Module 16 2022

9/2/2022

Surveys and Literature Screening – The Popular Choice

Surveys and Literature Screening

• Surveys:

• Robustness

• No clear objectives • Market satisfaction questions • Narrative response rather than quantitative assessment • Lack of granularity • Access to users • Survey overload • Statistical power vs saturation • Dismissing/not addressing negative responses

• Literature Screening: • Meaningful searches • Robust analysis • Incorporation into risk management, clinical evaluation and IFU • Driving PMCF activities

21

Notified Body Feedback

Notified Body Feedback

• Increased focus on PMCF • Linkage/consistency between risk management, clinical evaluation, IFU and PMCF • Not an option to ignore PMCF requirements • Expectations proportionate to device classification • Some pragmatism on expectations

• Not following MDCG guidelines • Variable expectations from NB • Evidence of PMCF action • Detailed justification of PMCF activities • Detailed assessment of MDCG 2020-7 plan • Statistical rationale challenged • Clinician input

22