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 !
 
Elsmar Forum Sponsor

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

Involved In Discussions
#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.
 
Thread starter Similar threads Forum Replies Date
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C How to Classify a Medical Device Other Medical Device and Orthopedic Related Topics 6
W Let's play... Classify My Medical Device!!! EU Medical Device Regulations 15
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
A How does Japan PMDA classify Medical Devices - Classification Guidelines Japan Medical Device Regulations 6
D Supplier Quality - How to classify a supplier level Medical Device and FDA Regulations and Standards News 7
Q Do you classify applied parts? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Device Classification - India CDCSO - How to classify the device? Other Medical Device Related Standards 1
O Which part of ISO 14644 describe how can I classify cleanrooms between them? Other ISO and International Standards and European Regulations 0
L How to classify this computer-alike IT device EU Medical Device Regulations 2
M Is it necessary to classify nonconformance as minor, major, observations in an IQA? Internal Auditing 18
E How do you classify Contact Lenses ? Non-invasive, Invasive or Surgically Invasive? Other US Medical Device Regulations 1
I How do you classify/name your CAR (Corrective Action) types? Nonconformance and Corrective Action 6
G How to classify maintenance level of equipments? Manufacturing and Related Processes 3
K Would you classify this as a concession? Document Control Systems, Procedures, Forms and Templates 5
A How many ways do you classify your scrap? Quality Tools, Improvement and Analysis 15
M Indian Medical Device Rules --Manufacturing and Whole sale Lic. Required ? Other Medical Device Regulations World-Wide 0
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 6
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
M The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 0
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 0
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 4
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Medical device Mode Of Action CE Marking (Conformité Européene) / CB Scheme 2
P Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020 Other Medical Device Regulations World-Wide 2
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
S Philippines CMDL (Certificate of Medical Device Listing) Elsmar Cove Forum ToS and Forum Policies 0
M Subcontracting a repair of Medical Devices Canada Medical Device Regulations 0
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Regrind Material in Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
J Medical software Patient outcome Medical Information Technology, Medical Software and Health Informatics 2
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 3
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
N Medical Devices in oxygen rich environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
M Medical Devices Shelf Life ---INDIA Other Medical Device Regulations World-Wide 3
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom