Medical Devices Vigilance Print E-mail
The medical devices vigilance relates to the reporting of medical devices incidents, registration and evaluation, the adoption of appropriate measures in order to protect health and the transmission of these measures to the interested agents.


What ActioMed offers to our clients:

  • Implementation and maintenance of medical devices vigilance system
  • Advisory consulting
  • Integration of medical devices vigilante
  • Standard Operating Procedures
  • Adverse incidents management
s_vigilanciaIn January 2008 the new guidelines published by the EU on Medical Devices Vigilance System (MEDDEV 2.12-1 rev 5) to facilitate uniform application of the requirements described in the European Directives on Medical Devices came into force. ActioMed can review vigilance procedures and provide advice to follow the new Guideline.


Recently the Royal Decree 1591/2009, of 16 October was published in Spain to regulate medical devices and the Royal Decree 1616/2009, of 26 October, to regulate active implantable medical devices. The vigilance system are set out in both, in Article 32 and 28, respectively.


"The medical devices vigilance system is an essential element, receiving and evaluating adverse incidents and transmitting the measures of health protection to prevent its recurrence or their consequences. This Royal Decree establishes the obligations of manufacturers, users and others responsible for the reporting of adverse incidents to the system and its operation. "



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