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

Read More

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.


1 2 3 4 5