Medical device software qualification
Before jumping headfirst into the complexity of the Medical Device Regulation, you must be 100% sure that it is worth it. This assessment can be complex if you sell health-related…
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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…
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…
UDI format for GS1 & HIBC
The format of your UDI codes, Basic UDI-DI and UDI-DI, depends on the selected Issuing Agency. For the two most commonly used Issuing Agencies, GS1 and HIBC, we have summarized…
Summary: Guidance on the Management of Legacy Devices
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…
EUROPE IT EUDAMED Excel Submission method workflow
By using the Europe IT submission method, you can easily submit your UDI data to EUDAMED via Excel. But before starting to consider the data transfer process, make sure you…
UDI EUDAMED FAQ
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…
Single Registration Number (SRN) assignment delayed
Compared to other European countries, many German economic operators have not yet been assigned their Single Registration Number (SRN), and there are reasons for this. The Federal Ministry of Health…