and the provisions of…..and the provisions of…..

the Medical Devicesthe Medical DevicesRegulationsRegulations

Medical Devices AgencyMedical Devices Agency

MEDICAL DEVICES MEDICAL DEVICES AGENCYAGENCY

MEDICAL DEVICES MEDICAL DEVICES AGENCYAGENCY

...meet appropriate standards safety,...meet appropriate standards safety,quality and performance and thatquality and performance and thatthey comply with the Directives…..they comply with the Directives…..

primary source of informationprimary source of informationon safety medical devices in UK on safety medical devices in UK

FUNCTIONSFUNCTIONSFUNCTIONSFUNCTIONS

safetysafety

> 8000 adverse events annually> 8000 adverse events annually

largest user reporting system in worldlargest user reporting system in world

issue Advisory Notices to H/Sissue Advisory Notices to H/S

evaluationevaluation

independent programmeindependent programme

advise purchasers, usersadvise purchasers, users

regulationregulation

safetysafety

> 8000 adverse events annually> 8000 adverse events annually

largest user reporting system in worldlargest user reporting system in world

issue Advisory Notices to H/Sissue Advisory Notices to H/S

evaluationevaluation

independent programmeindependent programme

advise purchasers, usersadvise purchasers, users

regulationregulation

MEDICAL DEVICE?MEDICAL DEVICE?MEDICAL DEVICE?MEDICAL DEVICE?

“…“…any article…intended by manufacturerany article…intended by manufacturerfor human use:for human use:

diagnosis, prevention,monitoring, diagnosis, prevention,monitoring, treatment, alleviation of diseasetreatment, alleviation of disease

investigation, replacement, modificationinvestigation, replacement, modificationof anatomy or physiological processof anatomy or physiological process

control conception”control conception”

(not acting metabolically, pharmacologically)(not acting metabolically, pharmacologically)

DEVICES DIRECTIVESDEVICES DIRECTIVESDEVICES DIRECTIVESDEVICES DIRECTIVES

active implantableactive implantable medicalmedical in vitro diagnosticsin vitro diagnostics

active implantableactive implantable medicalmedical in vitro diagnosticsin vitro diagnostics

CE MARKINGCE MARKINGCE MARKINGCE MARKING

CECE compliance with compliance with essential requirementsessential requirementsof safety and performance;of safety and performance;fit for purpose; fit for purpose; positive risk/benefit analysispositive risk/benefit analysis

(design, manufacture, microbiological, toxicological, electrical, radiation, labelling)(design, manufacture, microbiological, toxicological, electrical, radiation, labelling)

MANUFACTURERMANUFACTURERMANUFACTURERMANUFACTURER

what essentialwhat essentialrequirements?requirements? what essentialwhat essentialrequirements?requirements?

what information?what information?(non-clinical, clinical)(non-clinical, clinical)

what information?what information?(non-clinical, clinical)(non-clinical, clinical)

CECECECEapplication to notified bodyapplication to notified body

post-market surveillance,post-market surveillance,vigilance vigilance

CLINICAL DATACLINICAL DATACLINICAL DATACLINICAL DATA

COMPILATION COMPILATION OF SCIENTIFIC OF SCIENTIFIC LITERATURELITERATURE

COMPILATION COMPILATION OF SCIENTIFIC OF SCIENTIFIC LITERATURELITERATURE

CLINICALCLINICALINVESTIGATIONINVESTIGATION CLINICALCLINICALINVESTIGATIONINVESTIGATION

INDICATIONS FOR INDICATIONS FOR CLINICAL INVESTIGATIONCLINICAL INVESTIGATION

INDICATIONS FOR INDICATIONS FOR CLINICAL INVESTIGATIONCLINICAL INVESTIGATION

new devicenew device new functionnew function new featurenew feature modificationmodification new materialnew material new manufacturernew manufacturer ex vivo cannot mimic clinical situationex vivo cannot mimic clinical situation

new devicenew device new functionnew function new featurenew feature modificationmodification new materialnew material new manufacturernew manufacturer ex vivo cannot mimic clinical situationex vivo cannot mimic clinical situation

HANDLING BY COMPETENT HANDLING BY COMPETENT AUTHORITYAUTHORITY

HANDLING BY COMPETENT HANDLING BY COMPETENT AUTHORITYAUTHORITY

NOTIFICATIONNOTIFICATIONNOTIFICATIONNOTIFICATION

ASSESSMENTASSESSMENTASSESSMENTASSESSMENT

60 DAYS60 DAYS60 DAYS60 DAYS

(alternative is on basis of LREC opinion)(alternative is on basis of LREC opinion)

NOTIFIED BODYNOTIFIED BODYNOTIFIED BODYNOTIFIED BODY

independent accreditation bodiesindependent accreditation bodies 63 in Europe63 in Europe audit manufacturer regularly, approve audit manufacturer regularly, approve

changeschanges

independent accreditation bodiesindependent accreditation bodies 63 in Europe63 in Europe audit manufacturer regularly, approve audit manufacturer regularly, approve

changeschanges

marketmarketproductproduct

CLASSIFICATIONCLASSIFICATIONCLASSIFICATIONCLASSIFICATION

class I: class I: eg throat swabseg throat swabs class IIa: class IIa: eg active deviceseg active devices class IIb: class IIb: eg implantableseg implantables class III: class III: CNS, CVS contactCNS, CVS contact active implantables: eg pacemakersactive implantables: eg pacemakers

class I: class I: eg throat swabseg throat swabs class IIa: class IIa: eg active deviceseg active devices class IIb: class IIb: eg implantableseg implantables class III: class III: CNS, CVS contactCNS, CVS contact active implantables: eg pacemakersactive implantables: eg pacemakers

COMPETENT COMPETENT AUTHORITYAUTHORITY

COMPETENT COMPETENT AUTHORITYAUTHORITY

negotiate, implementnegotiate, implement manage clinical investigation systemmanage clinical investigation system appoint, audit notified bodiesappoint, audit notified bodies register, audit class I manufacturersregister, audit class I manufacturers manage Vigilance systemmanage Vigilance system enforce (including Safeguard action)enforce (including Safeguard action)

negotiate, implementnegotiate, implement manage clinical investigation systemmanage clinical investigation system appoint, audit notified bodiesappoint, audit notified bodies register, audit class I manufacturersregister, audit class I manufacturers manage Vigilance systemmanage Vigilance system enforce (including Safeguard action)enforce (including Safeguard action)