id	author	title	date	pages	extension	mime	words	sentence	flesch	summary	cache	txt
amwa-216	Nguyen, Thi	Resources for Researching Medical Devices Using Publicly Available Databases: Open Session Report	2022	2	.pdf	application/pdf	1367	54	33	The first relevant guidance is MEDDEV 2.7/1 Rev. 4 (June 2016), which offers manufacturers and notified bodies guidance on clinical evaluation under direc- tives 93/42/EEC and 90/385/EEC. AMWAJournal.org 59Researching Medical Devices Using Publicly Available Databases Resources for Researching Medical Devices Using Publicly Available Databases Speaker Sara VanWyk, MPH, CCRP, RAC, MWC / Clinical Evaluation Reporting, LLC, St. Petersburg, FL By Thi Nguyen, BS The clinical evaluation of medical devices marketed in the European Union (EU) is influenced by guidance from the Medical Device Coordination Group (MDCG) and still-rel- evant sections of MEDDEV 2.7/1 Rev 4 (Medical Devices Document 2.7/1 Revision 4; June 2016).	cache/amwa-216.pdf	txt/amwa-216.txt