New version of MEDDEV 2.7/1 on Clinical Evaluation of Medical Devices

MEDDEV guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on Medical Devices. They are not legally states but they reflect the positions taken by various interested parties (Competent Authorities, Manufacturers and Notified Bodies) in the medical devices sector.

Among the most relevant guidelines, there is the MEDDEV 2.7-1, entitled Clinical Evaluation: a guide for manufacturers and Notified bodies.

The European Working Group on Clinical Investigation and Evaluation has finalized the fourth revision of the guidance 2.7-1 on Clinical Evaluation. The most important differences from the previous version, issued in December 2009, are the details provided around the concept of device equivalence when it is used as a route for Clinical Evaluation.

The last version in fact underlines how Competent Authorities and Notified Bodies request that only truly equivalent devices can be used in the clinical evaluations based on literature route.

http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/en/renditions/pdf