Custom-made Device (CMD) according to MDR (2017/745)
The variety of medical devices is also expressed in their different forms. These are an important factor influencing the legal status and the way in which the medical device is…
Archives March 2021
UDI Compliance during Brexit
The UK's exit from the European Union has a great impact on many companies and the medical device business. The following article summarizes the upcoming changes and explains what to…
Practices and solutions until EUDAMED deployment
The European Medical Devices Database (EUDAMED) is not expected to be operational and fully functional with all its 6 modules before May 2022. Nevertheless, the effective date of the Medical…
The long-term benefits of UDI
The process of UDI implementation according to EUDAMED and/or FDA requirements is time-consuming and costly. However, there are significant benefits that go far beyond mere compliance. As a manufacturer and/or…