Webinar | Medical Devices Regulation – Heading in the right direction?
10 September 2018, 11:00 am CET
On the 6 November 2017 HCWH Europe organised a workshop entitled Can the Medical Devices Regulation be an engine for substitution? in the European Parliament. The main objective of this workshop was to examine how provisions included in the Medical Devices Regulation (MDR) can be used to achieve the substitution of medical devices containing harmful chemicals with safer alternatives.
Goals of the webinar
This webinar is a follow-up to that successful workshop and will also cover the provisions laid out in the Health Technology Assessment and how they relate to the MDR.
During the webinar, the European Commission will outline the current regulatory framework applicable to medical devices, including the state of the European Database on Medical Devices (EUDAMED), which is due to become operational in 2019.
Medical device manufacturers will also be represented by a speaker MedTech Europe, who will address the challenges, concerns, and opportunities that the new MDR represents for the industry.
Finally, Zorgnet-Icuro (a HCWH Europe member) will outline the approach it is taking to incorportate environmental sustainability, as well as quality and safety concerns in its procurement of medical devices.
Participants will also have the opportunity to ask questions of the speakers towards the end of the webinar. Please, note that the session will be recorded, and all those registered will receive notification of when the recording is available.
The webinar is aimed at policy makers, healthcare facility managers, and experts interested in practical steps towards the implementation of the MDR in all EU Member States in the healthcare sector and beyond.
Oliver BISAZZA, Director, Regulations & Industrial Policy - MedTech Europe
Oliver Bisazza is based in Brussels, Belgium, where he heads the regulatory affairs team at MedTech Europe: the association representing the medical technology industries in Europe.
In this role, Oliver’s focus is implementation of the EU regulations on medical devices and in vitro diagnostics. He acts as these industries’ main messenger towards the European Commission and Competent Authorities.
Oliver joined MedTech Europe in August 2018 – prior to that, he was Director of Regulatory Policy EMEA at Medtronic.
Tomas DELIMON, Environmental Expert - Envicas (representing Zorgnet Icuro)
Tomas Delimon has been an environmental consultant for more than 15 years and currently works for ENVICAS, a consulting company providing services for more than 20 hospitals. In this capacity, Tomas is an advisor for environmental affairs to ZORGNET-ICURO, a federation representing all of the hospitals (both public and private) in Flanders. He has been appointed as Environmental Coordinator at several hospitals and works on environmental projects in many other healthcare facilities.
Since 2003, Tomas has also been a board member of VMx vzw (the Association of Flemish environmental professionals). As an published journal author, he is an expert in local environmental legislation and frequently lectures on the topic.
Date & Time
10 September 2018, 11:00 am CET