Maximum number of reuses of device
Information on the maximum number of reuses of devices and their implications on UDI for MDR 2017/745 compliance was recently provided by the MDCG in the Guidance on BASIC UDI-DI…
Information on the maximum number of reuses of devices and their implications on UDI for MDR 2017/745 compliance was recently provided by the MDCG in the Guidance on BASIC UDI-DI…
The IVDR provisions must be applied before May 26, 2022 (during the transition period). As obscurity still remains, the Medical Device Coordination Group (MDCG) recently published indications on how to deal…
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…
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…
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 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…
On the 8th February 2021 the European Commission published a Guidance on the Management of the Legacy Devices. It explains in detail how Legacy Devices will be identified and the…
Many economic operators have questions in the course of their UDI implementation, which are also asked by other economic operators. We have summarized and answered the most frequently asked questions…
You may have noticed that the UDI rules are quite complex and involve different actors.If you are in the MedTech industry, it is even more important to be clear about…
The first MedTech manufacturers have already got their SRN. If you want to find out which companies they are, please have a look on the following link: https://ec.europa.eu/tools/eudamed/#/screen/search-eo