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Hematology & Histology

CE Marking Policy

Sigma-Aldrich CE Marking Policy Statement (Directive 98/79/Ec of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices)

CE marking affects approximately 205 Hematology & Histology products manufactured by Sigma-Aldrich in St. Louis, U.S.A.

Sigma-Aldrich considers that the above products have been CE marked according to the IVD Directive and comply with the requirements therein in that:

  1. These products have been correctly classified as General IVDs and are self certified.
     
  2. The products meet the essential requirements as required in Annex 1 of the Directive.
     
  3. The relevant technical documentation has been prepared which details the manufacturing process and shows the principles of quality assurance have been followed.
     
  4. An EC Declaration of Conformity has been drawn up and signed as required by Section 1 (Annex III) of the Directive.
     
  5. The CE mark has been affixed to the product labels and IFUs where appropriate.
     
  6. Prior to marketing the product in a designated country, Sigma-Aldrich has registered these products with the Competent Authorities in that country of the EEA where there is a requirement to do so.

As the above products are classified as General IVDs and therefore low risk products, there are no certificates issued by the Competent Authorities which will show compliance with the Directive nor is there a requirement to obtain such certification.