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Online workshop: Ensuring Traceability of Medical Devices with UDI Labelling & Manufacturer’s Obligations in relation to Post-market activities (Regulation (EU) 2017/745)
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| This workshop will present the requirements of the new Regulation (EU) 2017/745 on Medical Devices, focusing on the regulatory requirements for manufacturers and other business entities after placing medical devices on the market. We will discuss all post-market monitoring activities and learn about the requirements for ensuring the traceability of medical devices. The main purpose of the new requirements of the Regulation is to ensure that only safe and effective medical devices are used in the Common European Market and beyond. |
AimParticipants will learn about the most important changes to requirements for traceability and post-market monitoring of medical devices brought by Regulation (EU) 2017/745. |
Content
- Overview of the basic differences between the MDD and the MDR in the area of traceability
- New requirements for medical device manufacturers
- New developments in the area of requirements for medical devices
- Explanation of the regulatory requirements for participating legal entities
- Ensuring the traceability of medical devices and their labelling
- Post-market monitoring and reporting obligations
Target group
- Manufacturers of medical devices.
- Agents/suppliers of medical software.
- Management representatives.
- Anyone wishing to acquire or upgrade their knowledge of the MDR.
Course and materials will be in English language.
| | 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 wor 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. |
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.
Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail: bojan.varga@siq.si
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