Classification And Marketability Of Medical Devices (1)
Classification and marketability of Medical Devices (1)Classification ofMedical DevicesMedical Devicem:Level 1:KindMedicalDeviceLevel 2:UseLevel nNonInvasiveRules 1-4InvasiveRules 5-8ActiveRules 9-13SpecialRules 14-22Case a,b,cCase a,b,cCase a,b,cCase a,b,cCategoryN(page 2)CategoryI(page 3)CategoryA(page 4)CategoryS(page 5)Classification ofthe categoryClassification ofthe categoryClassification ofthe categoryClassification ofthe categoryClassification and Marketability of Medical Devices (Workflows and Tables)Sofia Almpani, School of Electrical and Computer Engineering, NTUA, Greece, salmpani@sch.grNaming ofCategoryofMedicalDeviceex. A10bfrom the Characteristics ofMedicalDevice:Level 1 A: ActiveLevel 2 10: Rule 10Level 3 b: case b
Classification and marketability of Medical Devices (2)Non-InvasiveDevicesRule 1N1 Class IRule 2ChanellingOrStoringa)ConnectWithADN2a Class IIab)ForStoringOrgansN2b Class IIbaRule 3ModifyingCompositionc)BloodBagsN2c Class UsedPrincipallyN3a Class IIbN3b Class IIaCategories of MedicalDevicesLevel 1:KindLevel 2:UseLevel 3:Specific casec)InVitroN3c Class IIIClassification and Marketability of Medical Devices (Workflows and Tables)Sofia Almpani, School of Electrical and Computer Engineering, NTUA, Greece, salmpani@sch.grRule 4ContactInInjuredSkinN4a Class IN4b Class IIbc)ManageMicroenvironmentN4c Class IIa
Classification and marketability of Medical Devices (3)InvasiveDevicesRule 5Notsurgicallya)TransientI5a Class Ib)ShortTermRule 6SurgicallyTransientI6 Class IIaa) CirculatorySystemI6a Class IIIb)ReusableInstrumentsI5b Class IIaI6b Class ffectI5c Class IIbRule 7SurgicallyShortTermI7 Class IIaa)CirculatorySystem/BiologicalEffectI7a Class IIIb)Ionization/ChemicalChanges/MedicinesI7b Class IIaI6c Class IIbClassification and Marketability of Medical Devices (Workflows and Tables)Sofia Almpani, School of Electrical and Computer Engineering, NTUA, Greece, salmpani@sch.grRule 8SurgicallyLongTermI8 Class IIba)TeethI8a Class hangeI8b Class IIICategories of MedicalDevicesLevel 1:KindLevel 2:UseLevel 3:Specific case
Classification and marketability of Medical Devices (4)Active DevicesRule 9TherapeuticRule 10DiagnosisMonitoringA10 Class IIaa)TherapeuticEnergyA9a Class IIab)IonizingA9b Class IIbc)ConnectingWithImplantablesA9c Class IIIa) VisibleSpectrumA10a Class Ib)Radiology/CentralSystemsA10b Class IIbRule 11SoftwareTherapeuticA11 Class IIaa)PossibleIrreversibleHealthDeteriorationA11a Class IIIRule 13AllOtherADRule 12MoveSubstancesA12 Class IIaA13 Class Ia)PotentiallyHazardousA12a Class IIbb)PossibleSeriousHealthDeteriorationA11b Class IIbc)OthersSoftwaresa11C Class IClassification and Marketability of Medical Devices (Workflows and Tables)Sofia Almpani, School of Electrical and Computer Engineering, NTUA, Greece, salmpani@sch.grCategories of MedicalDevicesLevel 1:KindLevel 2:UseLevel 3:Specific case
Classification and marketability of Medical Devices (5)Devices withSpecial RulesRule 14MedicalSubstanceS14 Class IIIRule 15SexualtransmittedS15 Class IIbRule 16Disinfectinga) ImplantableS15a Class IIISpecialCases inClass IMeasuringSm Class ImRule 17XrayS17 Class IIaRule 18DerivativesS18 Class IIIRule 19Nanomateriala)ContactLenses/InvasiveDevicesS16a Class IIba)HighExposureS19a Class IIIb)MedicalDevicesS16b Class IIab)LowExposureS19b Class IIbc)NegligibleExposureS19c Class IIaSterileSs Class IsClassification and Marketability of Medical Devices (Workflows and Tables)Sofia Almpani, School of Electrical and Computer Engineering, NTUA, Greece, salmpani@sch.grRule 20InhalationS20 Class IIaa)LifeThreateningS20a Class IIbRule 21ViaBodyOrificeRule 22IntegratedDiagnosticS22 Class IIIa)Metabolism/StomachS21a Class IIIb)OnCavitiesS20b Class IIac)NegligibleExposureS20c Class IIbCategories of MedicalDevicesLevel 1:KindLevel 2:UseLevel 3:Specific case
Classification and marketability of Medical Devices (6)MarketableMedicalDeviceWorkflow for CE ionOfConformityInClass IClass ImClass IClass eConditionsDeclarationOfConformityInClass calRequirementsDeclarationOfConformityInClass IIbDeclarationOfConformityInClas IIaTypeExaminationFor Manufacturer's Declaration of Conformity thefollowing five requirements must be fulfilled:1. Conformity Assessment & Technical File of theMedical Device - Annex VII2. Manufacturer appointing a EuropeanAuthorized Representative (EAR) as in 93/42/EEC,Article 1 parag.23a. European Competent Authorities (ECA) as in93/42/EEC, Article 14 for Class I3b. Quality Assurance from Notified Body forClasses IIa,IIb,III4a. Notified body Involvement for Classes Im, IsAnnex V, Article 3 Parag.14b. Type examination from NB for Classes IIb,III Annex III5. Design Dossier Certificate in Full QualityAssurance for Class III Annex II yDesignDossierCertificate ure:NoClassification and Marketability of Medical Devices (Workflows and Tables)Sofia Almpani, School of Electrical and Computer Engineering, NTUA, Greece, esign:NoManufacture:YesDesign:NoManufacture:No
