Module 16 2022

9/2/2022

PMS outputs and distributing PSURs in the EU • EUDAMED situation? EC statement October 2019: “The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022. The date of application of the MDR remains May 2020.”

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PMS outputs and distributing PSURs in the EU • MDCG 2021-1 Rev.1: Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional was published in May 2021. The scope of the MDCG document is to provide guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonized administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional. Page 23 of the MDCG document covers the alternative process for PSUR’s for Class III and implantable devices.

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