Classification of a product according to MDR

#1
Hi,
I'm looking for your opinion about the classification rule to be applied in this case:
The product is actually a cosmetic device, it is a film-forming sticky paste used for local treatment of cracks (no wounds) on the heels and feet. Due to its formulation, the product has unique pain reducing and create a thin protective layer on the affected area. The product works by filling the crack on feet or hands and using a small amount of water to activate and create the protective barrier. A strong and tight seal over and around the protected area is formed, thus ensuring maximal product efficacy.
Our Health authority said that this product should be a medical device. So when I look to the classification rules: I have 2 options:
Rule 21: the product will be classified as class IIa as it is substance based devices
OR
Rule14: our product includes a very low percentage (<1%) of Zinc oxide which is considered as medicinal product and this rule covers devices incorporating, as an integral part, a substance considered, if used separately, to be a medicinal product, and that has an action ancillary to that of the devices. SO if I will consider this rule, the device will be a class III. Knowing that the zinc oxide cannot have an ancillary action because in literature it is well demonstrated that Zinc oxide in paste should be present at 16, 20 and 40 %.
Can someone guide me to proceed.
 
Elsmar Forum Sponsor

planB

Trusted Information Resource
#2
Simona,

assuming that the information of your health authority is indeed "authoritative", it depends on whether you claim ZnO (irrespective of amount) being an active pharmaceutical ingredient (medicinal product) in your product or not. For the former, you would then actually have a device/drug combination product. For the latter, you would have a much easier submission path, if you are in a position to claim that ZnO is just another "material" in the formulation of your medical device, intended to provide a physical barrier similar to a patch.

HTH,
 
#3
Thank you planB,
The product efficacy is due to the presence of gelling agents with polymer (Film forming agent). The zinc oxide is used in the formulation due to its antimicrobial preservative properties. The doubt that I have is that the same film forming agent are used in drug delivery system, so in the case of our product, the zinc oxide can act as medicinal.
Any comments, please?
 

planB

Trusted Information Resource
#4
Simona,

in your case, ZnO seems to _not_ have an action ancillary to that of your device. Whether others do use ZnO as medicinal substance, is not relevant for your device and its associated classification. From what you report, MDR classification Rule 14 does not apply. Have also a look at this industry position paper - quote from p. 3:

As an example, a substance designed to preserve the whole formulation, [...] would not be considered as a substance which, if used separately, can be considered to be a medicinal product.
You might also want to to re-confirm your classification with your notified body.

HTH,
 
Thread starter Similar threads Forum Replies Date
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
S Medical Device Product Classification in South Korea Other Medical Device Regulations World-Wide 1
B FDA Product Classification - Self Treatment Software Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Please explain Medical Device Product Classification Rationale 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Insufflation Tubing & Filter Set Product Classification question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Ajit Basrur Guidance Document - Medical Device Classification Product Codes Other US Medical Device Regulations 1
G Product Release and Component Classification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A FDA "Product Code" Classification Basics US Food and Drug Administration (FDA) 8
B How do I search within a Product Regulatory Classification Category 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Product classification of SFDA for borderline products China Medical Device Regulations 4
L Medical Device FDA Product Classification help needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Classification of a new product - Is it a Medical Device Supplier Quality Assurance and other Supplier Issues 7
M Medical Device Classification Guidelines for Product Registration in Colombia Other Medical Device Regulations World-Wide 12
M MDD Classification - Marketer Has Misclassified A Product? EU Medical Device Regulations 22
P Nonconforming Product classification Nonconformance and Corrective Action 3
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Surgical Instrument Tray Classification EU Medical Device Regulations 5
L Classification under MDR EU Medical Device Regulations 1
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
K Biological indicator system classification under MDR EU Medical Device Regulations 2
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
nadhar2 Classification of Action Items Misc. Quality Assurance and Business Systems Related Topics 3
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
M Classification of Clean Rooms Other Medical Device Related Standards 9
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 3
DuncanGibbons Classification of aerospace parts depending on their risk and criticality etc. Federal Aviation Administration (FAA) Standards and Requirements 3
M Barrier cream classification EU Medical Device Regulations 2
N Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 11
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
D Classification of Syringe (nozzle) of needle free injection system. EU Medical Device Regulations 8
S CE Mark - Classification Confusion EU Medical Device Regulations 12
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
D MDR 2017/745 Classification Guide EU Medical Device Regulations 8
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
M Informational EU MDR Classification Rule 11 – what??? Medical Device and FDA Regulations and Standards News 9
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
A Fire hazard classification - Clause in IEC 60601 about gauze and electricity ISO 14971 - Medical Device Risk Management 0
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
A Device Classification - India CDCSO - How to classify the device? Other Medical Device Related Standards 1
B ASTM F2924-14 /ASTM F3001 - Room temperature classification criteria Other US Medical Device Regulations 0
M Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019) Medical Device and FDA Regulations and Standards News 2
E Wristwatch Skin-proximal glucose sensor - Classification under MDR EU Medical Device Regulations 4
K MEDDEV 2.4/1 rev. 9 Classification EU Medical Device Regulations 1
M Informational USFDA – Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph Medical Device and FDA Regulations and Standards News 0
N Medical Device Re-Classification EU Medical Device Regulations 2
B Class IIB Device - IEC 62304 Software Classification IEC 62304 - Medical Device Software Life Cycle Processes 13

Similar threads

Top Bottom