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New MEDDEV Guidelines on Postmarket Clinical Follow-Up Studies

In addition to MEDDEV 2.7.1 rev.3, “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies,” that was published in December 2009, a new document (MEDDEV 2.12-2 rev.2) has been published, which describes the sources of data/documentation used in clinical evaluations and the appraisal and analysis of clinical data for CE-marked commercial medical devices.

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