Name: Labelling Requirements for Medical Devices
SKU: 11157
Availability: InStock

About

THE TRAINING COURSE IS SOLD OUT
The registrations for the next ediiton are open: 02 and 03 July 2024
Click here to view all details

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 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.

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

Benefits of symbols
Symbols developed under MDR
Examples and explanations

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

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.

Lecturers

Info

Arkan Zwick

Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharma, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than sixteen years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific.Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.

Useful information
Registration Fee

Online Training – 2 modules

Module 1 | 29 February 2024 from 9:30 am to 12:30 pm CET
Module 2 | 01 March 2024 from 9:30 am to 12:30 pm CET

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 08 February 2024)

Ordinary: € 875,00*

Freelance – Individual – Academy – Public Administration**: € 445,00*

* 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.