Introduzione
Significant regulatory changes come along with the EU Medical Devices Regulation 2017/745 (MDR) and standards evolutions affects the labelling of medical devices.
This online course gives participants an overview on the requirements for medical devices labelling and the impact of the MDR and guideline documents on product labelling activities.
The course further describes how to prepare for the requirements from a regulatory labelling perspective and discuss a case study.
The training will allow participants to obtain a clear understanding of the regulatory labelling requirements and will give hands on insight on how to achieve compliance.
The course will also cover the new symbols of ISO 15223 and the latest 2021 version of ISO 20417 and its correlation to the MDR requirements and latest evolutions on eIFU regulations.
Day 1
Module 1: Overview on labelling requirements
- MDD vs MDR, what is new?
- Labelling Standards and Guidelines
- European and National laws
- Electronic instructions for use (eIFU) latest news
Module 2: The MDR requirements
- MDR and transition in a nutshell
- What is new for labelling?
- Risks of mislabeling
- Notified Body expectations during audits
Day 2
Module 3: Get ready to MDR from a labelling perspective
- General requirements Annex I MDR
- Instructions for use (IFU)
- Label and sterile barier
- UDI management & EUDAMED
Module 4: Symbols to be used in labelling
- Benefits of symbols
- Symbols developed under MDR
- National language requirements overview
Module 5: Case study – System and procedure pack
- Impact on UDI
- Instructions for use
- Box information
Summary and Recommendations / Q&A
Regulatory Affairs
Labelling Department
Quality Assurance
Clinical Department
Marketing or Business Development responsible
The training includes knowledge transfers, interactive sessions, case studies helpful for MDR implementation.
Docente/i
Arkan Zwick
Mr. Arkan Zwick is Corporate Regulatory Affairs Director at a global pharmaceutical and surgical company active in ophthalmology, orthopedics, and aesthetic dermatology. With over 15 years of regulatory experience, he oversees EU compliance with notified bodies and manages global market authorizations across the Americas and Asia-Pacific. His expertise spans regulatory advocacy for drugs, medical devices, combination products, and cosmetics, as well as legal counsel on contracts, mergers & acquisitions, and intellectual property. Arkan holds a master’s degree in law and a PhD in European Law from the University of Vienna. He lectures in Vienna and speaks regularly at international conferences.
Online Training – 2 modules
MODULE 1 | 01 October 2025 from 09:30 am to 12:30 pm CEST
MODULE 2 | 02 October 2025 from 09:30 am to 12:30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 680,00* (until 15 September 2025)
Ordinary: € 875,00*
Freelance – Individual – Academy – Public Administration: € 495,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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Events & Training Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.