Following the provisions of the current Medical Device Directives (MDD, AIMDD) and the future Medical Device Regulation (MDR), clinical safety and performance of any medical device must be verified and documented through a Clinical Evaluation which provides extensive information from scientific literature, clinical investigations and post-market surveillance data for the subject device and for an “equivalent“ device, if the “literature route“ is being chosen. Therefore, in order to support medical device manufacturers and notified bodies, the European Commission just recently published a completely revised guideline document MEDDEV 2.7/1 which must be followed when preparing a Clinical Evaluation document.
UL hosted a live webinar on December 8, 2016 on the topic “Clinical Evaluation of Medical Devices according to MDD, AIMDD, New MDR and MEDDEV 2.7/1 Rev. 4: 2016. You can access the webinar recording by filling out the form below. The webinar recording will introduce the aforementioned European regulatory requirements, in particular, the detailed provisions of the new MEDDEV 2.7/1 guideline. Furthermore, the speaker provides practical recommendations how to prepare a Clinical Evaluation Plan and a Clinical Evaluation Report. The 90-minute recording includes a 25 minute question and answer period at the end.
Dr. Dieter R. Dannhorn, Senior Medical Device Expert and Management Consultant
Please fill out the form to get a link to the webinar: