Module 16 2024

17/10/2024

PMS reporting

© NAMSA 2023 | 57

57

PMS reporting

• Class I, Im, Is, and Ir

Article 85 - Post-market surveillance report

• Class IIa, IIb, III

Article 86 – Periodic safety update report (per MDCG 2022-21)

Reports must - summarise the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post- market surveillance plan….together with a rationale and description of any preventative and corrective actions taken.

© NAMSA 2023 | 58

58

29