MDR for the first time – three more letters that should scare you?
The print version of Medical Tribune published our first article focusing on the MDR, the new EU Medical Device Regulation, which will come into force on 26 May 2020. The full article is available here:...
MDR for the second time – risk management system
Our next article on MDR, this time in relation to the risk management system that every manufacturer is obliged to have under the new regulation. Read more here: https://www.tribune.cz/clanek/44589-mdr-podruhe-system-pro-rizeni-rizik
MDR for the third time – clinical trials
In the printed version of Medical Tribune, our third article focused on the MDR, the new EU Medical Device Regulation, which will come into force on 26 May 2020, was published.This time, we focus on some aspects of clinical trials, especially in relation to devices...
MDR for the fourth time – technical documentation
In our fourth article, we will focus on the technical documentation that manufacturers of medical devices are obliged to prepare and keep up-to-date for their products according to the new regulation. The full article is available here:...
MDR for the fifth time – quality management system
You can read our new article on MDR in the September issue of Medical Tribune here: https://www.tribune.cz/clanek/44883-mdr-popate-system-rizeni-kvality
MDR for the sixth time – Unique Identification System (UDI)
Issues relating to the unique device identification (UDI) system contained in Article 27 of the MDR. This is a tool aimed at enabling the identification and traceability of, in particular, mass-produced medical devices. Read more here:...
MDR Seventh – General safety and efficiency requirements
Seventh article on MDR issues, this time focusing on general requirements for the safety and efficacy of medical devices: https://www.tribune.cz/clanek/45212-mdr-posedme-obecne-pozadavky-na-bezpecnost-a-ucinnost
Effectiveness of MDR postponed for one year
On 24.4.2020, Regulation (EU) 2020/561 of the European Parliament and of the Council of 23.4.2020 was published in the Official Journal, which postponed the entry into force of the MDR (Medical Devices Regulation (EU) 745/2020 for one year to 26.5.2021. In practice,...
Fines for health insurers for errors in the procurement procedure for the purchase of vaccines
https://www.uohs.cz/cs/verejne-zakazky/aktuality-z-verejnych-zakazek/2585-zdravotni-pojistovny-porusily-pri-nakupu-ockovacich-latek-pravidla-verejnych-zakazek.html