Introduzione

Clinical regulatory changes came along with the EU Medical Devices Regulation 2017/745 (MDR), EU Medical Devices (MedDev) and Medical Device Coordination Group (MDCG) guidance evolutions affecting the clinical evaluation of medical devices.

This online course gives participants an overview of the requirements for sufficient clinical data for medical devices and the impact of the MDR and guidance on clinical evaluation and claims associated with devices.

The training further describes how to prepare the new requirements from a clinical perspective with a focus on high-risk devices but also exemptions from clinical data for low-risk devices including interactions with notified bodies and guidance on clinical evaluation for legacy devices, claiming of equivalence and requirements for post market clinical follow-up (PMCF).

The training will allow participants to understand the regulatory requirements clearly. It will give hands-on insight into how to achieve compliance with respect to the changing environment and interaction of documents such as the summary of safety and clinical performance (SSCP) and periodic safety update reports (PSUR), labelling and marketing claims.

Module 1 – Understanding the MDR and its impact on clinical evidence.

  • Some clinical questions to warm up.
  • Key changes for industry and differences MDD to MDR.
  • Changes in clinical evaluation and opportunities and risks.
  • Debriefing and Questions.

Module 2 – MDR Transition and system readiness

  • MDR key dates and transition.
  • Expert panels, Common specifications and EUDAMED state of play.
  • Case study for a class III combination product and low risk Art. 61(10).
  • Debriefing and questions.

Module 3 – Conformity assessment and sufficient clinical data

  • Clinical evaluation concept and documents required.
  • Procedures for high-risk devices and combination products.
  • When do I need clinical data?
  • Procedures for detecting and closing gaps.

Module 4 – Equivalence, Post market PMCF and claims

  • Principles of an equivalence approach.
  • What is PMCF and when do I need a PMCF study?
  • Claims.
  • Debriefing and questions.

Case studies / Q&A

  • Management responsible persons (CEO)
  • Regulatory Affairs & Quality Assurance
  • Persons responsible for regulatory compliance (PRRC)
  • Clinical Department
  • Marketing or Business Development responsible

Participant experience
Knowledge of the medical device regulations MDR is an advantage. Newcomers are welcome.

Online training with case study discussion and Q&A sessions.

Docente/i
Arkan Zwick
Info

Arkan Zwick

Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

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.


Online Training – 2 modules

MODULE 1 | 06 March 2025 from 09:30 am to 12:30 pm CET
MODULE 2 | 07 March 2025 from 09:30 am to 12:30 pm CET

After the registration, 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: € 680,00* (until 20 February 2025)

Ordinary: € 875,00*

Freelance – Individual – Academy – Public Administration: € 495,00*

* for Italian companies: +22% VAT

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Ilaria Butta
Ilaria Butta
Events & Training Manager
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand the content of the Medical Devices Regulation 2017/745 and its impact on the clinical evaluation of medical devices.
Risultato atteso
Understand what quality and quantity of clinical data is needed per risk group.
Risultato atteso
How to achieve compliance during the transition period.
Risultato atteso
Use practical experience from an industry perspective in notified body interactions.

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