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Labelling Requirements for Medical Devices under the Medical Devices Regulation 2017/745 (MDR)
A one-day training to understand medical device Labelling requirements under the MDR 2017/745
The EU Medical Devices Regulation 2017/745 (MDR) has brought significant regulatory challenges. These standards also affect the essential requirements for Instructions for Use and Labelling. This course gives you an overview on the requirements for the information accompanying medical devices, necessary to identify the device itself and the manufacturer, together with all relevant safety and performance information for end users or other persons.
A hands-on insight on how to achieve MDR compliance in terms of Instructions for Use and medical device Labelling requirements!
Module 1: Overview on Labelling requirements
- MDD vs 2017/745 MDR, what is new?
- Medical device Labelling Standards and Guidelines
- National laws
Module 2: The MDR essential requirements
- 2017/745 MDR and transition period in a nutshell
- What is new for Labelling?
- Risks of mislabelling
Module 3: Get ready to MDR from a Labelling perspective
- General requirements – 2017/745 MDR Annex
- Instructions for use (IFU)
- Sterile barrier
- UDI label & EUDAMED
Module 4: Symbols to be used in Labelling
- New symbols state of play
- Symbols to be developed under the MDR
- Next steps
Module 5: Implantable devices and hazardous substances
- Implant cards
- Hazardous substances Labelling
Summary and Recommendations / 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, Labelling Department, 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 an advantage. Newcomers are welcome.
5 training Modules
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: € 880,00* (until 10 September 2020)
Ordinary: € 990,00*
Freelance - Academy - Public Administration**: € 490,00*
* 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.
Thursday, September 10, 2020
At the end of the training, you will be able to
Understand content of the new Medical Devices Regulation (MDR) and its impact on Instructions for Use and medical device Labelling
How to achieve compliance before the end of the MDR transition period
Use practical experience from an industry perspective