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Transition Guide to the MDR - new free publication
The Czech Standardization Agency & Porta Medica published "Transition Guide to the MDR" that explains key changes in the MD regulation.
Jakub Král
Oct 7, 2024
EUDR’s Role in Shaping the Czech Timber Act Amendment
Certain entities will be subject to new obligations under Regulation (EU) 2023/1115.
Alžběta Frýdlová
Oct 2, 2024
Equivalence Principle for Simple Medical Devices
The application of the principle of equivalence to the clinical evaluation of medical devices is particularly challenging.
Aleš Martinovský
Oct 1, 2024
AI Act – Significant Change or Substantial Modification?
We know very well what a significant change of (medical) devices is in the scope of the MDR since the publication of MDCG 2020-3 Rev1.
Aleš Martinovský
Sep 20, 2024
Equivalent medical device and biological characteristics
The use of clinical data of a "similar" medical device based on the principle of equivalence is highly problematic.
Aleš Martinovský
Sep 12, 2024
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