The document discusses the regulatory changes under MDR 2017/745, which aims to streamline regulations from three directives to two, introduces stricter requirements, and emphasizes improved post-market surveillance following the PIP breast implant scandal. It outlines the medical device classification system in Annex VIII, detailing four categories of devices and their corresponding risk classes, specifically highlighting Class I subclasses. Additionally, it notes that Class I products can be self-declared, while subclasses require notified body involvement for certain specifications.

1. Medical Device Classification
MDR 2017/745
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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
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