It's not easy to classify a Medical Device. You need to have all the device features and intended purpose to really determine its classification.
In this video, I will show you some examples and you'll have to find the answer.
I will also provide you with different technics that were used with MDD 93/42/EC and may still be applicable for MDR 2017/745.
I create a free classification form that you can download at [ Ссылка ]
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► 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 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 now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses...
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► Links from the Video
■ Blog Post - Medical Device Classification: [ Ссылка ]
■ Presentation download: [ Ссылка ]
■ Borderline manual: [ Ссылка ]
■ Meddev 2.4/1 rev 9: [ Ссылка ]
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► Social Media to follow
■ Monir El Azzouzi Linkedin: [ Ссылка ]
■ Twitter: [ Ссылка ]
■ Pinterest: [ Ссылка ]
■ Instagram: [ Ссылка ]
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#medtech #medicaldevice #compliance
How to classify a Medical Device? (EU MDR Case Studies)
Теги
medical devicesmedtech industrymedical device regulationregulatory affairs medical devicesmedical device trainingmedical devices manufacturingmedical devices industrymedical devices classificationmdr 2017/745eu mdrce markingmedical devicece markeu mdr 2017 745eu mdr webinareu mdr regulationeasy medical devicelearn medical devicesregulatory affairsmedical device classificationce marking technical fileeasy medical device.com/mdr