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Vigilance Experience for High-Risk IVDs in Europe

A comprehensive postmarketing information system is needed in Europe to ensure the safety of high-risk in vitro diagnostic devices, say Folker Spitzenberger, Rainer Edelhäuser, Markus Funk and Jochen Halbauer.

Dr Folker Spitzenberger is a quality assessor and scientist in the medical devices department of the ZLG, the German designating and notifying authority in the field of medical devices including in vitro diagnostic devices (IVDs). Dr Rainer Edelhäuser is quality assessor and head of the medical devices department of the ZLG and Dr Markus Funk and Dr Jochen Halbauer work in the IVD department of the Paul-Erhlich-Institut (PEI), as head of vigilance and scientific co-worker respectively. The PEI is responsible for high-risk devices (reagents and reagent products) related to infectious diseases and those for use in safety testing of blood or tissue donations.

Since December 2003, in vitro diagnostic devices (IVDs) have had to be placed on the European market according to the provisions of Directive 98/79/EC on in vitro diagnostic medical devices...

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