- Duration: 30 min
- Location: Dublin
- Language: English
The EU MDR defines Post-Market Clinical Follow-up (PMCF) as a continuous process that updates the clinical evaluation referred to in Article 61 Clinical Evaluation and Part A of Annex XIV Part A Clinical Evaluation. PMCF is a proactive collection and evaluation of real-world clinical data, with the aim of confirming the safety and performance throughout the expected lifetime of the device.
There 4 main methods of PMCF activity in order to collect the data: traditional clinical studies, registries, Observational data collection, surveys.
Depending on the medical device, each method has its own considerations on data quality and PMCF design as well as risks and benefits. The Webinar below outlines the team effort, and also the pros and cons of using surveys for PMCF, how to distinguish between Marketing Surveys, Clinical Surveys and Subject Surveys, and what needs to be considered from an Investigator’s perspective. This case study will be explained from our senior clinical project manager and ophthalmologist.
Learning Objectives
Interdisciplinary team set-up
- Survey based on Classification of Device:
- Difference between Marketing Surveys, Clinical Surveys, Subject Surveys
- Retro- or prospective Data collection,
- Question of validation of survey
- Investigator’s perspective
Presenters:
MARKO LUKIC, PHD, FEBO, FASRS
Scientific Board Member, Referent Ophthalmology at ECLEVAR MEDTECH
Dr. Marko Lukic, Ph.D. FEBO FASRS is a consultant ophthalmologist specializing in retina and uveitis. He is affiliated with Moorfields Eye Hospital NHS Foundation Trust, where he serves as a consultant ophthalmologist in medical retina digital imaging clinics. Dr. Lukic completed two fellowships at Moorfields Eye Hospital: in 2016 Clinical Medical Retina Fellowship and the 2017 Clinical Research in Retina Fellowship. During his clinical research fellowship, dr Lukic participated as an investigator in more than 15 clinical trials. Dr. Lukic passed the ICO subspecialist exam in the retina in October 2020 and finished his Ph.D. in November 2021 at the Medical School of the University of Split, Croatia.
Dr. Lukic has been designated as a Fellow of the American Society of Retina Specialists since May 2022.
Dr. Lukic’s research interest is real-life data in diabetic macular oedema and wet age-related macular degeneration. His continuous research work resulted in manuscripts published in highly ranked journals like Nature Medicine, AJO, Retina, EJO, etc. He serves as a reviewer in highly rated ophthalmology journals. Dr. Lukic has been part of the team of experts who participated in a collaborative project between Moorfields Eye Hospital and Google’s Deep Mind to develop an artificial intelligence system to recognise various retinal conditions based on deep learning protocol. Dr. Lukic lectures ophthalmology at the Medical School of Zagreb and serves as a medical retina tutor to optometrists at the University College of London, UK.
Dr. Lukic is the owner and director of the European Medical Consultants, one of the leading European companies specializing in teleophthalmology. Dr. Lukic sits on the advisory board of Eclevar and serves as an external expert for Specsavers Nordic.
