Medical device classification following MDR 2017/745
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MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
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Medical device classification following MDR 2017/745
- 1. Medical Device Classification MDR 2017/745 Monir El Azzouzi
- 2. MDR 2017/745 - Regulatory Changes ● Streamline of the regulation ○ From 3 Directives, we arrive to 2 Regulations ● Regulation are more stringent ● Regulation define the Technical Documentation content ● More Surveillance ● Changes to the Post-market Surveillance and Vigilance ● EUDAMED creation ● Update of the requirements on Importers and Distributors
- 3. Why? Some of you ask this question
- 4. PIP scandal A French company called PIP created a scandal. They were manufacturing breast implants. To stay competitive, the decided to use an industrial gel instead of a biocompatible one which was more expensive. After some complaints where patient saw their implants leaking, the root cause was discovered. During this scandal, the Notified Body was also judged guilty. After that, the regulation should be changed to keep the products on the market safe.
- 5. Annex VIII - Medical Device Classification A Medical Device should first be classified to understand the risk it can have for the patients. The Annex VIII of the MDR 2017/745, contains a list of rules. There are 4 categories for the rules: - Non-Invasive Devices - Invasive Devices - Active Devices - Special rules And there is 4 possible classes - Class I - Class IIa - Class IIb - Class III
- 6. Class I Subclasses The devil is on the details The class I is the one with the lower risk. The specificity is that it’s the only one that contains subclasses. - Class Is: Product under class I which are delivered sterile - Class Im: Product under class I with a measuring function - Class Ir: Product under class I which are reprocessed to be reused. The subtlety is the fact that for class I there is no need to have a Notified Body to put your product on the market (Self-declaration) But for the subclasses we need a Notified Body only for the specificity of the subclass.
- 7. Learn more about the Medical Device Classification READ MORE