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The Ministry of Health held another meeting on price and reimbursement regulation
On Monday 19 June 2023, another meeting of the platform at the Ministry of Health took place, where representatives of regulators, health...
Jakub Král
Jul 19, 2023


Instructions for use - software and sterile devices
When discussing medical device regulation, it is often said that Class I and IIa devices do not need to be accompanied by instructions...
Aleš Martinovský
Jul 19, 2023


The European Commission's document on the new MDR transition periods addresses some contentious issues
On 20 March 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council came into force, amending the MDR and IVDR. The...
Veronika Moravová
Mar 31, 2023


EMA Expert Panels to Begin with Pilot Projects
For a long time, nothing has been heard about the consultation process for clinical investigation of high-risk devices. As a reminder,...
Aleš Martinovský
Mar 23, 2023


Are you bothered by nonsensical temperature compliance requirements during distribution?
There is a growing tendency in the field of medical device to shift responsibilities from the manufacturer to the rest of the...
Aleš Martinovský
Feb 24, 2023


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