To put the EU Medical Devices (93/42/EEC and 90/385/EEC) in concrete terms, the EU issues so-called MEDDEV documents. In this context, the document MEDDEV 2.7/1 revision 4 entitled "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC" has been newly published. Comprising 65 pages, the document is very extensive and describes requirements for the clinical evaluations of medical devices in Europe.
The new version (Version 4) clarifies some aspects but has also become tighter compared to the previous seven-year-old version which comprised only 45 pages and was thus slimmer. The fact is that the revision is considerably more comprehensive than the previous version. Moreover, examples and suggestions have been added, which - among other things - is reflected in many appendices. The use of "must", "shall", and "have to" relating to the Directives is very interesting as well as the fact that the term "could" is used for own MEDDEV topics in the document (not based on the Directives).
In vitro diagnostic devices are expressly excluded from the scope of the document.
For more detailed information please see the MEDDEV Guidelines - Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC.