Significant regulatory changes have come along with the EU Medical Devices Regulation 2017/745 (MDR) and evolutions affecting pre-clinical and clinical evaluation of medical devices and notified bodies. Also, due to research and innovation, the amount of Device Drug and Drug Device Combination Products (DDCPs) is growing.
- Gives you an overview of the requirements for DDCPs under the new MDR
- Guides you through the regulatory pathway of combi products
- Gives you a clear understanding of the regulatory requirements for devices containing medicinal substances and devices provided in combination with drug products
- Gives hands-on insight on how to achieve compliance and the requirements for regulatory documentation and CE marking
To whom it may concern
Quality Assurance, Regulatory Affairs, Clinical Operations, Medical Writing, Research & Development, CEO / CTO´s working for medical device manufacturers, pharma and biotech companies, CROs, Research Centres and Universitiesapplied sciences and biotechnology faculties.
Knowledge of the Medical Devices Directive (MDD 93/42) and of the Medical Devices Regulation (MDR) 2017/745 is an advantage. Newcomers are welcome.
Module 1: Definition of combination products (DDCPs)
• Drug-Device Combinations (integral or non-integral)
• Device-Drug combinations
• Background and Guidance
Module 2: Understanding the medical devices regulation (MDR)
• Directives, regulation, Guidance and standards applicable for medical devices
• Notified body and CE marking principles
• Medical Devices Regulation (MDR) 2017/745 in a nutshell
• Labelling requirements for medical devices
Module 3: Process for conformity assessment
• Process for CE marking according to risk class
• Process for Drug-Device combination products
Module 4: Technical documentation for DDCPs
• What is required
• Structure of the dossier and the drug part
• Pre-clinical testing, Usability
• Clinical evaluation
Module 5: Quality requirements for drug-device combinations
• Legal basis
• Module 1,3.2
• Life cycle and post-market requirements
Case studies / Q&A
Type of training
5 training Modules
At the end of the training, you will be able to:
- Understand the content of the MDR and its impact on the conformity assessment of devices.
- Understand the requirements for combination products and the registration process to obtain CE marking.
- Gain practical experience on the life cycle of products.
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.