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

Medical Device Classification
MDR 2017/745
Monir El Azzouzi

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

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.

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

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.

Learn more about
the Medical
Device
Classification
READ MORE

The document discusses medical device regulation, including: - Why regulation is needed due to past issues like thalidomide - The definition of a medical device and what is/isn't included - An overview of the regulatory framework and requirements in countries like Australia, Europe, and the US - Key parts of the regulatory process include classifying devices based on risk, meeting regulatory requirements through conformity assessments, maintaining quality management systems, and providing technical documentation

EU Medical Device Classification MDR 2017/745

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The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.

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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

Medical device classification following MDR 2017/745

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