Module 16 2024

18/10/2024

PMS outputs and distributing PSURs in the EU

There is an MDCG document providing guidance on certain MDR requirements before EUDAMED is functional – MDCG 2021-1 Rev.1 (May. 2021).

Page 23 of this MDCG covers the alternative process for PSUR’s for Class III and implantable devices.

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PMS outputs and distributing PSURs in the EU

MDCG 2021-1 states:

“For class III devices and for classes IIa, and IIb implantable devices, manufacturers should deliver the PSURs to the relevant notified bodies by appropriate means.

Notified bodies should provide the PSURs and corresponding evaluations to the manufacturers and make them available upon request to the competent authority.”

Manufacturers of the relevant devices should contact their Notified Body to establish what “appropriate means”, means in relation to the specific Notified Body.

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