Obelis European Authorized Representative Center (O.E.A.R.C.)
CE Marking Made Simple
CE Marking Made Simple
To obtain a CE mark, 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 and read below for some information about what this program involves.
The next step of the CE marking process is to choose a Notified Body. Before choosing a Notified Body, it is important that you select your European Authorized Representative. Your European Authorized Representative can particularly assist you in classifying your product before submission to the Notified Body and can also guide you through the Manufacturer Responsibilities.
Appointing Obelis European Authorized Representative Center (O.E.A.R.C.) as your "European Authorized Representative" within the EU will make your endeavors into European markets simple and successful.
Obelis European Authorized Representative will provide you with a CE mark by first creating your personal compliance program through the following steps:
Assist you to identify all applicable EU Directives (laws) for your product
Guide you in determining the applicable Standards - European, International or National
Assist you 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
Direct you on how to identify the appropriate conformity assessment module according to your product classification
Assist you to prepare a "Technical File", including a user manual, as outlined in the Directive (MDD 93/42/EEC Annex VII)
Guide you in how to implement and operate a "Quality Assurance System"as required in Section 3 of Annex II
Assist you, if required, in selecting a "Notified Body" within the EU Territory, to perform the official conformity assessment tasks
To obtain your CE mark, all you must do is:
Assemble the required approvals and certificates
Prepare an "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 assistance with either of these tasks, contact Obelis European Authorized Representative Center (O.E.A.R.C.) today.
Please visit Obelis, s.a. at Medica 2005 in Hall #13, Booth #A14.