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ONLINE TRAINING: The Medical Device Clinical Evaluation
Understanding the clinical evaluation requirements for the MedTech industry in the context of MDR 2017/745
Significant regulatory changes are coming along with the EU Medical Devices Regulation 2017/745 (MDR), MEDDEV and MDCG (Medical Device Coordination Group) guidance evolutions affect the clinical evaluation of medical devices.
This online course gives participants an overview on the requirements for the clinical evaluation of medical devices and the impact of the MDR and guideline documents on clinical evaluation of medical devices. The course 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 and MDCG Guidance on clinical evaluation for legacy devices, equivalence, sufficient clinical data.
The training will allow participants to obtain a clear understanding of the regulatory requirements and will give hands-on insight on how to achieve compliance with respect to the changing environment and new documents to be created such as the summary of safety and clinical performance (SSCP) and periodic safety update reports (PSUR).
The entire program is distributed in 2 modules, 3 hours each
Day 1 | 9:30 am to 12:30 pm CEST
Part 1: Overview on Medical Devices requirements
- MDD vs MDR, what is new?
- Clinical MEDDEVs, Standards, MDCG guidance
- The ISO 14155:2019 revision
- NB Guidelines
- Impact on product claims and marketing
Part 2: The MDR requirements
- MDR in a nutshell
- Clinical evaluation and investigation
- Equivalence approach
Part 3: Get ready to MDR from a clinical perspective
- Gap analysis
- Clinical strategy
- Processes and strategy with NBs
Day 2 | 2:00 pm to 5:00 pm CEST
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
The online training will be in English
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.
CEO/CTO´s, Regulatory Affairs . Quality Assurance . Clinical Department, Marketing or Business Development responsible working for medical device manufacturers, pharma and biotech companies, CROs, Research Centres and Universities applied sciences and biotechnology faculties.
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
Online Training - 3 modules
September 30th, 2020 09:30 am – 12:30 pm CEST
October 1st, 2020 02:00 pm – 05:00 pm CEST
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: € 720,00* (until 9 September 2020)
Ordinary: € 830,00*
Freelance - Academy - Public Administration**: € 430,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Wednesday, September 9, 2020
At the end of the training, you will be able to
Understand content of the new Medical Devices Regulation and its impact on the clinical evaluation of medical devices
Understand new elements in ISO 14155
Understand how to achieve compliance during the transition period
Use practical experience from industry perspective