Discover the course

The EU Medical Devices Regulation 2017/745

Understanding the Medical Devices Regulation and its impact on Industry
Latest updates after the MDR 2017/745 date of application

Date

20 - 21 October 2020

Location

Vienna

Language

English

The EU Medical Devices Regulation 2017/745

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 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 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.


DAY 1: 10:00 - 18:00
Module 1: Understanding the Medical devices regulation 2017/745

  • Overview 
  • 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

  • Preamble
  • Chapters
  • Annexes
  • 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
  • Duties
  • Organizational impact


Module 2: Technical Documentation case study

  • Content of Technical Documentation
  • General Safety and Performance Requirements
  • Tool kit project management & technical dossier
  • Labelling 


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
  • EUDAMED
  • Implementation status

Recap day two / Q&A


Arkan Zwick
Arkan Zwick Corporate Regulatory Affairs Director of 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. 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.

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.

Attendees’ experience

Knowledge of the medical device directive MDD 93/42 is needed.

This medical devices regulation (MDR) training will consist of several modules including lectures, cases studies and interactive sessions (Q&A).

The training course will take place in Vienna


Upon Arrival
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.

Refreshments
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.

Limited number of participants to encourage networking and discussion.



Training Room

All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.



Teaching materials

All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.

Fee includes
Tuition, teaching materials, lunch and coffee breaks, organizational office assistance, attendance certificate. 

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.
Brochure
Certificate of attendance

Early Bird: € 1.570,00* (until 22 September 2020)

Ordinary: € 1.780,00*

Freelance - Academy - Public Administration**: € 890,00*


*
for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.

Register now

Course Price

1780.00 €

Early Bird

Tuesday, September 22, 2020

1570.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

2 days

Course Type

Limited number of partecipants

You will receive

Certificate of attendance

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

  • Industry expert overview on the new medical devices regulation (MDR) requirements

  • Hands on experience on high risk devices and how to implement the project in your company

  • Latest news from notified bodies designation, implementation regulations, and PSURS, SSCP, MIR templates

Participants' Feedbacks

In each topic there was some relevance to my daily work

Availability and competence of the lecturer

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

It is not a frontal lesson but an interactive one

I was put at ease during the course and the discussions

no standard workshop which is very stressful so the way that this course was conducted was excellent and the first one for me were I was so relaxed… thank you for that feeling!

Comparison with problems faced in other working realities

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The EU Medical Devices Regulation 2017/745

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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

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.
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VAT: IT03633040161
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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 (70% refund of the registration fee) will only be given if cancellation is received at least one week before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed 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. 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, or hostilities.

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