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ONLINE TRAINING: The EU Regulation 2017/745 on Medical Devices

Understanding the Regulation and its impact on Industry

Date

20-21-22 October 2020

Location

Online

Language

English

ONLINE TRAINING: The EU Regulation 2017/745 on Medical Devices

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

Course Language

The online training will be in English
Arkan Zwick
Arkan Zwick Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

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. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.

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.

Online Interactive Training

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.

Certificate of attendance

Early Bird: € 1.280,00* (until 12 October 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: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Register now

Course Price

1390.00 €

Early Bird

Monday, October 12, 2020

1280.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

3 modules, 4 hours each

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Understand the content of the new Medical Devices Regulation

  • Understand the impact on your organization and products

  • Use tools for the implementation of MDR in your company

Participants' Feedbacks

International and multidisciplinary profile of participants, which enriches the training

Lecturers know what they are talking about and are able to answer the questions. It's clear that they work and have experience in the field

Availability and competence of the lecturer

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ONLINE TRAINING: The EU Regulation 2017/745 on Medical Devices

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161), as the data controller, will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for, for the management of participation in the course, for sending the newsletter, and for dissemination purposes. You can read the complete information, including your rights and how to exercise them, following this link.