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© Safeguarding public health Implementing Medical Device Regulation and Maintaining Patient Safety Name Nicola Lennard Date October 2011
Slide 2 Date Name Presentation title © EU Regulatory System compliance ERs safety, performance Notified Body quality systems design dossier clinical data (literature, C/I) accredit audit Competent Authority European market post market surveillance serious adverse events investigation action
Slide 3 Date Name Presentation title © Essential Requirements devices must be designed in such a way that…. “the they will not compromise the clinical condition or SAFETY of patients…..provided that any RISKS which may be associated with their use constitute acceptable RISKS when weighed against the benefits….” …..devices must achieve the performances intended by the manufacturer….. MDD: Annex 1
Slide 4 Date Name Presentation title © EU Regulatory System compliance ERs safety, performance Notified Body quality systems design dossier clinical data (literature, C/I) accredit audit Competent Authority European market post market surveillance serious adverse events investigation action
Slide 5 Date Name Presentation title © Adverse Incident Investigation Investigation of 10,280 reports received in 2010 resulted in the following actions:- 100 medical device alerts issued 129 notifications to authorities in EU member states 403 manufacturer field safety corrective actions 293 other manufacturer field actions 294 cases requiring the provision of advice on safer device use or improved staff training 730 manufacturer undertakings to improve designs, manufacturing processes and quality systems
Slide 6 Date Name Presentation title ©
Slide 7 Date Name Presentation title © Specific Safety Initiatives Surgical Diathermy Endometrial Ablation Endovascular Aneurysm Repair Vaginal Tapes MOM Hip Replacements
Slide 8 Date Name Presentation title © Causes of adverse incidents
Slide 9 Date Name Presentation title © Device Education
Slide 10 Date Name Presentation title © Specialist Webpages
Slide 11 Date Name Presentation title ©
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Slide 1 of 37 Robert Packard, Consultant Medical Device Directive (MDD) 93/42/EEC as modified by 2007/47/EC.
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