Notified Body

The Finnish Communications Regulatory Authority (FICORA) will close notified body (No. 0523) operations as referred to in Annexes III and IV of the R&TTE Directive on 31.12.2008. There are two new notified bodies nominated: Nemko Oy and SGS Fimko Oy.

The notified body is responsible for 'third party inspections', more precisely defined in the R&TTE Directive. The following procedures are connected with the use of a notified body:

a) Internal production control plus specific apparatus tests (Annex III)
This procedure is applied if all essential radio test suites are not defined in the harmonised standard for the equipment concerned. In these cases the test suites needed for conformity assessment are defined by the notified body.

b) Technical construction file, TCF (Annex IV)
This procedure is applied if harmonised standards for the equipment do not exist or if the manufacturer has chosen not to use them. In these cases the notified body defines the test suites, inspects the technical construction file established by the manufacturer and issues an opinion on the conformity with essential requirements of the equipment.

In both procedures the manufacturer finally prepares a written declaration of conformity (DoC) and provides the equipment with the CE marking and the identification number of the notified body. The equipment must also bear the alert symbol if its use is restricted in some Member State.

An opinion by the notified body is valid in all EEA Member States. The inspection is chargeable. The documentation between the notified body and the manufacturer relating to the conformity assessment is confidential.

The standards needed in the conformity assessment are prepared by ETSI and Cenelec. There are harmonised standards concerning the article 3.2 of R&TTE Directive for most products. For new applications standardization may take several years. Manufacturers of new applications which do not have harmonised standard yet have to follow the procedure defined in Annex IV and obtain an opinion of a notified body.