The European Commission issued two new guidance documents on Clinical Investigations. MEDDEV 2.7/4 provides Guidelines on Clinical Investigations: A Guide for Manufacturers and Notified Bodies.
The basis for the guidelines SG5/N3:2010 Clinical Investigations posted on April 26, 2010 (see www.ghtf.org). The MEDDEV guidance is adapted to the requirements in Annex X of the Medical Device Directive (MDD). A manufacturer should conduct Clinical Investigation following the guideline. A clinical investigation, in MEDDEV 2.7/4, is “any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety and/or performance of a medical device.” (SG5/N1:2007)
MEDDEV 2.7/3 Clinical Investigations: Serious Adverse Event Reporting provides information on reporting adverse events occurring in clinical investigations. The website also provides an Excel form for reporting.
You can download these new guidance documents at http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/