Module 16 2024

21/10/2024

Surveys and Literature Screening – The Popular Choice

• Surveys:

• Robustness

•

No clear objectives

•

Market satisfaction questions

• Narrative response rather than quantitative assessment

• Location of survey responses (e.g., in EU or ROW)

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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

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Notified Body Feedback

• Increased focus on PMCF

• Linkage/consistency between risk management, clinical evaluation, IFU and PMCF

• Not an option to ignore PMCF requirements

• Even for low-risk devices which have been on the market for a long time expect that general PMCF activities (e.g., literature searches) are conducted)

• Location of Data source (inside EU or ROW), further PMCF activities required if data not from EU?

• 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

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