The European Union (EU) requires manufacturers to conduct an evaluation of clinical data in connection with all medical device conformity assessments. These requirements are detailed in EU Directive 93/42/EEC as well as the latest revisions of EU Directives applicable to medical devices.
The clinical evaluation requires the manufacturer to take the following steps:
The clinical evaluation report must include all clinical evidence required to support medical device conformity assessments in the EU. Manufacturers of approved medical devices must also regularly update the clinical evaluation report in a pre-defined Modus to include data from actual post-approval experience of the device such as Post Market Vigilance Data.
TÜV SÜD Product Service can conduct voluntary pre-assessments of manufacturers clinical evaluation reports. In addition, TÜV SÜD Product Service has a global staff of medical device experts, with over 400 international specialists located in major markets around the world. These specialists are supported by the in-house Clinical Centre of Excellence and the scientific advisory board that is under the standard TÜV SÜD confidentiality agreement. This board comprises well-recognised European scientists and physicians from the leading universities and healthcare centres.
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