Project period: 2019–2020

During this year’s 2019 EWMA congress in Gothenburg, EWMA organised a dedicated MDR workshop. With the impending introduction of the Medical Device Regulation (MDR - EU 2017/745), EWMA reacted to concerns and discussions with its wound care industry partners, creating an expert platform to discuss the new regulations in depth.

Due to the overwhelming positive feedback on this session, and the observation that such an approach addresses a clear need, EWMA has decided to offer an executive professional MDR course, customised for wound care manufacturers specifically, to be held on 11 February 2020 from 09:00-16:00 in Copenhagen, Denmark (venue TDB).

During this course, under the skillful guidance of renowned regulatory and clinical experts, EWMA will present a platform for Regulatory and Clinical Affairs professionals to get acquainted with, and discuss in depth, the requirements that MDR will present wound care industry professionals with after May 2020.

The full-day course will focus on many wound care specific MDR challenges, ranging from product development, PMS, PMCF, vigilance, to what MDR could mean for wound healing product marketing and your product distribution/distributors.

Join your wound care colleagues and our two experts, Dr. Bernhard Weber and Dr. Edwin den Braber, who will cover the topics below (subject to alteration) - Dr Jan Apelqvist will also be present at the course and present his views on this topic.

• Wound care MDR in real life
  • Reporting obligations and Design History File
  • PMS, PMCF and Risk Management - what it is and what it is not
  • PMS, PMCF and Risk Management - how do they work together?
  
  
• MDR and clinical wound care data
  • Need for sufficient/significant clinical efficiency
  • Showing equivalence
  • Clinical wound care product data and marketing claims; traction or tension?
  
  
• Wound care Post Market Surveillance (PMS): Clinical end points
  • Consensus: What are accepted end points in wound care clinical trials?
  • Do US clinical data/end points work in the EU?
  • Argumentation: pros and cons of used wound care clinical end points - which to use?
  
  
• Wound care Post Market Clinical Follow-up (PMCF)
  • Preparing a PMCF-plan
  • Which product classes have PMCF obligations to start with?
  • PMCF in practice, PMCF reports and updates of clinical evaluation reports
  
  
• Post market Surveillance: Vigilance
  • Reporting requirements of economic operators
  • Trend analysis
  • Corrective actions and liability
  
  
• Status of MDR implementation
  • Details on the Notified Bodies designation process/progress
  • EUDAMED: current status and registration requirements
  • "Hot topics" - the lastest news

Dr. Bernhard Weber is Associate Director of Quality Management & Regulatory Affairs Healthcare products at Diapharm GmbH & Co. KG.

Dr. Bernhard Weber has a degree and doctorate in Food Chemistry. After more than 10 years as head of laboratory in food and pharmaceutical analytics he joined HÄLSA Pharma, a Diapharm daughter company, in 2009. He was the quality management responsible for medical devices, head of product development and regulatory affairs manager for several medical devices until end 2017. Since then he acts as Associate Director at Diapharm and provides consultancy for quality management and regulatory affairs for medical devices, food and cosmetics.  

Dr. Edwin den Braber, EWMA Innovation Committee

Dr. Edwin den Braber received both his training as a Clinical Toxicologist, and his subsequent doctorate in Medicine on biomaterials, implants, regenerative medicine, tissue engineering, and nanotechnology at the Radboud University, the Netherlands, and Clemson University, USA. 

Next to his academic activities, Dr. den Braber worked with pharmaceutical, medical devices, combination products, and ATMPs at GSK, AkzoNobel/Organon, Tyco Healthcare/Covidien, and Wright Medical. Dr. den Braber has 20 years' experience as Medical Director (regional and global) and VP R&D, Clinical Affairs, Medical Affairs, Regulatory Affairs, QA and Compliance.

Dr Jan Apelqvist is former EWMA President and Director of the Diabetic Foot Centre at the University Hospital of Malmö, Sweden

Dr Apelqvist is a leading expert on wound management and has authored a substantial number of scientific papers over the years in this field.

EWMA has worked with Dr. Weber and Dr. den Braber for the past year on creating awareness of MDR for the wound care industry.

For further information and registering for the course, please contact Steffen Kamp at sk@ewma.org. The deadline for signing up is 3 February 2020.

The fee for participating in this full-day course is 1,900 EUR. Attend the dinner in the evening for an additional 150 EUR (optional).