Following the entry into force of Regulation (EU) 2017/745 in May 2021, on 26 May 2022 it will be the turn of Regulation (EU) 2017/746. The new regulation, also known as IVDR, will apply to in vitro diagnostic medical devices and will be mandatory for all organisations manufacturing, importing or distributing in vitro diagnostic medical devices. Among other new features, all organisations will have to ensure the traceability of the supply chain and implement a quality and risk management system.
The Basque Health Cluster has organised a conference on 27 October for all manufacturing, importing or distributing organisations of this type of products that wish to learn about the changes brought about by Regulation (EU) 2017/746.
The conference will be held in person at the BIC building of the Science and Technology Park of Vizcaya, with limited capacity and always respecting the measures imposed for that time. There will also be the possibility of being viewed by streaming.
Agenda
9:30 Changes of the entry into force of the new IVDR Regulation.
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- Speaker: Gloria Hernández, Director of Notified Body 0318 (AEMPS).
10:15 Quality Management System: General review of the Quality Management of Medical Devices (MD/IVD) companies.
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- Speaker: Eider Fortea, CEO of deviCE Sistemas.
11:00 BREAK
11:20 Technical Documentation: Structure and Management
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- Speaker: Miguel Ángel Campanero, CEO of A3Z advanced.
12:05 Analytical Validation vs. Clinical Performance Verification (Usability)
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- Speaker: Rocio Diaz, Corporate Director of Research, Quirónsalud.
12: 50 Practical Cases
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- Speaker: Biolan
13:10 End