Module 16 2024

17/10/2024

The post market surveillance plan

6) Communications processes

Article 87 (Vigilance)

The PMS plan shall cover…

Annex III, 1.1(b), Indent 6 - Methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators, and users;

Vigilance/reporting procedure – describes the processes for vigilance reporting, including trends

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The post market surveillance plan

7) General, PMS, PMS planning and PSUR:

Article 83 (PMS System)

Article 84 (PMS plan)

Article 86 (PSUR)

The PMS plan shall cover…

Annex III, 1.1(b), Indent 7 - Reference to procedures to fulfill the manufacturer's obligations laid down in Articles 83, 84, and 86;

PMS Plan – List all procedures referenced throughout the plan

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