11/08/2011

Obelis O.E.A.R.C.

Notified Bodies & EC REP – Complementary Activities towards the CE Marking

The CE marking is a European mark, under European law (Directives & Regulations) and as such aimed at European entities only (!) – in order to place a product within the European market, conformity with the requirements needs to be demonstrated, the CE marking affixed and a registered address within the European Community established.

As such, a Non-EU manufacturer (not having a registered address in the EU) will be required in some cases (dependent on the product classification in reference to the applicable Directive) to nominate two separate entities in order to obtain the CE marking:

1. A European Notified Body (NB) – In some cases.
2. A European Authorized Representative (EC REP) – Always (!).

By EU Law, one cannot fulfill the other’s obligations and each of the above must be nominated separately.


Notified Body Role:

Supports the manufacturer to bring his product to the market by:
1. Carrying out conformity assessments
2. Issuing certificates
3. Performing surveillance audits

(*) A NB may not provide consultation!


Authorized Representative Role:

Supports the manufacturer to bring his product to the market by:
1. Provides a Registered Address in the EU – as such validating the CE certificate
2. Keeps the Technical Documentation available in Europe for inspection by the EU Authorities
3. Completes Notification to the EU Authorities
4. Completes (any) Device Registration to National Databases (e.g. Italy, Portugal, France)
5. Takes care of (any) incident reporting
6. Represents towards Commission, Authorities & NB
7. Safeguards the compliance – Regulatory Updates!
8. Acts as Consultant on EU Regulation!

(*) The EC REP is the one to provide consultation at all times!

Obelis operates as one of the largest regulatory centers in Europe today, providing CE marking advisory services and Authorized Representative (EC REP) services. As part of our Authorized Representative services, we help our clients to find the best solutions to their needs, including the selection of a Notified Body.

Visit www.obelis.net for more information!