Medical Devices

Program

Regulation (EU) 2017/745 (MDR)

Workshop and materials will be in English language.

The MDR replaced the Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC). The scope has been extended to include a number of additional devices (devices without an intended medical purpose). The MDR has the force of law across all EU countries, which eliminated different EU countries interpretations and implementations of the requirements.

The scope and complexity of the implementation of the new regulation depends on the type, purpose, technology, and other characteristics of the medical device. In order to avoid issues and to be able to supply products to the market, manufacturers of medical devices must harmonize their operations and devices with the requirements of the Regulation.

Intention

Participants get acquainted with the most important changes and new requirements brought by Regulation (EU) 2017/745.

Content

  • An overview of the basic differences between the old regulation and the MDR
  • MDR requirements
  • Novelties in the field of requirements for manufacturers, importers and distributors of medical devices
  • Novelties in the field of requirements for medical devices
Lecturer

Uroš Tacar has more than 25 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.

The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between.  Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.

Who shall attend this workshop?

  • Manufacturers of medical devices.
  • Representatives or medical software suppliers.
  • Management representatives.
  • Anyone who wants to gain or upgrade their knowledge of MDR.