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 to the new requirements from a regulatory labelling perspective.
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.
DAY 1
Module 1: Overview on labelling requirements
- MDD vs MDR, what is new?
- Labelling Standards and Guidelines
- National laws
Module 2: The MDR requirements
- MDR and transition in a nutshell
- What is new for labelling?
- Risks of mislabelling
DAY 2
Module 3: Get ready to MDR from a labelling perspective
- General requirements Annex I MDR
- Instructions for use (IFU)
- Label
- Sterile barrier
- UDI & EUDAMED
Module 4: Symbols to be used in labelling
- New symbols state of play
- Symbols to be developed under MDR
- Next steps
Module 5: Implant device and hazardous substances
- Implant cards
- Hazardous substances labelling
Summary and Recommendations / Q&A
- Regulatory Affairs
- Labelling Department
- Quality Assurance
- Clinical Department
- Marketing or Business Development responsible
Participant experience
Knowledge of the medical device directive MDD 93/42 is an advantage. Newcomers are welcome.
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
18 November 2021 from 09:30 am to 12:30 pm CET
19 November 2021 from 09:30 am to 12:30 pm CET
After the registration, you will receive all details about the connection.
The course admits maximum 12 attendees.
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: € 660,00* (until 21 October 2021)
Ordinary: € 850,00*
Freelance – Academy – Public Administration**: € 430,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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Versione Stampabile
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.