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© Crown copyright 2009 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
© Crown copyright 2009 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
© Crown copyright 2009 UK device specific vigilance guidance VG 01Joint replacement implants - July 2010 VG 02Artificial heart valves - Nov 2008 VG 03Breast implants - Oct 2009 VG 04Coronary stents - Mar 2009 VG 05IVD blood glucose meters for POCT or home use - Dec 2008 VG 06Inferior vena cava (IVC) filters- Mar 2009 VG 07Intra-ocular lenses- Jun 2009 VG 08Neurostimulators- Dec 2009 VG 09Cardiac 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 MHRAs 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
© Crown copyright 2009 Summary table (see VG 06) of reportable/non- reportable individual adverse incidents under the vigilance system for inferior vena cava filters Summary table (see VG 06) of reportable/non- reportable individual adverse incidents under the vigilance system for inferior vena cava filters Note – for illustrative purposes only, this is not an exhaustive list Reportable Complications during deployment and 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 Generally non-reportable Vascular access and device placement related problems Inferior vena cava thrombosis/occlusion Endothelialisation IVC wall penetration Infection Adverse reaction
© Crown copyright 2009 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)
© Crown copyright 2009 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 Europe- wide 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 co- ordination (Dalli immediate action plan) Now that the MD Regulations have been proposed (Sept 2012) a simple programme of development could begin
© Crown copyright 2009 Next steps Propose Vigilance MDEG discusses and agrees 1 or 2 device specific guidance documents per meeting
© Crown copyright 2009 Safeguarding public health Thanks for listening
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