One of the most important issues that medical device manufacturers, importers, and economic operators have recently been interested in is the future situation of the sector with MDR. The Medical Device Regulation (MDR) (EU 2017/745), published in May 2017, will replace the Medical Devices Directive (MDD) (93/42/EEC) and the Active Implantable Medical Devices Directive (AIMD) (90/385/EEC). MDR, which is used as the abbreviation of the expression Medical Device Regulation, actually brings very important responsibilities for the medical device sector.

Who Should Attend

• Management, Product Managers, and Employees who will transition from MDD to MDR
• Those who want to have basic knowledge about MDR
• Those who want to specialize in MDR
• Those who want to provide consultancy on MDR
• Those who want to become trainers on MDR
• Personnel responsible for MDR
• Quality Assurance and Quality Control Personnel
• Production, Clinical, and R&D Personnel
• Management, Product Managers, and Employees of organizations obliged to comply with MDR

Training Content

• Topics that will help you determine your roadmap and strategy during the transition process
• Issues that you need to change as medical device manufacturers together with MDR
• Definition of Medical Device
• Medical Device Classification
• Risk Management Process
• PMS & PMCF
• The importance of the quality management system in the regulation of medical devices
• Medical Device Safety and Performance Requirements
• Clinical Data Evaluation
• EUDAMED
• Important dates in the transition process
• UDI
• What you need to do to ensure compliance for the transition process to MDR
• What you need to know about products in accordance with MDR (MDR 2017/745/EU) rules
• The new communication to be established with Certification Bodies
• Preparation of technical files and documentation for your Medical Device