Module 16 2022

9/2/2022

PSUR embedded in the PMS and CER

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© NAMSA 2021

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PSUR embedded in the PMS and CER The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86. This shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in Annex III. Annex III consists of two sections: o Content of the post-market surveillance plan (article 84); o Reference towards PSUR (article 86) and PMS reports (article 85). Annex VII identifies requirements towards Notified Bodies during QMS audits and TDR assessments. PMS requirements are mentioned. Annex IX identifies QMS requirements for the PMS system

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© NAMSA 2021

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