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.
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.
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