Introduzione
The implant card is one of the new requirements of the European Medical Devices Regulation (MDR) EU 2017/745.
The manufacturers of implantable devices must prepare and provide to the patients an implant card (IC) containing some information on the implanted device. The aim of the IC is to enable the patient to identify the implanted devices and to get access to other information related to it.
Implant cards also enable emergency clinical staff or first responder to be informed about special care/needs for relevant patients in case of emergency situations.
Considering the strict requirements of MDR Article 18, manufacturers are presently facing a great impact from the economic and logistic standpoint. A specific guidance document has been issued on June 2019 by the Medical Device Coordination Group (MDCG): MDCG 2019-8.
This training course aims to equip medical device professionals realise what the MDR Art. 18 impact is and how to implement compliant implant cards accordingly.
Setting the scene
- Requirements of Art 18 MDR for manufacturers
- Updates
- Exceptions
- Purposes of implant cards
- Overview on Implant card requirements in EU, FDA, HC, TGA and NMPA.
Overcoming the fear of implementation
- MDCG guidance
- Team Notified Body Position Paper 20.07.21
- Size and Ease of reading
- Language requirements
- Symbols to be used and standards
Impact and case studies
- Impact of MDR on instructions for use and implant card requirements.
- Labelling example implant resorbable.
- How to implement step by step approach to comply with MDR requirements.
Conclusion & wrapping up
The course will be of interest to anyone involved with the implant card process and who contributes to it:
- Clinical Department
- Regulatory Affairs
- Marketing staff
- CROs
- Medical Writers
Experts and managers from Regulatory, Quality, Labelling, Project managers.
Participant experience
No specific experience necessary. Awareness of the MDR 2017/745 would be useful.
Lecture, Q&A, Case studies. Participants are invited to share their views and project examples.
Docente/i
Arkan Zwick
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharma, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than sixteen 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.
This online training consists of 1 module:
11 November 2022 from 9:30 am to 1:30 pm CET
Some days before the online training 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.
Early Bird: € 465,00* (until 28 October 2022)
Ordinary: € 595,00*
Freelance – Academy – Public Administration**: € 370,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
