General steps for TSD CE Marking

Each 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 product. It is important to select your European Authorized Representative before choosing an Approved Body (Notified Body); particularly to assist you in classifying your product before submission to the Notified Body and to guide you through the Manufacturers Responsibilities.

Appoint Obelis European Authorized Representative your Authorized Representative within the EU (TSD 88/378/EEC Article 8).

Obelis European Authorized Representative will identify all European regulations pertaining to your product (TSD 88/378/EEC Article 5.1).
Obelis European Authorized Representative determines applicable standards European, International or National (TSD 88/378/EEC Article 5.2).
Obelis European Authorized Representative Affixs the necessary warnings and precautions as outlined in Annex IV.
Select an “Approved Body” or “Notified Body” within the EU Territory, to perform the official conformity assessment tasks (TSD 88/378/EEC Article 8.2).
Assemble the required approvals and certificates (TSD 88/378/EEC Article 5.2).
Obelis European Authorized Representative will assist you in Preparing a “Technical File” to be kept available to the European Competent Authorities by the Authorized Representative established within the community (TSD 88/378/EEC Article 8.1.b).
Affix the CE Mark to the product affirming compliance (TSD 88/378/EEC 5.1)