1. and the provisions of….. the Medical Devices Regulations Medical Devices Agency

2. MEDICAL DEVICES AGENCY...meet appropriate standards safety, quality and performance and that they comply with the Directives….. primary source of information on safety medical devices in UK

3. FUNCTIONSFUNCTIONS p safety > 8000 adverse events annually largest user reporting system in world issue Advisory Notices to H/S p evaluation independent programme advise purchasers, users p regulation p safety > 8000 adverse events annually largest user reporting system in world issue Advisory Notices to H/S p evaluation independent programme advise purchasers, users p regulation

4. MEDICAL DEVICE? …any article…intended by manufacturer for human use: diagnosis, prevention,monitoring, treatment, alleviation of disease investigation, replacement, modification of anatomy or physiological process control conception (not acting metabolically, pharmacologically)

5. DEVICES DIRECTIVES p active implantable p medical p in vitro diagnostics p active implantable p medical p in vitro diagnostics

6. CE MARKING CE compliance with essential requirements of safety and performance; fit for purpose; positive risk/benefit analysis (design, manufacture, microbiological, toxicological, electrical, radiation, labelling)

7. MANUFACTURERMANUFACTURER what essential what essentialrequirements? requirements? what information? (non-clinical, clinical) what information? (non-clinical, clinical) CECE application to notified body post-market surveillance, vigilance

8. CLINICAL DATA COMPILATION OF SCIENTIFIC LITERATURECOMPILATION LITERATURE CLINICAL CLINICALINVESTIGATION INVESTIGATION

9. INDICATIONS FOR CLINICAL INVESTIGATION p new device p new function p new feature p modification p new material p new manufacturer p ex vivo cannot mimic clinical situation p new device p new function p new feature p modification p new material p new manufacturer p ex vivo cannot mimic clinical situation

10. HANDLING BY COMPETENT AUTHORITY NOTIFICATIONNOTIFICATION ASSESSMENTASSESSMENT 60 DAYS (alternative is on basis of LREC opinion) (alternative is on basis of LREC opinion)

11. NOTIFIED BODY p independent accreditation bodies p 63 in Europe p audit manufacturer regularly, approve changes p independent accreditation bodies p 63 in Europe p audit manufacturer regularly, approve changes marketproduct

12. CLASSIFICATIONCLASSIFICATION p class I: eg throat swabs p class IIa: eg active devices p class IIb: eg implantables p class III: CNS, CVS contact p active implantables: eg pacemakers p class I: eg throat swabs p class IIa: eg active devices p class IIb: eg implantables p class III: CNS, CVS contact p active implantables: eg pacemakers

13. COMPETENT AUTHORITY p negotiate, implement p manage clinical investigation system p appoint, audit notified bodies p register, audit class I manufacturers p manage Vigilance system p enforce (including Safeguard action) p negotiate, implement p manage clinical investigation system p appoint, audit notified bodies p register, audit class I manufacturers p manage Vigilance system p enforce (including Safeguard action)