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 new requirements from a regulatory labelling perspective.
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.
Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria
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 ophthalmology, 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. 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.
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