Introduzione
The EU Medical Devices Regulation (MDR) 2017/745, along with evolving guidance’s, introduces significant regulatory changes for the clinical evaluation of medical devices. These updates impact both new and legacy devices, making it critical for manufacturers and regulatory professionals to fully understand and prepare for compliance. This online training course provides participants with a comprehensive overview of:
- The requirements for sufficient clinical data to support regulatory submissions and ongoing compliance.
- How MDR and related guidelines affect clinical evaluation and post-market clinical follow-up (PMCF).
- Practical approaches to use non-clinical data, equivalence demonstrations and strategies for generating robust clinical evidence.
This training is designed to empower regulatory, clinical, and quality professionals in the MedTech industry to navigate the evolving regulatory landscape and build a sound, future-proof clinical evidence strategy.
The online course will be divided into 2 X 3.0-hour modules run during a single week.
Module 1
Overview of Medical Devices requirements
- MDD vs MDR – what has changed?
- Updates on standards and guidance documents
- Guidelines on clinical evaluation
- Impact on product claims and marketing
The MDR requirements
- MDR in a nutshell. Where are you in transition?
- Clinical evaluation and investigation routes
- Equivalence approach and Article 61(10) on the use of non-clinical data
- EU vs. FDA requirements – where to go first. Use of MDR CE in global registrations.
Get ready to MDR from a clinical perspective
- Conducting a gap analysis of your data
- Building a clinical strategy and communicating with notified bodies
- Best practices: briefing books as tools for early advice
- How to meet end of transition timeline
Module 2
MDCG guidance on clinical evaluation
- Overview and key points from notified bodies
- Best practice for equivalence justification (MDCG 2020-5)
- Sufficient clinical evidence for legacy devices (MDCG 2020-6)
- Integrating risk assessment into clinical evaluation
Post market clinical follow up studies (PMCF)
- Overview of post-market documentation and their interactions
- When to conduct PMCF studies
- PMCF plan and evaluation report templates (MDCG 2020-7 & 2020-8)
- Role of the notified body
Case studies – Q&A
- CEO/CTO´s
- Regulatory Affairs
- Quality Assurance
- Clinical Department
- Marketing or Business Development responsible
Participant experience
Basic knowledge of the medical device regulation MDR 2017/745is an advantage. Newcomers are welcome.
Online training with case study discussion and Q&A sessions.
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.
Online Training – 2 modules
MODULE 1 | 25 February 2025 from 2:30 pm to 5:30 pm CET
MODULE 2 | 26 February 2025 from 2:30 pm to 5:30 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: € 680,00* (until 4 February 2026)
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.
Newsletter
Ilaria Butta
Events & Training Manager
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.
