as the implementing law is yet to be introduced. Previously the Council Directive 93/42/EEC concerning medical devices was introduced into the Polish legal system by the Act of 20 May 2010 on medical devices and supplementary laws, which are currently still in force.

On 19 October 2021, the Council of Ministers adopted the draft law on medical devices submitted by the Minister of Health to adapt obsolete Polish rules to the new EU Regulation.

The critical solutions introduced by the new . . .


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