Early Implementation of an EU Vigilance Portal

The Medicines and Healthcare Products Regulatory Agency (MHRA) regulates medicines and medical devices in the UK. Together with other National Authorities, they started a pilot project on the implementation of an EU vigilance reporting portal for medical devices.

The project aims to create an EU centralized database to collect all vigilance reports from all EU Countries, using the information held to determine the appropriate distribution and in the format the MS requires. Thus one single portal can be used for initial, follow-up and final reports, Field Safety Corrective Actions (FSCA), Pre-Sentence Report (PSR) and Trend reports.


In February 2012 the European Commission urged Member States to improve the functioning of the vigilance system for medical devices:

  • Notified bodies should have access to incident reports so that they can assess their impact on the certificates they have issued;
  • A more co-ordinated analysis of adverse incidents reported by Member States, so that EU-wide problems can be detected and addressed more quickly;
  • Health Ministers to ensure that healthcare professionals do in fact report adverse events and to empower the patients to do so as well. We cannot only rely on the reporting by manufacturers.

The legal basis for this Vigilance Database is Article 14 of the MDD Directive 93/42/EEC, which foresees the creation of “… a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well informed basis.”

(Source: MD Expert Group on Vigilance – presentation)

The benefits of a unified EU portal

  • Allowing manufacturers to submit their report to CAs is a more efficient means of meeting existing reporting obligations;
  • Giving appropriate access to Notified Bodies will remove double reporting for manufacturers;
  • A central database gives CAs similar levels of access to vigilance data as manufacturers and NBs;
  • Development of centralised data analysis tools is good for protecting public health and financially sensible for the EU public purse.

National Authorities participants to the pilot project

  • MHRA – United Kingdom
  • BfARM – Germany Federal Authority
  • ANSM – French Authority
  • JRC – Joint Research Council – European Commission

Obelis provides European Authorized Representative (EC REP) services to manufacturers worldwide (EU & Non-EU), all in accordance with European Directives & Regulations. Our services include incident reporting and complaint handling.

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