Legal Foundation  
  The legal foundation for the evaluation of clinical data is appendix X § 1 of EU guideline 93/42/EEC (MDD) as well as respective national laws.

Regarding Content
According to guideline 93/42/EEC the medical device's suitability to achieve the intended purposes and claims has to be demonstrated in a clinical evaluation; this assessment has to take into account the intended features and risks of the product. Moreover, undesirable side effects and adverse events have to be examined. This examination can either be based on current data from scientific literature, data from market surveillance or on the analysis of documents and of results derived from clinical testing.  
EU Guideline
MEDDEV 2.7.1
The European Commission provides practical guidance on the preparation of a medical evaluation through its guideline MEDDEV 2.7.1. (revision 3 of December 2009). In this, manufacturers and notified bodies are given advice on procedures and methodology helpful for the creation and assessment of a clinical evaluation. Furthermore, the guideline defines applicable criteria for this kind of evaluation.

The latest version of the MEDDEV 2.7.1 guideline can be found at:

The assessment of anticipated risks in relation to benefits for medical devices requires most current medical knowledge as well as technical know-how regarding specific product risks.

Regarding the Author

According to MEDDEV 2.7.1 the clinical evaluation should thus be carried out by a professional and qualified entity, whose judgment is based on present-day's standard of knowledge and whose objectivity is ensured because it is not affiliated with the client.

For a clinical evaluation via the literature route, MEDDEV 2.7.1 indicates the following possible sources:

  • published and/or un-published data regarding market experiences with the medical device in question or with a device for which equivalence can be established
  • guidelines of medical associations
  • information issued by government agencies
  • manufacturer's clinical data, un-published data
For clinical evaluations based on the results of clinical studies, as per MEDDEV 2.7.1 all relevant documents, which are required for conducting a clinical study according to ISO 14155 (clinical investigation of medical devices for human subjects) have to be consulted.