Clinical evaluation of medical devices plays a key role in a thorough CE-documentation. It becomes important already in product registration and market entry as well as in later stages of medical-device market monitoring.
According to Medical Device Directive 93/42/EEC and, respectively, in the German Medical Devices Act (Medizinproduktgesetz – MPG), the clinical evaluation is part of the technical documentation and of the conformity assessment. Therefore, it must be submitted at the registration for every medical device, independent of risk category.
A clinical evaluation needs to be conducted on the basis of objective and documented medical criteria and under the direct supervision of a medical expert. Normally, the European MEDDEV 2.7.1 on Clinical Evaluation is used as reference point. It provides method and procedure guidelines for manufacturers and notified bodies. It also defines the criteria applicable for clinical evaluation conduct and assessment.
According to the German Medical Devices Act §19 paragraph 1 and 93/42/EEC directive Attachment X paragraph 1, manufacturers are required to prove suitability for intended usage as well as to perform medical risk assessment for every medical device. This has to take places in the framework of clinical data evaluation. These data have to derive from already existing clinical studies, medical literature, own studies and/or own clinical investigations.
In the clinical evaluation, product and process risks have to be represented in detail with a respective critical expert opinion. This requirement applies to the usage, risks as well as the defined product features.