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To our customers in the European Union:
The In-Vitro Diagnostics Directive (98/79/EC) (IVDD) was recently introduced in the EU as the third in a series of Medical Device Directives. It came into force on December 7th 2003.
References:
A Quick Guide to CE Marking
View CE Marking/IVD Symbols
Anatomical Pathology IVD Product Flow Diagram for Histology and Cytology Workflow
The IVDD defines an in vitro diagnostic medical device as follows: ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
- concerning a physiological or pathological state,or
- concerning a congenital abnormality, or
- to determine the safety and compatibility with potential recipients, or
- to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
As you know, a significant proportion of our product range is used in the histological and cytological preparation of human samples to aid in the efficient final diagnosis. For this reason, we feel very strongly that it is in the interests of our customers that the products used directly for the preparation of samples (including such products as tissue processors, cytocentrifuges, stainers, microtomes and cryotomes, and their accessories) should meet the IVDD.
We are therefore pleased to announce that Thermo Fisher Scientific can certify that all of our relevant Anatomical Pathology products meet the In Vitro Diagnostics Directive.
As an ISO9001:2000 company, we are continually audited to make sure we comply with this International Quality Standard and are committed to deliver a product that has undergone a rigorous internal quality control process.
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