May a clinical trial according to EU MDR 2017/745 Article 74 have a confirmatory approach?
A confirmatory approach means that the clinical trial serves to confirm or support existing data or findings or to test (a) pre-formulated hypothesis(es). In contrast, an exploratory approach is used to generate fundamentally new information.
Article 74 of EU MDR 2017/745 refers to clinical investigations of medical devices that
- are CE-certified,
- be used within the scope of the intended purpose,
- are non-invasive and non-stressful.
This means that a clinical trial in accordance with Article 74 of MDR 2017/745 can of course have a confirmatory approach.
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