These documents are aimed at manufacturers and give advice on notifying the MHRA of adverse incidents involving CE-marked medical devices under the medical devices vigilance system.
The devices covered are:
- artificial heart valves
- breast implants
- cardiac ablation catheters
- coronary stents
- inferior vena cava filters
- intraocular lenses
- IVD blood glucose meters used in POCT/home
- joint replacement implants
- neurostimulators.
General information on the vigilance system can be found in our Bulletin No 3 - Guidance on the operation of the EU vigilance system in the UK.
Latest vigilance guidance
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05 Jul 2010 | Cardiac ablation catheters - guidance on the vigilance system (VG09)
This document gives advice to manufacturers on the notification of adverse incidents involving cardiac ablation catheters under the medical devices vigilance system.
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08 Dec 2009 | Neurostimulators - guidance on the vigilance system (VG08)
This document gives advice to manufacturers on the notification of adverse incidents involving neurostimulators under the medical devices vigilance system.
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23 Oct 2009 | Breast implants - guidance on the vigilance system (VG03)
This document gives advice to manufacturers on the notification of adverse incidents involving CE marked devices under the medical devices vigilance system.
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05 Jun 2009 | Intraocular lenses - guidance on the vigilance system (VG07)
This guidance document provides advice to manufacturers on the notification of adverse incidents involving intraocular lenses (IOLs) under the medical devices vigilance system.
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18 Mar 2009 | Coronary stents - guidance on the vigilance system (VG04)
Advice for manufacturers on the notification of adverse incidents involving CE marked devices under the medical device vigilance system.
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11 Mar 2009 | Inferior vena cava (IVC) filters - guidance on the vigilance system (VG06)
This document gives advice to manufacturers on the notification of adverse incidents involving CE marked devices under the medical devices vigilance system.
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11 Nov 2008 | Artificial heart valves - guidance on the vigilance system (VG02)
This document gives advice to manufacturers on the notification of adverse incidents involving CE marked devices under the medical devices vigilance system.
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11 Nov 2008 | IVD blood glucose meters in POCT or home use - guidance on the vigilance system (VG05)
This document gives advice to manufacturers on the notification of adverse incidents involving CE marked devices under the medical devices vigilance system.
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17 Jun 2008 | Joint replacement implants - guidance on the vigilance system (VG01)
This document gives advice to manufacturers on the notification of adverse incidents involving joint replacement implants under the medical devices vigilance system.
