The new European In Vitro Diagnostic Medical Devices Regulation came into force last year and with it a series of changes for manufacturers, distributors, importers, authorised representatives, among other market players.
Instituto Pedro Nunes is promoting training on the New European Regulation EU 2017/746 on In Vitro Diagnostic Medical Devices
. This distance learning training runs from April 11 to May 11, 2023
. Registration until April 7
through the form
This training aims to elucidate the participants to the regulatory changes set out in the new IVDR regulation, highlighting the changes regarding technical documentation, safety and performance requirements of the different IVDs.
At the end of the training, the trainees should be able to:
- Define the contents of the technical documentation (Annex II and III) in the light of the European Regulation EU 2017/746;
- Elucidate on the changes to the regulation on in vitro diagnostic medical devices and its impact on the classification of IVDs;
- Elucidate on the impact of the European Regulation EU 2017/746 on the process of affixing the CE marking;
- Contextualise the general safety and performance requirements (IVDR-Annex I);
- Clarify the duties and rights of the manufacturer of DMs in light of the European Regulation EU 2017/746.
More details and information firstname.lastname@example.org
Please refer to the attached PDF for the full Training Programme.
The training will be conducted by Sandra dos Santos Caramujo Balseiro, PhD candidate in Cellular and Molecular Biology, 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 is Quality Auditor of the standards EN ISO 13485 and EN ISO 9001 and accessory standards of the DMs/IVDs, namely ISO 14971 and IEC 62366 and IEC 60601 and IEC 62304. For about 10 years she has been a trainer and certification support consultant, having assisted in the certification process of various types of DMs/IVDs of multiple companies.
IPN is an Accredited Entity by DGERT (Certificate 2376-2016). At the end of the action participants will be entitled to a Vocational Training Certificate.