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1. INTRODUCTION
1.1.1 These Guidelines describe a system for the notification and evaluation of adverse incidents to be known as the Medical Devices Vigilance system. They are intended to facilitate the uniform application and implementation of the Directive for Active Implantable Medical Devices (AIMD) and the Directive for Medical Devices (MDD). In particular, Article 8 (AIMD) and Article 10 (MDD) outline the obligations of Member States upon receipt of incident reports, from manufacturers or other sources, concerning any medical device which carries the CE
marking
These Guidelines also give guidance on those Annexes of the Directives which oblige the manufacturer to report certain types of incident to Competent Authorities.
These Guidelines are not enforceable by law.
Relevant extracts from both Directives are provided in Appendix 7.
A diagrammatic summary of the system is given in Appendix 9.
1.1.2 These Guidelines cover the activities of :
- the Commission,
- Competent Authorities,
- Notified Bodies,
- manufacturers (including their authorised representatives and persons responsible for placing on the market, see Article 14 of the MDD),
- users and others concerned with the continuing safety of medical devices.
For the purposes of Medical Devices Vigilance, Member States are represented by the Competent Authorities listed in Appendix 1.
1.1.3 These Guidelines cover the action to be taken once the manufacturer or Competent Authority receives information concerning an incident. Information on incidents which should be reported under the Vigilance system may come to the attention of manufacturers via the systematic procedure to review experience gained from devices in the post-production phase, or by other means (see Annexes 2, 4, 5, 6, 7 of MDD). The term "post-marketing surveillance" as referred to in Annex 2, 4, 5 in AIMD has the same meaning as the aforementioned "systematic procedure..".
These Guidelines make no recommendations on the structure of the systems by which manufacturers gather information concerning the use of devices in the post-production phase.
1.1.4 This medical devices vigilance system takes precedence over information systems to be installed under the requirements of the Council Directive 92/59/EEC of 29/6/1992 on General Product Safety(1)
1.2 USER AND OTHER INCIDENT REPORTING SYSTEMS
1.2.1 Member States may wish to supplement reports received from manufacturers under the Vigilance system with reporting from other sources. Member States should adopt administrative measures to ensure that the pertinent manufacturers are informed without delay of reports meeting the criteria set out later in these Guidelines (see para 6.4).
1.2.2 In order to enhance the efficacy of the Medical Device Vigilance system, Competent Authorities should encourage the reporting of adverse events by the user. Such reports may be made either directly to the Competent Authority, or to the manufacturer, or to both depending on National practice.
1.3 APPLICABILITY
1.3.1 These Guidelines refer to incidents occurring within the Member States of the European Community and all other States within the European Economic Area (EEA) with regard to:
* devices which carry the
and
* devices which do not carry the
Corrective action includes, but may not be confined to: device recall; issue of advisory notice; additional surveillance/modification of devices in use; modification to future device design, components or manufacturing process; modification to labelling or instructions for use.
These Guidelines do not apply to devices under clinical evaluation or investigation - see Annex 7 of AIMD and Annex 10 of MDD.
1.3.2 If incidents which occur outside the EEA lead to corrective action relevant to
1.3.3 These Guidelines are intended to be applicable equally to the Directive for Active Implantable Medical Devices and the Medical Devices Directive. The procedures are intended to be the same for both Directives, with respect to the Vigilance system.
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