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Summary of safety and clinical performance in GSPR MDR

duinyk

Involved In Discussions
#1
Hey guys, I have a little interpretation problem with article 32 which is summary of safety and clinical performance.

So, this clause starts by saying 1) Required for implantable devices and for class III devices, other than custom‐made or investigational devices. But also say in 2. it says that Manufacturer must mention on label or IFU where summary is available. Does this mean this information would be added to only IFUs for devices which are implantable devices and for class III devices, or regardless of the device all IFUs must be formatted appropriately to each device, to include the safety and clinical performance of the device? To help my device in question is a class IIa device and is not an implantable device. So I am confused if this applies to my device or not.

Thanks
 
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Marcelo

Inactive Registered Visitor
#2
Article 32 is applicable only to implantable and class III devices (other than blah...), so if your device is II and not implantable (I would take care that due to the changing in wording, some devices which were not implantable under the MDD will be implantable under the MDR), it's not applicable to your device.

The requirement on label or IFU is for the manufacturer of devices under Article 32 to mention where the SSCP is available (either a mention to EUDAMED or a link to the EUDAMED link).
 

duinyk

Involved In Discussions
#3
Considering Article 2 defines ‘clinical benefit’ as the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;
For an introducer device intended for the percutaneous introduction of diagnostic or therapeutic devices, into the vasculature,

will Article 2 definition of clinical benefits apply to my device? as my device only introduces the device that actually brings in the clinical benefit.

Hope this makes sense.

Thanks
 
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