Discover the course

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

Date

08 October 2020

Location

Vienna

Language

English

Labelling Requirements for Medical Devices under the Medical Devices Regulation 2017/745 (MDR)

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)
  • Labels
  • 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

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.

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.


Participant experience

Knowledge of the medical device directive MDD 93/42 is an advantage. Newcomers are welcome.

5 training Modules

Case studies

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: € 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.

Register now

Course Price

990.00 €

Early Bird

Thursday, September 10, 2020

880.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

1 day

Course Type

Limited number of partecipants

You will receive

Certificate of attendance

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

Participants' Feedbacks

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

Perfect opportunity to have "hot topics" to discuss outside the"own environnment". Opportunity to have several topics discussing in just one day

The limited number of participants allows a better interaction with the teachers, who can answer all the questions

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Labelling Requirements for Medical Devices under the Medical Devices Regulation 2017/745 (MDR)

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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.
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 (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.

Information collection and use
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) 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 sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers, scientific board, speakers, conferences’ sponsor), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, 
following this link.