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

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?
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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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