Introduzione
Labelling Requirements for Medical Devices
The EU Medical Devices Regulation (MDR) 2017/745, together with evolving standards and guidance, introduces significant changes affecting the labelling and accompanying information of medical devices. These updates directly impact manufacturers’ regulatory strategies and product compliance activities.
This online training course provides participants with a clear overview of:
- The regulatory requirements for medical device labelling under MDR.
- The influence of guideline documents on labelling activities.
- Practical preparation steps for achieving compliance from a regulatory labelling perspective.
- Latest development on eIFU regulations.
- Case study discussions to connect requirements with real-world applications.
By the end of the course, participants will gain a solid understanding of labelling, instructions for use (IFU) and technical description requirements under MDR and learn how to implement hands-on strategies for compliance.
The participants will be familiar with the new symbols of ISO 15223 and the latest version of ISO 20417, including their correlation with MDR and understand the latest developments in electronic Instructions for Use (e-IFU) regulations and impact of the EU Packaging and Packaging Waste Regulation (PPWR).
This training is designed to equip development, regulatory, quality, and labelling professionals with the knowledge and tools needed to ensure compliance and streamline labelling processes in today’s evolving MedTech landscape.
Programme
The training will be delivered in 2 parts, combining regulatory insights, practical guidance, and interactive discussion.
Part 1
Overview of Labelling Requirements
- MDD vs MDR – what has changed?
- Labelling standards and guidelines
- European and national laws
- Latest developments in electronic Instructions for Use (eIFU) and PPWR
The MDR Requirements
- MDR and the transition in a nutshell
- What is new for labelling?
- Risks of mislabelling
- Notified Body expectations during audits
Part 2
Preparing for MDR from a Labelling Perspective
- General requirements (Annex I MDR)
- Instructions for Use (IFU)
- Label and sterile barrier considerations
- UDI implementation & EUDAMED
Symbols in Labelling
- Benefits of using symbols
- Symbols developed under MDR
- National language requirements overview
Case Study – System and Procedure Pack
- Impact on UDI
- Instructions for Use
- Box information
- Practical steps for implementation of eIFU
Wrap-up
- Summary and key recommendations
- Knowledge check (quiz)
- Deveopment Department
- Regulatory Affairs
- Labelling Department
- Quality Assurance
- Clinical Department
- Marketing or Business responsible
Participant experience
Knowledge of the medical device directive MDD 93/42 respectively MDR 2017/745 is an advantage. Newcomers are welcome.
This training combines knowledge transfer with practical application to ensure participants gain both regulatory understanding and hands-on experience.
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 20 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 at University of Applied Sciences (IMC Krems) and speaks regularly at international conferences.
Online Training – 2 modules
MODULE 1 | 03 March 2027 from 2:30 to 5:30 pm CET
MODULE 2 | 04 March 2027 from 2:30 to 5:30 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: € 690,00* (until 10 February 2027)
Ordinary: € 885,00*
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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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.