Introduzione

Significant regulatory changes came along with the EU Medical Devices Regulation 2017/745 (MDR), EU Medical Devices (MedDev) guidelines and EU 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, guidelines, and guidance on clinical evaluation. The training further describes how to prepare the new requirements from a clinical perspective, including the MedDev 2.7.4/1 on clinical evaluation and the MedDev 2.12/2 on post-market clinic follow-up, as well as MDCG guidance on clinical evaluation for legacy devices, and claiming of equivalence.

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).

The entire programme will be delivered in 2 modules of 3 hours.

MODULE 1
Part 1: Overview of Medical Devices requirements

  • Why was the MDR needed?
  • News on MedDevs, Standards, MDCG guidance
  • The ISO 14155:2019 revision
  • NB Guidelines on clinical evaluation
  • Impact on product claims and marketing

Part 2: The MDR requirements

  • MDR in a nutshell
  • Clinical evaluation and investigation routes
  • Equivalence approach

Part 3: Get ready to MDR from a clinical perspective

  • Gap analysis
  • Clinical strategy
  • Processes and strategy with Notified Bodies

MODULE 2
Part 4: MEDDEV 2.7/1 rev 4 and MDCG guidance on clinical evaluation

  • Overview and NB key points
  • Good practice for equivalence justification, including MDCG 2020-5
  • Sufficient clinical evidence for legacy devices MDCG 2020-6
  • Risk assessment and clinical

Part 5: MEDDEV 2.12/2 rev 2 on post-market clinical follow-up studies (PMCF)

  • Overview on PMSP, PMSR, PSUR, CER, PMCF
  • When to conduct PMCF
  • PMCF plan and evaluation report templates MDCG 2020-8 and 7
  • Role of the NB

Case studies / Q&A

  • CEO/CTO´s
  • Regulatory Affairs
  • Quality Assurance
  • Clinical Department
  • Marketing or Business Development responsible

Attendees’ experience
Knowledge of the medical device directive MDD 93/42 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
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.

Online training – 2 modules

MODULE 1 | 06 March 2024          9:30 am – 12:30 pm CET
MODULE 2 | 07 March 2024          9:30 am – 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 07 February 2024)

Ordinary€ 875,00*

Freelance – Individual – Academy – Public Administration**€ 445,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Individual – 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.

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 new elements in ISO 14155 and MDCG guidance
Risultato atteso
How to achieve compliance during the transition period
Risultato atteso
Use practical experience from an industry perspective

<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>