Vig­i­lance of In Vit­ro Di­ag­nos­tics (IVD)

The PEI is responsible for the evaluation of the technical and medical requirements and the safety of in vitro diagnostic medical devices, as laid down in Article 32 of the German Medical Devices Act (MPG), which are intended for testing the safety or compatibility of blood or tissue donations or are related to infectious diseases.

This concerns reagents and reagent products, including related calibrators and control materials, related to the following:

Infection parameters:

  • HIV 1 + HIV 2
  • hepatitis B
  • hepatitis C
  • hepatitis D
  • rubella
  • toxoplasmosis
  • cytomegalovirus
  • chlamydia

Blood and tissue parameters

  • blood groups of the ABO system
  • rhesus (C, c, D, E, e)
  • anti-Kell,
  • anti-Duffy
  • anti-Kidd
  • irregular anti-erythrocytic antibodies
  • HLA tissue groups DR, A, B.

The MPG, Article 29, governs the competence of the competent federal authority regarding the central collection, analysis and evaluation of the risks arising from the use or application of medical devices. This includes, in particular, adverse effects, contra-indications, falsifications, and technical defects.

The reporting obligation by the responsible party is laid down in the Ordinance on the Medical Devices Vigilance System (MPSV), Article 3. In addition to collecting and evaluating incidents reports, the PEI also coordinates necessary measures due to serious adverse events, operational problems, performance changes or failures, or due to the systematic recall of medical devices of the same type for technical or medical reasons. The surveillance of in vitro diagnostic medical devices contributes to a high level of safety of blood-derived medicinal products.

Updated: 21.11.2019