The European Medical Device New Regulation 2017/745

This 11-part course covers all aspects of the EU MDR 2017/745 in a comprehensive manner, providing practical guidance and identifying major differences with the current MDD/AIMD on the following topics:

• Basics and background of EU medical device regulations, including roles and responsibilities of key players (such as notified bodies and competent authorities)
• Structure of the EU MDR and other related regulations
• Definition and classification of medical devices (MEDDEV 2.4/1 Rev 9)
• Conformity assessment procedures and routes
• Quality system requirements
• General safety and performance requirements in Annex I and the use of harmonized standards
• Clinical evaluations, including references to MEDDEV 2.7.1/Rev 4 and clinical investigations
• Technical file and design dossier requirements
• Medical device vigilance
• Designation and oversight of notified bodies by the Medical Device Coordination Group
• UDI-DI requirements in Annex VI (to be released in Q1 2020)