medical device regulations
TRANSCRIPT
Medtechregs 101
GeneratorTHE
powered by
Every medical device is regulated in some way by regulatory agencies
FDATGA
EuropeanCommissionHealthCanadaEtc.
The rules are different (but similar) for each regulatory agency…
Lets start with product classification
FDA
http://www.emergogroup.com/resources/videos-us-fda-regulatory-process
FDAClassI
ClassII
ClassIII
LowRisk
HighRisk
Intended Use is the general purpose of the medical device or its function (what you “claim” the medical device does)
Indications for Use describe the disease or condition the medical device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population
Have a Go…
what is your intended use and indications for use?
Without boring you with too many details, FDA has established several general categories based on the medical specialty: CFR 21 Parts 862 to 892.
Thedetailsprovidedgivemesomeideaifmyintendeduseandindicationsforusealignwiththisspecificregulation.
YoualsodiscovertheFDAdeviceclassification
Find the regulation
Gotothe FDAProductClassificationDatabase andtypeintheregulationsnumberyoufound.Ifyoufindmorethanonepossibility,thenyouwillneedtorepeatthisprocessforeach.
Youcanthenrevieweachindividualcodetodeterminethebestoptionforyourproductbyclickingoneachcode.
Find the product codes
Herearetheoptions:ClassI(lowtomoderaterisk): generalcontrolsClassII(moderatetohighrisk):generalcontrolsand SpecialControlsClassIII(highrisk):generalcontrolsand PremarketApproval(PMA)
Determine FDA path to market
EU
Determineifyourmedicaldeviceis:•Non-Invasive•Invasive•Active
DeterminetheEUclassificationper AnnexIXintheMedicalDeviceDirective(93/42/EECasmodifiedby2007/47/EC)
• ClassI• ClassIIa• ClassIIb• ClassIII
And Software?
Softwareintendedbythemanufacturertobeusedforoneormoremedicalpurposes(asdefinedasamedicaldevice),isamedicaldevice.
Standalonesoftwareforgeneralpurposeswhenusedinahealthcaresettingisnotamedicaldevice.
Software as a device?
ClassA: Noinjuryordamagetohealthispossible
ClassB: Non-SERIOUSINJURYispossible
ClassC: DeathorSERIOUSINJURYispossible
IEC 62304
This is only your
STARTING point
Product development and design controls
Quality Management SystemsISO13485- MedicalDevices– Qualitymanagementsystems–Requirementsforregulatorypurposes
ISO9001- QualityManagementSystems–Requirements
GMP- GoodManufacturingPractices-
ISO14971- RiskManagementforMedicalDevices-
What is a quality system?
Simplified,itmeansasetwayofdoingallthetasksinvolvedinthedevelopmentandmanufactureof
thedevice/item
Some of the processes controlled by ISO guidelines and make up a quality system:
PurchasingInwards
goodscheck Manufacture
Releaseforsale
Equipmentmaintenance
Personneltraining
Distribution,warehouse
Customerreceivesgoods
Customersatisfaction
Approvalofsuppliers
Quality systems
Ifacompaniessystemsaresatisfactory,theyare‘ISOcertified’.• TheyareawardedwithanISOcertificate(internationallyrecognised)
CanoutsourcethedevelopmentandmanufactureofamedicaldevicetoacompanythathasISO13485certification
• Design and Development Planning• Design Input• Design Output• Design Review• Design Verification• Design Validation• Design Transfer• Design Changes• The Design History File
Key elements of design control
DesignControlmandatesaformal,defined"StartDate."
Design control “start” date
Describeorreferencedesign&developmentactivitiesanddefineresponsibilityforimplementation
Design & Development planning
Addresstheintendeduse ofthedevice,includingtheneedsoftheuser/clinicianandpatient,theuseenvironment,aswellasmeetingtherequirementsofanyapplicablestandardsmandatedinthemarket(s)inwhichtheproduct willbesold
Design Input
Allowsevaluationofconformancetodesigninputrequirements(acceptancecriteria,identifiesdesignoutputsthatareessentialfortheproperfunctioningofthedevice)
Design OUTPUT
Formalreviewsofthedesignresultsatplannedstagesofthedevice’sdevelopment
Design REVIEWS
Verifying,testingand/orinspectingthedevicedesigntoconfirmthatthedesignoutputmeetsthedesigninputrequirements
Design Verification
Performedunderdefinedoperatingconditionsoninitialproductionunits,lots,batchesorequivalents
Design VALIDATION
Themanufacturerensuresthatthedevicedesigniscorrectlytranslatedintoproductionspecifications– thisensuresthatmanufactureddevicesarerepeatedlyandreliablyproducedwithinproductandprocesscapabilities
Design TRANSFER
Allchangesmustbeidentified,documented,reviewedandapprovedbeforebeingimplemented.Therearetwoprincipaladministrativeelements/activitiesinvolvedinthecontrollingofdesignchanges:
1. DocumentControl2. ChangeControl
Design CHANGES
Clear as muD?
WANT TO KNOW MORE?GET IN TOUCH!
www.monash.edu/[email protected]/monashGENERATOR
7InnovationWalkAG01-04(ClaytonCampus)[email protected]