The most significant regulatory changes coming along with the EU Medical Devices Regulation 2017/745 (MDR) and standards evolutions affects the labelling of medical devices. This 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 department labelling perspective.
The training will allow participants to obtain a clear understanding of the regulatory requirements and will give hands on insight on how to achieve compliance.
Who is the course aimed at?
The course will benefit to:
- Regulatory Affairs
- Labelling Department
- Quality Assurance
- Clinical Department
- Marketing or Business Development responsible
Knowledge of the medical device directive MDD 93/42 is an advantage. Newcomers are welcome.
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
Module 3: Get ready to MDR from a labelling perspective
- General requirements Annex I MDR
- Instructions for use (IFU)
- Sterile barrier
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
Type of training
Interactive learning based on: 5 training Modules, Case studies and Q&A
At the end of the training, you will be able to:
- Understand content of the new Medical Devices Regulation and its impact on the labelling of medical devices.
- How to achieve compliance during the transition period.
- Use practical experience from industry perspective.
Mr. Arkan Zwick is Corporate Regulatory Affairs Director of a private global pharmaceutical and surgical company with products in ophthalmology, orthopaedic and aesthetic dermatology.
With more than eleven years, regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device and cosmetic projects as well as in house legal advice for contract management, merger and acquisition and intellectual property. He is responsible for regulatory compliance in the EU working with different notified bodies and for global market authorizations in the Americas and Asia-Pacific. Arkan has a graduate master degree in Law from the University of Vienna and a PhD in European Law. He has been assigned as lecturer at the University of Applied Sciences in Vienna and as speaker on life cycle conferences and trainings. He is fluent speaker in English, German and French.