Introduzione
The classification of medical devices in the EU is set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR) and in the recently published MDCG Guidance (MDCG 2021-24).
The classification of a product as device and specific risk class has practical relevance for the market access strategy, the research and development, the conformity assessment procedure and data prerequisites in the pre-clinical, clinical and manufacturing module of the technical dossiers as well as the labelling, post market and traceability requirements.
This course is dedicated to the detailed understanding on the legal basis and guidance of the classification logic, the medical device definition, how to carry out classification, which procedure to follow for classification requests with notified bodies or competent authorities and the practical regulatory relevance of classification on the technical documentation and the conformity assessment process.
The course will give typical examples for each classification rule and will focus on borderline products such as medical device software, substance-based devices, injectable devices and device-drug combinations.
The course will cover the following topics:
- Classification of medical devices in the MDR and MDCG 2021-24. Impact on conformity assessment and data requirements.
- How to conduct classification – a step by step approach. Procedure with notified bodies and Competent authorities.
- Borderline examples, critical points and latest developments.
- Combination products, substance-based devices, software.
The course will be of interest to anyone involved in the classification process of medical devices:
- R&D Department
- Quality Assurance
- Clinical Department
- Regulatory Affairs
- CROs
Participant Experience
Both newcomers and experts
Presentations and examples and Q&A.
Participants are welcome to share specific cases that can be discussed during Q&A.
Docente/i
Arkan Zwick
Mr. Arkan Zwick is Corporate Regulatory Affairs Director at a global pharmaceutical and surgical company active in ophthalmology, orthopedics, and aesthetic dermatology. With over 15 years of regulatory experience, he oversees EU compliance with notified bodies and manages global market authorizations across the Americas and Asia-Pacific. His expertise spans regulatory advocacy for drugs, medical devices, combination products, and cosmetics, as well as legal counsel on contracts, mergers & acquisitions, and intellectual property. Arkan holds a master’s degree in law and a PhD in European Law from the University of Vienna. He lectures in Vienna and speaks regularly at international conferences.
This online training consists of 1 module:
24 March 2022 from 9:00 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 10 March 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.
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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.