The new Act on medical devices and diagnostic medical devices in vitro
A comprehensive act regulating both the MDs and IVDs is finally here. The new Act No. 375/2022 Coll., on medical devices and in vitro...
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Aneta Dostálová
Nov 16, 2022
What the new European Regulation 2022/123 brings in the field of medicines and medical devices
New Regulation of the European Parliament and of the Council (EU) 2022/123 of 25 January 2022 on reinforced role for the European...
Jakub Král
Nov 16, 2022
Free shipping advertising is limited for mail order dispensing
The issue of mail-order dispensing of medical devices has been an evergreen in recent years. While mail-order dispensing of prescription...
Jakub Král
Oct 16, 2022
The discussion platform at the Ministry of Health is beginning to bear fruit
In recent years, conflicts between VZP and suppliers have been escalating over the inclusion of separately charged material (ZUM) in the...
Veronika Moravová
Oct 13, 2022
Translations of instructions for use: an intractable problem for importers and distributors
Soon we will be moving into the second half of the transition period for "flipping" legacy devices into MDR mode. Unfortunately, as...
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