About

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.

Lecturers
Arkan Zwick
Info

Arkan Zwick

Corporate Director Regulatory Affairs at Croma Pharma

Arkan has a master’s degree in law and PhD in European law. His role includes regulatory strategy, advice and advocacy for drug, devices, and combinations product projects as well as in house legal advice for contract management and due diligence projects. His responsibility includes global regulatory compliance and regulatory market access in the EU, Americas and Asia-Pacific for devices and combination products in ophthalmology, orthopedic and aesthetic medicine. Arkan is lecturer and trainer at the University of Applied Sciences in Lower Austria and on life cycle conferences and trainings. He is fluent in English, German, French and Turkish.


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.

Printable Version
At the end of the training, you will be able to
Risultato atteso
Properly design an MDR 2017/745 complian implant card
Risultato atteso
Make sure all regulatory content is present in your implant card
Risultato atteso
Overcome the fear of MDR 2017/745 implant card implementation
Risultato atteso
Successfully decide which of your company’s device need an implant card or not

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>