Can a clinical investigation according to EU MDR 2017/745 Article 74 have a confirmatory approach?
A confirmatory approach means that the clinical investigation 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 the EU MDR 2017/745 refers to clinical investigations of medical devices that are
- CE certified,
- used within the intended purpose,
- non-invasive and non-burdensome.
This means that a clinical investigation in accordance with Article 74 of MDR 2017/745 can of course have a confirmatory approach.
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