CPR 305/2011/EU Services

Authorized Representative tasks under CPR 305/2011/EU:
CPR 305/2011/EU Article 12 point 2;

“An authorized representative shall perform the tasks specified in the mandate. The mandate shall allow the authorized representative to carry out at least the following tasks:

(a) Keep the declaration of performance and the technical documentation at the disposal of national surveillance authorities for the period referred to in Article 11(2);

(b) Further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the construction product with the declaration of performance and compliance with other applicable requirements in this Regulation;

(c) Cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by construction products covered by the mandate of the authorized representative”.

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community;
Guidance on Declaration of Performance release;
Market incident reporting and complaint handling coordination (CPR 305/2011/EU);
Product labeling compliance: European Authorized Representative address on the product related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (CPR 305/2011/EU);
Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked product is properly put on the European market.

Advisory services

Ongoing language maintenance and glossary development (for over 40 different languages);
Device listing and registration according to European member state national requirements;
Technical File documentation review;
Guidance on QMS implementation;
Guidance on product safety consultancy;
Guidance on product testing and certification services.

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services