Update of Vigilance Guideline published
In January the updated vigilance guideline MEDDEV 2.12 -1 rev. 8 for medical devices was published. This guideline is available only in English and is a consensual document for the collective whole of the various Competent European Authorities, the industry and other interested parties but without legal status.
Due to the involvement of relevant interested parties including the Authorities, is the guideline considered the recognized standard for the vigilance system within the European Union.
National legal requirements are in place in the various countries and in comparing the MEDDEV for example with the German national vigilance requirements (Medizinprodukte-Sicherheitsplanverordnung), it is noted that the guideline provides detailed criteria and examples in regards to the determination whether an event is considered an incident, which must be reported. In regards to the implementation of Field Safety Corrective Action (FSCA) important information is given. Please note that German law specifically calls out that the Field Safety Notices (FSN) must be provided in German, as it is required in other countries to report in local languages.
Most certainly the legal provisions of each country apply but MDSS so far with being involved with all European Authorities for vigilance has not encountered any difficulties if the MEDDEV is being followed. It is our opinion that the MEDDEV does concur with the national laws in place.
The published January version has been broadened. Significant clarifications now have been given for products, which may indirectly harm a patient. This applies in particular for the in-vitro diagnostics and products for vitro fertilization (IVF/ART). However, software or diagnostic medical devices may be affected by these changes as well.
With the previous version from the middle of 2012 new reporting forms were provided, which streamline now trend reports and periodic summery reporting.
The guidelines can be downloaded under the following address: Guidelines