Custom-made Device (CMD) according to MDR (2017/745)

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 placed on the market. Accordingly, it is crucial to know the different product categories and be aware of their legal requirements. In this article, you will learn about the following 3 types of devices:

  • Custom-made device
  • Adaptable medical device
  • Patient-matched medical device

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The long-term benefits of UDI

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 business actor, you will benefit in the long run once the system is implemented correctly.

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EUROPE IT EUDAMED Excel Submission method workflow

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 fully understand the global Unique Device Identification mechanism, which is shortly explained in this video.

In addition, this video help you to understand how the data transfer to the EUDAMED works and shows you the submission process from the sending of your Excel template to us to the delivery of your data to EUDAMED. This process is also visualized in the following workflow.

Single Registration Number (SRN) assignment delayed

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 informed in a letter to the German medical device associations (AG MPG) that “the SRN will only be allocated by the authorities with some delay after the regulation starts to apply.” Accordingly, the SRN will not be assigned before the MDR’s effective date of May 26, 2021.

Nevertheless, it is advisable to register early with EUDAMED and to apply for a SRN, so that your data can already be checked by the competent national authority and you will receive your SRN smoothly with the start of validity of the regulation.


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