New EU regulations have placed much tougher requirements on the manufacturers of in vitro diagnostic devices. One of the new requirements under the In Vitro Diagnostics Regulation (EU) 2017/746 of the European Parliament and of the Council (IVDR) is that manufacturers create, compile, and maintain Technical Documentation as described in Annex II and Annex III of the Regulation. During the webinar, Technical Files for IVDR’, we will describe the requirements of the IVDR with respect to Technical Documentation and discuss options and formats for how to meet the regulatory requirements. Depending on the classification of devices and conformity assessment route, the technical documentation can be subject to assessment by Notified Bodies to ensure compliance with the requirements. The webinar will also explore key software considerations in relation to the requirements and will provide some insights on how to ensure compliance.
Seán is a graduate of University College Dublin where he completed his B.Sc. and M.Sc. studies, he also completed the M.Sc. in Medical Technology Regulatory Affairs at Cranfield University, UK. He has worked for more than 15 years in the regulated medical device diagnostics industry in quality and regulatory affairs with extensive experience in CE marking and FDA submissions. He has senior management experience with SMEs and multinationals including due diligence and acquisitions activities, with in depth knowledge of design and development processes from concept to market authorizations for all global regions.
Javier has a bachelor’s degree in veterinary sciences with over nine years’ experience in the regulatory affairs field. He joined PharmaLex in 2018 and is now Team Lead of Medical Devices in Spain. He assists medical device companies, including developers of software as medical devices (SaMD), with market access and transition to the new EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Medical Device Regulation 2017/746. Javier brings extensive experience in the registration and maintenance of medical device portfolios and supports international registrations, including within the EU, US FDA, Brazil ANVISA and MENA markets.