Steps to obtain CE Marking for your IVD product

Each In Vitro Device Manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis (O.E.A.R.C.) for steps tailored to your company. The following are general steps to obtain CE Marking.

Appoint Obelis European Authorized Representative Center (O.E.A.R.C.) as your “European Authorized Representative” within the EU.

• Obelis European Authorized Representative determines the applicable Standards: European, International or National.
• Obelis European Authorized Representative will identify the appropriate conformity assessment module according to your product classification.
• Obelis European Authorized Representative assist in assessing your product according to the “essential requirements” in the Directives. Article I of the IVDD describes the available conformity assessment routes available to manufacturers depending on the risk category of the product.
• Obelis European Authorized Representative will identify the appropriate conformity assessment route according to your product classification.
• Obelis European Authorized Representative will assist you to prepare a “Technical File” including a user manual, as outlined in the Directive (IVDD 98/79/EC Annex III section 3).
• Obelis European Authorized Representative will indicate how to implement and operate a “Quality Assurance System” as required in Section 4 of Annex III.
• Obelis European Authorized Representative will assist you, if required by your product type, in selecting a “Notified Body” within the EU Territory, to perform the official conformity assessment tasks.
• Obelis European Authorized Representative help assemble the required approvals and certificates and prepare a “EC Declaration of Conformity” per product according to the applicable Directives. (Note that the Declarations of Conformity and Technical Files can be written in English.)
• Obelis European Authorized Representative indicate how you affix the CE Marking in accordance with the Directive (the format of the CE Marking and its proper location is described in Directive 93/68/EEC, dated July 22, 1993).

For important Manufacturer’s Obligations, see our article entitled “The Role of Non-European Manufacturers”

Last updated Nov 10, 2008

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