Medical Devices

Program

Regulation (EU) 2017/745 (MDR)

Workshop and materials will be in English language.

The EU legislation (MDR) in the field of medical devices stipulate that manufacturers of medical devices must label their products with CE markings before launching them on the EU market. In this way, the manufacturers state that the medical device complies with the EU regulation in the field of medical devices and guarantee a safe and professional medical device.

Intention

At the workshop, you will learn about the regulatory requirements and can find out whether your products comply with the requirements of the EU regulations for medical devices.

Content

  • Structure
  • MDR requirements
  • Requirements for manufacturers, importers and distributors of medical devices
  • MDR classification – Annex VIII
  • Compliance assessement procedures – Annexes IX – XI
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.

Certification procedure

Main steps in the process of obtaining the CE mark and more about certification procedure according to Regulation (EU) 2017/745 and ISO 13485 you can find HERE.

 

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.