EUCOMED: The Appropriateness of Evidence and the Learning Curves for Medical Devices in Europe
Supplement Paper to the Eucomed Position paper on Health Technology Assessment (Siebert et al, 2002) Aiming to Clarify two Important Topics that were already partly Addressed in the First Paper: the Appropriateness of Evidence and the Learning Curves for Medical Devices in Europe. Eucomed supports the need for robust evidence to substantiate the claims on effectiveness of a medical device. The level of evidence should provide decision-makers with sufficient confidence of relevance and reliability of findings. The latter can clearly be associated with experimental methods but can, in certain cases (discussed below), also be achieved through well-designed observational studies. In these cases, observational data should be considered as a valid alternative to experimental methods.