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...
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Aleš Martinovský
Dec 3, 2023
Sterile Barrier System in MDR and IVDR
With the transition from MDD to MDR and IVDD to IVDR, manufacturers of medical devices face a number of challenges. One of the most...
Aleš Martinovský
Sep 17, 2023
Critical Areas for Transition from MDD to MDR (updated)
We have prepared an overview of the areas we consider CRITICAL in preparing for the transition from MDD to MDR. The selection is based on...
Jakub Král
Aug 29, 2023
English commentary on MDR release is planned for autumn, followed by a commentary on IVDR
Porta Medica, in cooperation with the Czech Agency for Standardization, published in 2022 both a book (printed) and an electronic version...
Aleš Martinovský
Aug 20, 2023
New survey on the capacity and experience of notified bodies
On 25 July 2023, the European Commission published a Notified Bodies Survey on certifications and applications (MDR/IVDR). The data...
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