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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
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
- 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: How to prepare for MDR audit
- 1st wave audit guidance: main MDR topics check
- 2nd wave audit guidance: what is new compared to MDD
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 and guidance expected in 2020
Recap day two / Q&A
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.
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.
This medical devices regulation (MDR) training will consist of several modules including lectures, cases studies and interactive sessions (Q&A).
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.
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.
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.
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.
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.
Tuesday, September 22, 2020
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
Understand critical points impacting audit preparation and compliance of processes and products