MDSAP Audit Approach (MDSAP AU P0002) C3-T14-T15: Evaluate every complaint for adverse event reportability and every quality problem in distributed product for an advisory notice, under documented procedures with recorded rationale for decisions not to report or not to act

What does C3-T14-T15 require?

The organisation must have documented procedures for evaluating complaints against adverse event reporting criteria, with any decision not to report made under the procedure and supported by a documented rationale, and must make effective arrangements for timely evaluation of quality problems in distributed product to decide whether to issue and implement an advisory notice, recording the risk-based rationale for both decisions to issue and decisions not to. The detailed jurisdiction rules are in Chapter 4. Clauses: ISO 13485:2016 4.2.1, 7.2.3, 8.2.3, 8.3.3; TG(MD)R Sch 3 Pt 1 cl 1.4(3)(c); RDC 665/2022 Art 120 VIII, RDC 67/2009, RDC 551/2021; CMDR 59 to 61.1 and 63 to 65.1; MO169 Arts 29, 55-3, 60-3; 21 CFR 803, 806, 820.10(b), 820.35(a).