06/2021
Business & Life

From shortcut to implementation - you never stop learning!

TRACOE has done its MDR homework

"It is of great advantage to make the mistakes from which one can learn quite early." (W. Churchill)

True to Churchill's motto, TRACOE started early and intensively with the preparations for the MDR transition. For example, we registered with EUDAMED as a manufacturer. Despite challenges from COVID-19, TRACOE has already mastered the MDR certification audit in 2020, in addition to three surveillance audits (13485:2016, MDD and MDSAP). By the way, we were the first company for our Notified Body to be certified on site.

As a result of the MDR, all processes relating to medical technology products are now more extensive than before, and approval has become much more complex. This has led, for example, to long waiting times for certification appointments. After all, there are now 20 notified bodies in Europe, 6 of them in Germany alone. (1) The bottlenecks at the certification bodies are gradually being reduced but will remain noticeable for a long time. However, the demands on personnel there have also increased enormously. Everyone involved in the process finds themselves facing the challenge of having to learn a lot of new things, and this applies equally to examinees and examiners.

The whole thing is made even more difficult by the fact that some things are still in a state of flux and not all regulations have been formulated so clearly that they are comprehensible to everyone. Christine Köstner, Head of Product Management, puts it this way: "We are learning every day. What is "state of the art" for us today may already be different tomorrow. In connection with the changeover to MDR, one can learn that plans are there to be changed." Despite all this, we feel well prepared and the first technical documentation has already been certified according to MDR. Says Köstner, "For Class I products, we had done our homework and were by and large ready to go on May 26. And we have also made good progress with the Class IIa/b products. So we look forward to the future with a certain amount of composure, knowing full well that there are still some challenges to overcome."

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1 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 (Link from 03.05.2021)