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Safeguarding public health

Implementing Medical Device Regulationand Maintaining Patient Safety

Name Nicola LennardDate October 2011

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EU Regulatory System

compliance ERssafety, performance Notified Body

• quality systems• design dossier• clinical data (literature, C/I)

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European market post market surveillance serious adverse events

investigation action

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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 performancesintended by the manufacturer…..

MDD: Annex 1

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EU Regulatory System

compliance ERssafety, performance Notified Body

• quality systems• design dossier• clinical data (literature, C/I)

accreditaudit

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European market post market surveillance serious adverse events

investigation action

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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

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Specific Safety Initiatives

•Surgical Diathermy

•Endometrial Ablation

•Endovascular Aneurysm Repair

•Vaginal Tapes

•MOM Hip Replacements

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Causes of adverse incidents

-

10

20

30

40

50

Healthcare establishmentor User responsibility

ManufacturerResponsibility

No established device oruse link

% o

f co

ncl

ud

ed

inve

stig

atio

ns

2008

2009

2010

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Device Education

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Specialist Webpages

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