Module 18 2021

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2/9/2021

PMCF Activities - Surveys

Surveys may be acceptable if there are high quality, but consider these points;

 ‘Patient Reported Outcome Measures’ Essential  Should not be focused on Usability  Clinical Endpoints  Statistically powered  Quantitative assessment of safety and performance  Qualitative assessment when required  Wide Distribution  Anticipated return rate.

Clinical Evidence – MDCG 2020-6 Evidence Source

1 High Quality Clinical Investigations 2 Medium Quality Clinical Investigations 3 High Quality Registry Data 4 Justifiable Studies with some Methodological flaws/ High Quality Surveys 5 Equivalence Data (Reliable/Quantifiable) 6 Evaluation for State of The Art/Similar Device Evidence (WET Article 52) 7 Complaints, Vigilance. 8 Proactive PMS data such as surveys 9 Case Reports/Studies 10 Compliance to Non- Clinical Specifications 11 Animal study data 12 Pre-clinical/Bench Testing/Compliance to Non-Clinical Standards

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