Classification and marketability of Medical Devices (7)Medical Devices’ Facts (codes1) for each categoryNon-Invasive DevicesInvasive 2I7CategoryActive 11aMDA0315aMDN1104A11bMDA0315bMDN1101Devices with Special RulesS16aS17S18S19aCategories in each Class:Class I: N1, N4a, I5a, I6b, A10a, A11c, A13 (Class Is: Ss/Class Im:Sm)Class IIa: N2a, N2b, N3b, N4c, I5b, I6, I7, I8a, A9a, A10, A11, A12, S16b, S17, S19a, S20, S21bClass IIb: N2c, N3a, N4b, I5c, I6c, I7a, I8, A9b, A10b, A11b, A12a, S15, S16a, S19b, S20a, S21cClass III: N3c, I6a, I7b, I8b, A9c, A11a, S14, S15a, S18, S19a, S21a, S221Retrieved from: /?uri CELEX:32017R2185&qid 1517955018255&from en In cases where the codes don’t describe specifically acategory other (random) coding is applied (black color). In cases where more than one category belongs in the same code, letters a,b,c, and ST are used.Classification and Marketability of Medical Devices (Workflows and Tables)Sofia Almpani, School of Electrical and Computer Engineering, NTUA, Greece, salmpani@sch.gr
Classification and marketability of Medical Devices (8)Marketable and Non-Marketable Medical Devices in each class (randomly)ClassClass IClass IsClass ImClass IIaMarketable: sMDN1204aMDS1006MDA0315cDeviceR20Class DN1213bMDN1213cDeviceR22Class IIIClassification and Marketability of Medical Devices (Workflows and Tables)Sofia Almpani, School of Electrical and Computer Engineering, NTUA, Greece, S1003MDS1007aMDN1102
Classification and marketability of Medical Devices (1) Classification and Marketability of Medical Devices (Workflows and Tables) Sofia Almpani, School of Electrical and Computer Engineering, NTUA, Greece, salmpani@sch.gr Classification of Medical Devices Level 1: Kind Level 2: Use Level 3: SpecificCase Non-Invasive Rules 1-4 Case a,b,c Category
Slide 2 Market –Marketability Analysis Market analysis is a study of the demand for and supply of a property type and the specific market area for that property type. Marketability analysis is a study of how a specific property is expected to perform as it competes for
M Market Analysis - Look at surrounding competition and market demand. C Capture (Marketability) Determine how much of the . Studio with Kitchenette 2,245 - 2,753 - One Bedroom 2,405 2,317 3,351 - Two Bedroom 3,203 - 4,000 - Competitive Property #3 Legacy House of Ogden
classification has its own merits and demerits, but for the purpose of study the drugs are classified in the following different ways: Alphabetical classification Morphological classification Taxonomical classification Pharmacological classification Chemical classification
The medical devices regulatory framework has a classification system for medical devices and IVDs, as per the regulations of Act 101 of 1965. A medical device, other than an IVD medical device, has the medical device classification applying under
definition of the Medical Device. If it matches, then the software is called MDSW. Chapter 3 Explains also Classification. Classification determines the risk class of the Medical Device. The higher the risk class the stricter the MDR requirements are. Classification is comparing the intended use of the Medical Device with the classification .
used in these Classification Rules have the meaning given to them in the Glossary to these Classification Rules. 1.12 References to a 'sport' in these Classification Rules refer to both a sport and an individual discipline within a sport. 1.13 The Appendices to these Classification Rules are part of these Classification Rules
Classification of IVD medical devices V3.0 December 2020 Page 5 of 24 . Introduction . This guidance on the classification of in -vitro diagnostic medical devices (IVDs) is to assist manufacturers to classify their IVDs according to the Australian classification r ules for supply i
2019 AMC 8 Problems Problem 1 Ike and Mike go into a sandwich shop with a total of 30.00 to spend. Sandwiches cost 4.50 each and soft drinks cost 1.00 each. Ike and Mike plan to buy as many sandwiches as they can, and use any remaining money to buy soft drinks. Counting both sandwiches and soft drinks, how many items will they buy? Problem 2 Three identical rectangles are put together to .
