Online workshop: Requirements of Regulation (EU) 2017/745 for Importers and Distributors of Medical Devices

The workshop and materials will be in the English language.Regulation (EU) 2017/745 on medical devices (MDR) also sets out obligations for economic operators such as importers and distributors. The new commitments emphasize the importance of the responsibility of economic operators for medical devices in a certain part of the life cycle, such as storage and transport. At the workshop, we will talk about the practical fulfillment of the requirements of Regulation (EU) 2017/745 for importers and distributors.

Purpose

Participants are informed about the most important changes and obligations for importers and distributors of medical devices brought by Regulation (EU) 2017/745.

Content

• Basic overview of MDR requirements for importers and distributors of medical devices (Article 13 and Article 14).
• New requirements for the translation and packaging of medical devices (Article 16).
• Quality management system as a tool to meet certain requirements (register of complaints, sampling, etc.).
• Practical fulfilment of obligations, such as traceability and registration of importers.
• Common errors and identified good practices in the distribution of medical devices.

Lecturer Marjetka Kralj Kunčič PhD is a Doctor of Science in microbiology with more than 17 years of experience in quality management systems. Her previous work with a medical device manufacturer included not only laboratory management and quality control, but also active involvement in the development, production and regulatory compliance of medical devices, as well as quality management system compliance. Currently, she works as an SIQ auditor and a consultant in the field of medical devices and a member of the technical group for the preparation of health protection standards.

Certification procedure

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