About

THE TRAINING COURSE IS SOLD OUT
If you are interested in, do not hesitate to contact us info@lsacademy.com 


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
Arkan Zwick
Info

Arkan Zwick

Corporate Director Regulatory Affairs at Croma Pharma

Arkan has a master’s degree in law and PhD in European law. His role includes regulatory strategy, advice and advocacy for drug, devices, and combinations product projects as well as in house legal advice for contract management and due diligence projects. His responsibility includes global regulatory compliance and regulatory market access in the EU, Americas and Asia-Pacific for devices and combination products in ophthalmology, orthopedic and aesthetic medicine. Arkan is lecturer and trainer at the University of Applied Sciences in Lower Austria and on life cycle conferences and trainings. He is fluent in English, German, French and Turkish.


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.

Ilaria Butta
Ilaria Butta
Events & Training Manager
Printable Version
At the end of the training, you will be able to
Risultato atteso
Understand content of the Medical Devices Regulation and its impact on the labelling
Risultato atteso
How to achieve compliance before the end of transition period
Risultato atteso
Use practical experience from industry perspective and case study
Risultato atteso
Industry expert overview on the new MDR requirements
Risultato atteso
Hands on experience on high risk devices and how the implement compliance in your company
Risultato atteso
Latest news from MDR developments

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>