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
Info

Arkan Zwick

Corporate Director Regulatory Affairs at Croma Pharma

Arkan has a master’s degree in law and PhD in European law. His role includes regulatory strategy, advice and advocacy for drug, devices, and combinations product projects as well as in house legal advice for contract management and due diligence projects. His responsibility includes global regulatory compliance and regulatory market access in the EU, Americas and Asia-Pacific for devices and combination products in ophthalmology, orthopedic and aesthetic medicine. Arkan is lecturer and trainer at the University of Applied Sciences in Lower Austria and on life cycle conferences and trainings. He is fluent in English, German, French and Turkish.

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.

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Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand the content of the new Medical Devices Regulation
Risultato atteso
Understand the impact on your organization and products
Risultato atteso
Use tools for the implementation of MDR in your company
<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>