Module 16 2022

9/2/2022

PMS outputs and distributing PSURs in the EU • The MDCG 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.

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

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© NAMSA 2021

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Ramifications of PSURs once available

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© NAMSA 2021

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