Transcript 4-4a EU device specific vigilance guidance

Safeguarding public health
Vigilance guidance for specific devices
Tony Sant/Andy Crosbie – MHRA
Presentation to the closed session of the Expert Group on Vigilance for Medical Devices – 15 Nov 2012
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Background
 MHRA has for some years issued advice on vigilance
reporting for specific types of devices.
 Guidance is aimed at manufacturers and gives advice on
notifying the MHRA of adverse incidents involving specific
types of CE-marked medical devices under the medical
devices vigilance system.
 Guidance is intended to facilitate uniform application and
implementation of Medical Devices Directive 93/42/EEC. It
is supplementary to (and should be read in conjunction
with) the latest version of European Commission Guidelines
on the Medical Devices Vigilance System - MEDDEV 2.12-1
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UK device specific vigilance guidance
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VG 01
VG 02
VG 03
VG 04
VG 05
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VG 06
VG 07
VG 08
VG 09
Joint replacement implants
- July 2010
Artificial heart valves
- Nov 2008
Breast implants
- Oct 2009
Coronary stents
- Mar 2009
IVD blood glucose meters for POCT or home use
- Dec 2008
Inferior vena cava (IVC) filters
- Mar 2009
Intra-ocular lenses
- Jun 2009
Neurostimulators
- Dec 2009
Cardiac Ablation Catheters
- July 2010
See:
http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devices/
Vigilanceguidanceforspecificdevices/index.htm
© Crown copyright 2009
What do the device specific vigilance
guidance documents do?
 They provide technical / clinical detail to supplement the
general guidance on vigilance reporting given in MEDDEV
2.12-1
 Each MHRA guidance document lists the major recognised
types of adverse incident associated with each specific type
of medical device and then gives MHRA’s opinion on
whether it is or is not usually reportable under vigilance as a
“malfunction or deterioration in the characteristics and/or
performance of the device”
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Summary table (see VG 06) of reportable/nonreportable individual adverse incidents under the
vigilance system for inferior vena cava filters
Note – for illustrative purposes only, this is not an exhaustive list
Reportable
Generally non-reportable
•Complications during deployment and
•Vascular access and device placement
placement
•Perforation/erosion
•Partial or multiple fractures
•Device migration
•Progressive tilting/angulation
•Recurrent/fatal pulmonary embolism
•Retrieval difficulties
•Labelling deficiencies
•MRI induced events
•Unanticipated events
related problems
•Inferior vena cava thrombosis/occlusion
•Endothelialisation
•IVC wall penetration
•Infection
•Adverse reaction
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Periodic summary reporting and trend reports
 MEDDEV 2.12-1 includes provision for manufacturers to
undertake periodic summary reporting and to submit trend
reports to national competent authorities
 Device specific vigilance guidance can be used to provide
guidance on types of adverse incidents which may be
suitable for these types of reporting (see for example VG 04
on coronary stents)
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Why should European device specific vigilance
guidance be developed?
 Device specific vigilance guidance would
• supplement the general guidance in MEDDEV 2.12-1 on a Europewide basis
• Improve co-ordination of advice to industry and prepare for
centralised reporting
• Harmonise use of PSRs and Trend reports in specific areas
 Minimise effort by concentrating on the lists of incident types to report
and not to report and when to use Trend and PSR reports
 The Commission and Member States are expected to improve coordination (Dalli immediate action plan)
 Now that the MD Regulations have been proposed (Sept 2012) a simple
programme of development could begin
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Next steps
Propose
 Vigilance MDEG discusses and agrees 1 or 2 device
specific guidance documents per meeting
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Safeguarding public health
Thanks for listening
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