Significant regulatory changes have come along with the EU Medical Devices Regulation 2017/745 (MDR) and MEDDEV evolutions affecting the medical device clinical evaluation. This course gives participants an overview on the requirements for the clinical evaluation of medical devices and the impact of the MDR and guideline documents on clinical activities. Get prepared for the new requirements from a clinical perspective including the MEDDEV 2.7.4/1 on clinical evaluation and the MEDDEV 2.12/2 on post-market clinic follow up!
A clear understanding of the regulatory requirements will give you an important tool to be fully compliant.
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 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 Medical Devices requirements
• MDD vs MDR, what is new?
• Clinical MEDDEVs and Standards
• The reviewed ISO 14155:2019
• NB Guidelines
• Impact on product claims and marketing
Module 2: The MDR requirements
• MDR in a nutshell
• Clinical evaluation and investigation
• Equivalence approach
Module 3: Get ready to MDR from a clinical perspective
• Gap analysis
• Clinical strategy
• Processes and strategy with NBs
Module 4: MEDDEV 2.7/1 rev 4 on clinical evaluation
• Overview and NB key points
• Good practice for equivalence justification
• Risk and clinical assessment
Module 5: MEDDEV 2.12/2 rev 2 on PMS
• PMSP, PMSR, PSUR, CER, PMCF
• When to conduct PMCF
• Role of the NB
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 medical device clinical evaluation
- Understand new elements in ISO 14155
- Understand how to achieve compliance during the transition period
- Take advantage of the practical experience from industry expert
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.