This website provides you with qualified and up-to-date information on the clinical evaluation of medical devices.
You will not only find information about the legal and medical background, but also guidance on the execution of such a clinical evaluation.
The medical device industry is driven by innovation. This fact gives enterprises with a strong focus on research and development excellent opportunities to secure or increase their market share through innovative products.

Conformity Assessment The clinical evaluation of medical devices plays a vital role when it comes to launching a product. It is part of the technical documentation and the conformity assessment according to the medical device directive 93/42/EEC (MDD) and the respective national laws, e.g. the German Medizinproduktegesetz (MPG). Thus, a clinical evaluation has to be submitted during the official approval process for medical devices, regardless of the product’s risk category.

Clinical Evaluation The clinical evaluation has to comply with objective and well-documented medical criteria, directly employing medical expertise. For this, the recommendations outlined in the European commission’s guideline MEDDEV 2.7.1 apply. This guideline provides manufacturers and Notified Bodies with guidance regarding procedures and methodology as well as with criteria for the execution and assessment of a clinical evaluation.
Klinische-Bewertung.de is an information platform catering to experts interested in current and reliable information in the important field of clinical evaluations.