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
Prices and reimbursement of medical devices in a new guise
You can read our new article in the July issue of the Medical Tribune here: https://www.tribune.cz/clanek/44821-ceny-a-uhrady-zdravotnickych-prostredku-v-novem-havu
Proposed regulation of advertising of medical devices
Discussion of the amendment to the Medical Devices Act, which will come into force in May 2020, and related changes concerning the regulation of advertising of medical devices. Full article available here:...
Reimbursement of voucher medical devices from public health insurance in a new guise
This article introduces readers to the changes brought about by the new medical device voucher reimbursement system. It concerns mainly the system of inclusion of reimbursement groups in the Public Health Insurance Act and the transfer of the agenda to the competence...