European Authorized Representative Center

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Medical Device Directive 93/42/EEC CE Marking services

EAAR MEMBER

ISO 9001:2001

Steps to obtain CE Marking for your MDD product

Each Medical 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.

It is important to select your European Authorized Representative before choosing a Notified Body; Particularly in assisting you classifying your product before submission to the Notified Body and guiding you through the Manufacturer Responsibilities.

	Appoint Obelis European Authorized Representative Center (O.E.A.R.C.) as your "European Authorized Representative" within the EU.
	Obelis European Authorized Representative will assist you to identify all applicable EU Directives (laws) for your product.
	Obelis European Authorized Representative will guide you in determining the applicable Standards - European, International or National.
	Obelis European Authorized Representative assists in assessing your product according to the "essential requirements" in the Directives. Article 11 of the MDD describes the available conformity assessment routes, and detailed information on the assessment "modules" are given in Annexes II.VII of the MDD.
	Obelis European Authorized Representative can direct you to identify the appropriate conformity assessment module 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 (MDD 93/42/EEC Annex VII).
	Obelis European Authorized Representative will guide you in how to implement and operate a "Quality Assurance System" as required in Section 3 of Annex II.
	Obelis European Authorized Representative will assist you, if required, in selecting a "Notified Body" within the EU Territory, to perform the official conformity assessment tasks.
	You must 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.)

For important Manufacturer's Obligations, see our article entitled "The Role of Non-European Manufacturers"

Medical Device Directive 93/42/EEC CE Marking services

Steps to obtain CE Marking for your MDD product

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

Obelis European Authorized Representative will assist you to identify

Obelis European Authorized Representative will guide you in determining the applicable

Obelis European Authorized Representative assists in assessing your product

Obelis European Authorized Representative can direct you to identify the appropriate

Obelis European Authorized Representative will assist you to prepare a "Technical File"

Obelis European Authorized Representative will guide you in how to implement and operate a "Quality Assurance System"

Obelis European Authorized Representative will assist you, if required, in selecting a "Notified Body"

You must assemble the required approvals and certificates and prepare a "EC Declaration of Conformity"