The most significant regulatory changes coming along with the EU Medical Devices Regulation 2017/745 (MDR) and MEDDEV evolutions affects the clinical evaluation of medical devices.
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. The course further describes how to prepare 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. 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
- Quality Assurance
- Clinical Department
- Marketing or Business Development responsible
Knowledge of the medical devices 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
- 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
Module 4: MEDDEV 2.7/1 rev 4 on clinical evaluation
- Overview and NB key points
- Good practice for equivalence justification
- Risk assessment and clinical
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
Interactive training with case studies a Q&A sessions
At the end of the training, you will be able to:
- Understand content of the new Medical Devices Regulation and its impact on the clinical evaluation 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 devices 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’s 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.