The recently published EU Regulation on Medical Devices 2017/745 (MDR) changes significantly the landscape for the medical device industry. Beyond the familiar framework of the Medical Devices Directive 93/42 based on general requirements for safety and performance, harmonized standards, risk classification, the new Regulation introduce novel requirements in key areas such as stronger Notified Body Oversight, improved General Safety and Performance Requirements, Publicity of data, Clinical Requirements and Post Market Surveillance. The Regulation also introduces a new responsible person for regulatory compliance for manufacturers and additional duties for importers and distributors. The Regulation also brings new evaluation procedures for high-risk devices and scrutiny of conformity assessments.
For the industry, it is just the right moment to get a detailed understanding of the new requirements and understand how to prepare for the end of the transition period in May 2020.
The Seminar allows participants to get a clear picture of the new requirements, understand the transition timelines and insure compliance to the new landscape. The Seminar includes knowledge transfers, interactive sessions, case studies and tool kits helpful for MDR implementation.
To whom it may concern
This course is addressed to anyone who deal with Medical Device and act as:
• QA Manager
• Regulatory Affairs Manager
• Clinical Trail Manager
• R&D Manager
• CEO / CTO
Knowledge of the medical device directive MDD 93/42 is necessary.
Day 1 | 09:30 am to 17:00 pm
Module 1: Understanding the MDR 2017/745
- MDR vs. MDD
- Key changes
- Opportunity or threat?
Module 2: Transition Period and Notified Bodies
- Transition for manufactures and industry
- Transition period for notified bodies
- Current state of designation procedure for notified bodies
- Notified body selection considerations
Module 3: Walkthrough the MDR
- Implementation regulations
Module 4: Classification and conformity assessment
- Classification rules and conformity assessment procedures
- Clinical evaluation consultation of certain class III and IIb devices and scrutiny
- Clinical evaluation and clinical investigation rules
Recap day one / Q&A
Day 2 | 09:00 am to 17:00 pm
Module 1: Person responsible for regulatory compliance
- Qualification requirements
- Organizational impact
Module 2: Technical Documentation case study
- Content of Technical Documentation
- General Safety and Performance Requirements
- Tool box project management
- Tool box technical documentation impact
Module 3: Post market requirements for manufacturers
- Overview of post market requirements
- Periodic Safety Update Reports PSURS
- Summary of Safety and clinical Performance SSCP
Recap day two / Q&A
Type of Training
The Seminar will consist in several modules including lectures, cases studies and interactive sessions (Q&A).
At the end of the training, you will be able to:
- understand content of the new Medical Devices Regulation
- understand the impact on your organization during and after transition
- use a tool boxes for the implementation of MDR in your company
Mr. Arkan Zwick is 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 ten years, regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device 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 graduate master 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 speaker on life cycle conferences. He is fluent speaker in English, German and French.