Online workshop: Classification of medical devices and certification procedures (Regulation (EU) 2017/745)

The extent and complexity of the implementation of the requirements of the new Regulation depends on the type, intended purpose, technology, and other characteristics of the medical device. To avoid problems that may result in the inability to supply devices to the market or to use them, medical device manufacturers need to align their quality management system and the devices with the requirements of the new Regulation.

Aim

Participants will learn about the most important changes to the classification of medical devices brought by the EU MDR 2017/745. 

Lecturer

Uroš Tacar has more than 28 years of experience in medical devices and in the field of development and legislation. He participated in the establishment of the quality system and in ensuring the compliance of active medical devices. At the manufacturer, he performed the duties of development manager and representative of the quality management. Among the most important tasks, he led the production and maintenance of technical folders of medical devices. He is a consultant and works at SIQ as a lecturer and long-term assessor in the field of medical devices.