FAQ Friday with Stefan Menzl: answers to your questions about changes to MDD devices

Stefan Menzl "What inspires me everyday is how applied medical technology makes a positive change to patients lives. Qserve offers the unique combination of a global reach, high level of expertise and staff with field experience and former positions at manufacturers, Notified Bodies, US FDA or China CFDA."

We are very excited about the many FAQ Friday questions we have received in the past months. Hopefully, you appreciate our expert vlogs and the answers were helpful.

🔎 In this weeks vlog, Stefan Menzl answers questions regarding changes to MDD Devices.

The question of this week stated as following:

As we move into the grace period of the EU MDR, if there’s a change to the MDD certified device, and need to update technical files and GSPR checklist, even when deemed non-significant, we’d usually re-sign off the DoC. Though with the repeal of the MDD on 26th may 2021, if the change is not deemed significant to trigger an MDR compliance (Art. 120.3), we could still move forward and implement it. The question then comes, can we still re-sign off the MDD DoC? It seems strange since MDD is superseded by MDR; how would you recommend to fully document this? Only update the technical file and GSPR checklist and keep it on the respective revision histories?


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