IPN - Instituto Pedro Nunes - MDR Training: European Regulation 2017/745 on Medical Devices - 5th edition

Clique aqui para a versão em português. 


Instituto Pedro Nunes is promoting the 5th edition of training on the European Regulation EU 2017/745 on Medical Devices. This training, via E-learning, runs from May 22nd to June 14th, 2024.

This training aims to inform participants of the regulatory changes set out in the MDR regulation, highlighting changes relating to technical documentation and the safety and performance requirements of different medical devices.

Registration until May 17th here. 

At the end of the training, trainees should be able to:

• Define the contents of the technical documentation (Annexes II and III) in light of European Regulation EU 2017/745;
• Know the main changes to the regulation of medical devices and their impact on the classification of the medical device;
• Characterize the impact of European Regulation EU 2017/745 on the process of affixing the CE marking;
• Contextualize the general security and performance requirements (MDR-Annex I);
• Identify the duties and rights of the DM manufacturer in light of European Regulation EU 2017/745.

The training will be led by Sandra Balseiro,master in Cellular Biology and degree in Biology from the University of Coimbra. She has experience in the ISO 13485 standard since 2005, as Quality Manager and Technical Director, having been part of the first IVD company certified by the standard in Portugal (Genebox). Since 2007, she has been a Quality Auditor for the EN ISO 13485 and EN ISO 9001 standards and additional standards of the DMs/IVDs directives, namely ISO 14971 and IEC 62366 and IEC 60601 and IEC 62304. Her experience in the teaching field began in 2003 as a Teacher Guest, at ESALD - Castelo Branco and ESTeSL - Lisbon (areas of Molecular Biology, Human Genetics, Molecular Genetics and Molecular Pathology). She has been a trainer and certification support consultant for around 10 years, having assisted in the certification process of various types of DMs / IVDs from multiple companies.

IPN is an Entity Accredited by DGERT (Certificate 2376-2016). At the end of the action, participants will be entitled to a Professional Training Certificate.