The directive and the relevant Regulation describe four procedures for conformity assessment, one of which must be used to demonstrate compliance with all the relevant essential requirements, subject to an alternative for the EMC and LVD essential requirements. These are described in Annexes II, III, IV and V of the directive and the relevant Regulation. As an alternative for compliance with the essential requirements in respect of Article 3(1)(a) Safety and 3(1)(b) EMC, the procedures in 73/23/EEC and 89/336/EEC may be used respectively for those aspects, for apparatus within the scope of those directives. The alternative means of demonstrating compliance are contained within those directives.
Annex II - Internal production control
The manufacturer must establish technical documentation that enables the conformity of the product with the essential requirements to be assessed. This must cover the design, manufacture and operation of the product and include:
- a general description of the product
- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
- descriptions and explanations necessary for the understanding of the understanding of the above and the operation of the product
- a list of standards applied in full or in part and description of the solutions adopted to meet the essential requirements where they have not been applied in full
- the results of design calculations made, examinations carried out, etc.
- test reports
The manufacturer must take all measures necessary to ensure that the apparatus complies with the documentation and with the requirements of the directive. They, or their authorised representative, must keep a copy of the declaration of conformity with the technical documentation.
Annex III- Internal production of Control plus specific apparatus
The requirements of Annex II apply, along with the following.
For each type of apparatus, all essential radio test suites must be carried out by the manufacturer, or on his behalf. The essential test suites may be described in the harmonised standards. Where they are not, they must be identified by a Notified Body chosen by the manufacturer.
Annex IV – Technical Construction File
The technical documentation described in Annex II, and the declaration of conformity to the specific radio test suites described in Annex III, form a technical construction file, which must be presented to a Notified Body for review. The file may be presented to more than one body, provided each is informed of the others who have received a copy of the file.
The Notified Body reviews the file, and if not satisfied that it demonstrates that the essential requirements have been met, must inform any other Notified Bodies involved, and may also inform the manufacturer, their authorised representative or the organisation responsible for placing the apparatus on the market. The opinion must be delivered within four weeks of receipt of the file.
On receipt of the opinion, or at the end of the four-week period, the apparatus may be placed on the market.
The manufacturer, their authorised representative or the organisation responsible for placing the apparatus on the market, must keep the file for not less than ten years after last apparatus has been manufactured.
Annex V – Full Quality Assurance
The manufacturer must operate an approved quality system for design, manufacture and final product inspection and testing, subject to surveillance by a Notified Body at “reasonable” intervals and, possibly, unexpected visits. The annex contains details of the processes involved. The Notified Body must assess whether the system ensures the conformity of the products, and the manufacturer must undertake to fulfil the requirements of the system.
It is important to note that whatever route is chosen, the manufacturer has the responsibility to ensure that their product complies. Notified Bodies only issue opinions, and have no power to prohibit the placing on the market of any product, even under the TCF route.
Declaration of Conformity
The declaration of conformity is drawn up by the manufacturer, or if he so chooses, his authorised representative. The manufacturer does not have to be based in the EEA, and the declaration is valid wherever it is drawn up.
If the manufacturer is not based in the EEA and does not appoint an authorised representative within the EEA, the obligation to keep the declaration of conformity falls on the person who places the apparatus on the EEA market. Such persons will need (for their own benefit) to ensure that they hold this document. If the apparatus is also covered by other directives then one declaration of conformity is sufficient provided all the information required by each directive is included. Equally, one declaration of conformity may be produced for each directive.
A copy of the declaration of conformity must accompany every product.