The European Commission intends to revise the legislation on in vitro diagnostic medical devices
In the context of the recast of the regulatory framework for medical devices and following a consultation in 2008, the European Commission has launched a public consultation on technical aspects related to the revision of Directive 98/79/EC on in vitro diagnostic (IVD) medical devices. It invites stakeholders to provide feedback with regard to the proposed options.
IVDs are used in the healthcare sector for the purpose of diagnostic, monitoring and prevention of a disease or a condition and provide information about a person's physiological or pathological state (e.g. pregnancy tests, blood glucose measurement, blood group determination). The current legislation was adopted in 1998. Since then IVDs have significantly evolved technologically. Also the broader regulatory landscape has changed in Europe and at international level.
The Commission considers it necessary to introduce (interalia) clearer definitions and requirements for safety and performance. This concerns in particular tests which are made and used within the same health institution ("in house tests"), regarding genetic tests or diagnostic services.
Interested parties such as manufacturers, users of IVDs, e.g. hospitals, test laboratories and consumers, as well as competent authorities and conformity assessment bodies are asked to provide feedback to the questions set out in the consultation document and to support their answers with data regarding the possible socio-economic impact of the proposed options. The consultation runs until 15 th of September 2010.
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