Electronic instructions for the use of medical devices in the EU
Electronic instructions for the use of medical devices in the EU

The digitisation of healthcare is progressing across the European Union and one of its concrete manifestations is the possibility of providing electronic instructions for use (eIFU) for medical devices. This replaces traditional printed manuals, simplifies logistics...

Reimbursement for healthcare provided abroad
Reimbursement for healthcare provided abroad

Travelling abroad and need urgent treatment on the spot? Or are you travelling abroad just for medical care? We'll explain how to get reimbursed for healthcare provided abroad. Urgent/emergency healthcare If urgent care is needed while abroad (anywhere, not just in...

MDR for the second time – risk management system
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
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
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 sixth time – Unique Identification System (UDI)
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:...