Why take this course?
The EU Medical Devices Regulation 2017/745 (MDR) significantly changes the landscape for the medical device industry. Beyond the familiar framework of the Medical Devices Directive 93/42 (MDD) based on general requirements for safety and performance, harmonized standards, and risk classification, the new Medical Devices Regulation introduces 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, as well as labelling requirements.
The MDR also introduces a new responsible person for manufacturers regulatory compliance, and additional duties for importers and distributors. The Regulation further brings new evaluation procedures for high-risk devices and scrutiny of conformity assessments.
This training will give you a detailed understanding of the new requirements and the transition timelines, an insight on how to prepare the end of the transition period in May 2020, and will also ensure you are able to comply with the new landscape.
The workshop includes knowledge transfer, interactive sessions, case studies and tool kits that will help you in your MDR implementation.
Who should attend?
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 needed.
Day 1: 10:00 – 18:00
Module 1: Understanding the Medical devices regulation 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 Medical devices regulation
– Latest MDR amendments and consolidated text
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
– Device Drug & Drug Device Combination Products (DDCPs)
Recap day one / Q&A
Day 2: 08:30 – 16:00
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 kit project management & technical dossier
Module 3: Post market requirements for manufacturers
– Overview of post market requirements
– Periodic Safety Update Reports PSURS
– Summary of Safety and clinical Performance SSCP
Module 4: Latest updates on the MDR
– NB designation process
– Implementation status
Recap day two / Q&A
Type of training
This medical devices regulation (MDR) training will consist of several modules including lectures, cases studies and interactive sessions (Q&A).
At the end of the training, you will be able to:
- Understand the content of the new Medical Devices Regulation 2017/745 (MDR).
- Understand the impact on your organization and products.
- Use tool kit for the implementation of MDR in your company.
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. 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.