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Do hospitals really want to produce in-house devices according to the MDR?
A major issue for healthcare providers is the application of Article 5(5) of the IVDR. The issue is that in many cases clinical...

Aleš Martinovský
Mar 14, 2024


The Platform of the Ministry of Health addresses comments on the methodology for inclusion of the ZUM in the VZP-ZP Reimbursement Catalogue
On Friday, 19 January 2024, the Ministry of Health held a meeting of the Stakeholder Platform on the issue of medical device regulation....

Jakub Král
Feb 16, 2024


European AI regulation agreed
On 2 February 2024, the Belgian Presidency announced that the representatives of the EU Member States had already agreed on a final...

Aleš Martinovský
Feb 16, 2024


Here comes 2024: What is on the horizon?
We can infer where the medical device market will go in 2024 from the previous year's news. At least partially. The year 2023 would...

Aleš Martinovský
Jan 8, 2024


2023: What happened in the field of medical devices?
The turn of the year is always accompanied by some kind of taking stock of what has happened in the past year. As far as the medical...

Jakub Král
Jan 8, 2024


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