About

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.

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:

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.

Printable Version
At the end of the training, you will be able to
Risultato atteso
Understand how to classify your medical device
Risultato atteso
Understand the criticality of intended use and medical purpose wording
Risultato atteso
Anticipate the impact of classification on your technical dossier and conformity assessment process
Risultato atteso
Understand the latest developments in EU MDR

<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>