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Class medical device (MDD) - Classification help

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Aleksandra Sorokina

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Our device is referred to IIb class (Rule 10 annex IX) in accordance with MDD 93/42. Some third-party accessories included in the delivery set of our device are referred to class III (Rule 6,7,8) annex IX) in accordance with MDD 93/42. The device is not surgically invasive.
1. Is it possible to refer the system to IIb class, if some of its accessories are referred to III class?
 
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Ronen E

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Aleksandra Sorokina said:
Our device is referred to IIb class (Rule 10 annex IX) in accordance with MDD 93/42. Some third-party accessories included in the delivery set of our device are referred to class III (Rule 6,7,8) annex IX) in accordance with MDD 93/42. The device is not surgically invasive.
1. Is it possible to refer the system to IIb class, if some of its accessories are referred to III class?
Click to expand...
Before this question can be answered, it's crucial to clarify beyond any doubt the sales configuration:
"Some third-party accessories included in the delivery set of our device"
This can be either
- A logistics arrangement, where several different and separate products are shipped together (commercially);
- A System or Procedure Pack as defined in the MDD Article 12; or
- A single medical device (what you refer to as "the system"), comprised of your device and the third-party accessories.
 
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