Hear Veeva MedTech, Abbott Rapid Diagnostics, Team-NB, TÜV SÜD share perspectives and best practice on performing remote audits under EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The medical device and diagnostics industry is facing the most challenging time in its history. While the industry has to put significant measures in place to respond to COVID-19, from submitting urgent filings, supply chain interruptions, and adapting to a new way of collaborating, regulatory teams still have to keep pace and plan for changes like European MDR and IVDR.
In 2020, the MDCG allowed notified bodies to perform remote audits under MDD and IVDD in specific cases when the inability of notified bodies to conduct on-site audits could raise the risk of shortages of vital devices.
With the rapidly approaching DoA of both the MDR/IVDR and the continued presence of the Covid-19 pandemic, the European Commission acknowledged the exceptional circumstances that would justify "extraordinary measures" like virtual audits while the pandemic is still upon us.
However, a harmonized approach by all the EU member states and notified bodies is not yet in place.
In this session, both representatives from the industry and notified bodies share their perspectives on how virtual audits can be executed in a safe and compliant way, share best practices in remote audits, and explain how they leverage technology to perform virtual audits.
Panelists:
Françoise Schlemmer
Director
Team-NB
After a master's degree in biochemistry, she worked for Medical Device Manufacturers, a Notified Body and set up Quasys Consult consultancy. Since 2001, she is director of TEAM-NB, an association that brings together 26 notified bodies in the medical devices sector. These members issue more than 80% of the certificates worldwide. In this context, she attends meetings under the aegis of the European Commission. She conducts conferences on the trends of the new European regulations.
Andreas Purde
Director Active Medical Devices
TÜV SÜD
Andreas has been working for TÜV SÜD for 16 years now. He started as an auditor and expert for functional safety. Today he leads the unit of active medical devices in Germany and is also responsible for the auditing business.
Simon Richards
VP, Divisional Regulatory Affairs
Abbott Rapid Diagnostics
Simon Richards is VP, Divisional Regulatory Affairs for Abbott Rapid Diagnostics Originally a Ph.D Biochemist, he has worked in the Vaccines and Diagnostics industry for over 27 years. He is the former Chairman of the UK IVD Industry body, BIVDA and part of the key stakeholder team interacting with MHRA on the implementation of the IVD Regulations in the UK. Simon is the IVDR project lead for the Abbott Rapid Diagnostics Division which includes the largest range of Near Patient tests in the world and covers devices in all the new risk categories and in multiple worldwide sites. He is also part of the EU industry body Medtech Europe chairing the MTE IVD Standards committee. He also sit on ISO TC 212 related to Clinical lab testing and iVD systems standards.
Alexey Shiryaev
President of Team-NB and DNV Global Clinical Affairs Manager
Team-NB
Dr. Alexey Shiryaev is the President of Team-NB, European Association of Notified Bodies for medical devices. For the last seven years he has been with DNV Product Assurance AS- notified body for medical devices and is presently serving as Global Clinical Affairs Manager. Prior to joining the notified body, he had completed medical studies, doctoral and post-doctoral training and had specialized in paediatric surgery.