ATLA::Alternatives to Laboratory Animals

Volume 23, Number 4

Biological evaluation of medical devices: a review of EU regulations, with emphasis on in vitro screening for biocompatibility.

ATLA 23, 469-473, July/August 1995

Gottfried Schmalz

Department of Operative Dentistry and Periodontology, University of Regensburg, 93042 Regensburg, Germany

SUMMARY

The quality of medical devices (including their biocompatibility) is regulated throughout the European Economic Area by Directive 93/42/EEC, which came into effect on 1 January 1995. The CE (conformity assessment) mark placed on the device shows conformity with the essential requirements, which guarantee the desired level of quality. Standards can be used to prove this conformity with the essential requirements. Scientific input is needed to produce and update relevant standards.

Keywords: medical device, cell culture, dentistry, standards, European Union