Module 18 2021

First page Table of contents Previous page 253 Next page Last page

2/9/2021

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

Real World Evidence

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices – August 2017

• FDA guidance to clarify how real-world data is evaluated to determine the types of real-world evidence that can be used in regulatory decision-making for medical devices.

• Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.

• Real-World Evidence (RWE) is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.

Made with FlippingBook flipbook maker