Introduzione
The 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 as well as labelling requirements. The Regulation also introduces a new responsible person for regulatory compliance (PPRC) for manufacturers and additional duties for importers and distributors. The Regulation further brings new evaluation procedures for high-risk devices and scrutiny of conformity assessments.
This online training gives Industry a detailed understanding of the new requirements and insight into how to prepare the end of the transition period in May 2021. With this course, participants will get a clear picture of the new requirements, understand the transition timelines and insure compliance to the new landscape.
Module 1 | 2:00 PM to 6:00 PM CEST
Understanding the MDR 2017/745
- Overview
- MDR vs. MDD
- Key changes
- Opportunity or threat?
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
Walkthrough the MDR
- Preamble, Chapters, Annexes
- Latest MDR amendments and consolidated text
- MDCG guidance updates
Recap / Q&A
Module 2 | 2:00 PM to 6:00 PM CEST
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 investigation rules
- Device Drug / Drug Device Combinations (DCCP)
Person responsible for regulatory compliance
- Qualification requirements
- Duties
- Organizational impact
Technical Documentation
- Content of Technical Documentation
- General Safety and Performance Requirements (what is new)
- Labelling requirements
Recap / Q&A
Module 3 | 2:00 PM to 6:00 PM CEST
Post market requirements (PMS)
- Overview of post market requirements
- Periodic Safety Update Reports (PSURS)
- Summary of Safety and clinical Performance (SSCP)
- Impact on Distributors and Importers
Latest updates on the MDR
- NB designation process
- EUDAMED
- MDR implementation status rolling plan
Recap / Q&A
QA Managers, Regulatory Affairs Managers, Clinical Trail Managers, R&D Managers, CEO / CTO´s of companies working for medical device manufacturers, pharma and biotech companies, CROs, Research Centres and Universities applied sciences and biotechnology faculties.
Attendees’ experience
Knowledge of the Medical Device Directive MDD 93/42 is necessary.
The training includes knowledge transfers, interactive sessions, case studies and tool kits helpful for MDR implementation.
Docente/i
Arkan Zwick
Mr. Arkan Zwick is Corporate Regulatory Affairs Director at a global pharmaceutical and surgical company active in ophthalmology, orthopedics, and aesthetic dermatology. With over 15 years of regulatory experience, he oversees EU compliance with notified bodies and manages global market authorizations across the Americas and Asia-Pacific. His expertise spans regulatory advocacy for drugs, medical devices, combination products, and cosmetics, as well as legal counsel on contracts, mergers & acquisitions, and intellectual property. Arkan holds a master’s degree in law and a PhD in European Law from the University of Vienna. He lectures in Vienna and speaks regularly at international conferences.
Online Training – 3 modules
October 20th, 2020 2:00 PM – 6:00 PM CEST
October 21st, 2020 2:00 PM – 6:00 PM CEST
October 22nd, 2020 2:00 PM – 6:00 PM CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 1.280,00* (until 29 September 2020)
Ordinary: € 1.390,00*
Freelance – Academy – Public Administration**: € 730,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
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Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.