How to comply with MDR when products contain CMR Substances?
In this episode, we will discuss CMR which are some substances that can be dangerous for your health. They are classified by legislation and we will explain to you what you should do.
Ana Luiza Cassin Duz, Clinical Specialist will help us to define what are the MDR requirements and how you can follow the rules and be compliant. In a previous episode, Martin Witte from TÜV SÜD explained that one of the common issues discovered during an MDR audit is the fact that manufacturers were not looking at CMR substances on their products.
So I hope this episode will provide you with all the methods you have to follow to be EU MDR 2017/745 compliant.
Who is Ana Luiza Cassin Duz?
She holds a Bachelor’s Degree in Biological Sciences, a Master’s Degree in Cellular Biology, a Ph.D. in Biological Sciences, and an MBA in Quality Management.
She has worked for the past 10 years in the quality, regulatory and clinical evaluation of various types of medical devices, such as Biological Heart Valve, Endoprosthesis, Inorganic valved conduit, Annular Rings; as well as, Extracorporeal circulation machine, Defibrillator, Cardioverter, and Patient monitors; in addition to Intrastromal corneal ring, Intraocular lens, and Contact lenses.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with a big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…
Links
- Ana Luiza Cassin Duz Linkedin Profile: https://www.linkedin.com/in/ana-luiza-cassin-duz-clinical/
- ISO 10993-1 standard: https://www.evs.ee/en/evs-en-iso-10993-1-2020
- TUV SUD Biological Evaluation: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/iso-10993-biological-evaluation-of-medical-devices
- Guideline on Phtalate in Medical Devices: https://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scheer_consultation_08_en
- Scheer: https://titck.gov.tr/storage/Archive/2019/contentFile/EK-22-SCHEER%20Guideline%20on%20the%20benefit-risk%20assessment%20of%20the%20presence%20of%20phthalates%20in%20certain%20medical%20devices_3f032f9a-2bba-4e6b-91ac-f4ab0353d367.pdf
- Blood Transfusion association: https://www.edqm.eu/sites/default/files/medias/fichiers/Transfusion/Events/impact_of_mdr_on_the_suppliers_and_their_relations_with_blood_establishments_by_pascale_van_hoydonck.pdf
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