How to classify a medical device based on MDR?

Biomedical_engeener

Starting to get Involved
#1
Dear Elsmar users,

Could anyone help with classifying medical device, please?
It is custom made craniomaxillofacial implants, mostly cranioplasty implants.
Based on Rule 8 (MDR) would it be classified as class IIb or III ?
MDR says :
" All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:
- are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III "
Many thanks for your opinions !
 
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indubioush

Quite Involved in Discussions
#2
I suggest you ask your "person responsible for regulatory compliance" (PRRC). The MDR requires that you have this person. This person will be able to assess the risk profile of your device and determine the classification based on all the rules.
 

monoj mon

Trusted Information Resource
#3
Dear Elsmar users,

Could anyone help with classifying medical device, please?
It is custom made craniomaxillofacial implants, mostly cranioplasty implants.
Based on Rule 8 (MDR) would it be classified as class IIb or III ?
MDR says :
" All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:
- are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III "
Many thanks for your opinions !
I would suggest you to draw complete risk profile of the device for better understanding and correct classification. However, I guess, your device will be a "Class IIb".

Reason: As you said it is mainly for cranioplasty, it will remain on the exterior surface of the cranial layer. Right! To be in contact with the Central Nervous System of the brain it has to be something like implants used during duraplasty. Examples of such implant are the "Dura Mater Substitutes" or "Suture or sealant to fix the dura mater substitute" used after therapeutic atraumatic intervention or therapeutic intervention after traumatic injury of the brain where surgeon needs to permanently replace the dural layer with an implant to allow proliferation of the fibroblasts for dura mater repair. In that case it has direct contact with the Cerebrospinal Fluid (CSF) as well as Central Nervous System (CNS). So it shall be classified as Class III.

However, if your device is placed towards the interior surface of the cranial layer then there are probabilities when it may come into contact with CNS, such as "brain swelling after surgery" or if your implant is composed of material with swelling capability then it may come into contact with the CNS or if your implant has a degradation profile then the degraded materials may come into contact with the CNS or if your implant has leachables then it may come into contact with the CSF and eventually CNS.

So, there are different aspects (or risk) associated with your device depending on its application. That's why a drawing a complete risk profile would give you a clear picture regarding the classification of your device.
 

bill.Kal

Starting to get Involved
#5
hi community,
here I am again in need of your precious experience. We are preparing to submit a 510(k) for a medical device with numerous predicate devices. Our own has a few accessories, one of which is a field generator for electromagnetic position and orientation tracking.
The system is class II device. For the accessory I have gone through guidance "Medical Device Accessories – Describing Accessories and Classification Pathways" [https://www.fda.gov/media/90647/download].

1. BAsed on what I see in this guidance, the accessories, i.e. in our case the field generator, will be classified as the parent device and only if FDA identifies the need to regulate the accessory differently, they will initiate a classification regulation process on their own? If the latter is the case, how long will the overall submission be delayed in your experience?

2. Or do I need to submit a 513(f) request if I cannot find it in the respective list of accessories [ I have been checking in 84 FR 14865 (Page Not Found

3. Is it possible that the accessory belongs to one of the existing accessory types and I just don't have the experience to identify it? What does your experience say?

Thank ya all!
 
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