Croatia has started presiding the Council of the European Union on the 1st of January 2020, and will remain in this role until the 30th June 2020, when Germany takes over.
As the MDR becomes applicable in ~ 4 months, Croatia will be organizing and chairing several committees’ and working groups’ meetings to address the implementation of the Regulation on medical devices throughout this period. Further information can be found on the website of the Croatian Competent Authority (HALMED).
We would also like to bring you attention to the fact that the EU Member States are in the process of adopting and publishing national implementing legislation of the MDR, and we are collecting them for you in our Library of documents, in the icon ”LAW”. These typically address language requirements, reprocessing of single-use devices, labelling of sterile devices, liability and other provisions, where Member State have the right to adopt provisions – as prescribed by the Regulation – for their specific jurisdiction.