Non European Medical Device Manufacturers

The MDD 93/42/EEC Medical Device Directive, mandatory since June 14,1998 requires Non-European Medical Device Manufacturers to appoint a European Authorized Representative to sell their product in Europe .(MDD 93/42 Article 14) Obelis (O.E.A.R.C.) is the foremost Authorized Representative for your Medical Devices.

Services for Class I Medical Device Products

We provide full CLASS I CE-Marking approval services. We assist you with the preparation of the Technical File, preparation and submission of the Notification File to be approved by the European Competent Authorities. (MDD 93/42, art.11,8) Obelis European Authorized Representative becomes your independent representative towards the Competent Authorities, Notified Body, distributors and European users. We present the notification form for CLASS I Medical Devices to be introduced in the EU market. (MDD 93/42, art.14) Obelis European Authorized Representative provides the address on the product related printing materials, i.e. catalog, instruction sheets, packaging, manuals. (MDD 93/42, Annex I, B, 13.3) Obelis European Authorized Representative holds the product’s Technical File available for the EU Competent Authorities Review (MDD 98/42 Annex II, 3.2).
O.E.A.R.C. offers the following free services:

Identification of product classification
Identification of the appropriate notified body
Coordination between the manufacturer and the notified body
Use of Obelis’ office (with 10 days notice)

YOU DON’T NEED NOTIFIED BODY SERVICES FOR CLASS I PRODUCTS

Services for Class IIa, IIb, III Medical Device Products

We provide full Authorized Representative services for CLASS IIa, IIb & III products. Obelis European Authorized Representative becomes the manufacturer’s independent representative towards the Competent Authorities, Notified Body, Distributors and European users. Obelis European Authorized Representative provides the address on the product related printing materials i.e. catalog, instruction sheets, packaging, manuals. (MDD 93/42 Annex I, B 13.3) Obelis European Authorized Representative holds the product’s Technical File available for the EU Competent Authorities Review (MDD 98/42,Annex II, 3.2).
Obelis European Authorized Representative offers the following free services: