The EU Medical Devices Regulation 2017/745 (MDR) has brought significant regulatory challenges. These standards also affect the essential requirements for Instructions for Use and Labelling. This course gives you an overview on the requirements for the information accompanying medical devices, necessary to identify the device itself and the manufacturer, together with all relevant safety and performance information for end users or other persons.
A hands-on insight on how to achieve MDR compliance in terms of Instructions for Use and medical device Labelling requirements!
To whom it may concern
Quality Assurance, Regulatory Affairs, Clinical Operations, Labelling Department, Medical Writing, Research & Development, CEO / CTO´s working for medical device manufacturers, pharma and biotech companies, CROs, Research Centres and Universities applied sciences and biotechnology faculties.
Knowledge of the medical device directive MDD 93/42 is an advantage. Newcomers are welcome.
Module 1: Overview on Labelling requirements
• MDD vs 2017/745 MDR, what is new?
• Medical device Labelling Standards and Guidelines
• National laws
Module 2: The MDR essential requirements
• 2017/745 MDR and transition period in a nutshell
• What is new for Labelling?
• Risks of mislabelling
Module 3: Get ready to MDR from a Labelling perspective
• General requirements – 2017/745 MDR Annex
• Instructions for use (IFU)
• Sterile barrier
• UDI label & EUDAMED
Module 4: Symbols to be used in Labelling
• New symbols state of play
• Symbols to be developed under the MDR
• Next steps
Module 5: Implantable devices and hazardous substances
• Implant cards
• Hazardous substances Labelling
Summary and Recommendations / Q&A
Type of Training
5 training Modules
At the end of the training, you will be able to:
- Understand content of the new Medical Devices Regulation (MDR) and its impact on Instructions for Use and medical device Labelling
- How to achieve compliance before the end of the MDR transition period
- Use practical experience from an industry perspective
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharmaceutical, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthal mology, orthopedic and aesthetic dermatology. With more than eleven 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. He is a lecturer at the University of Applied Sciences in Vienna and speaker on life cycle conferences. He is fluent in English, German and French.