Regulations 2, 13 and 20
1. EC verification is the procedure whereby a notified body checks and certifies, at the request of a contracting entity or its authorised representative established within the Community, that a subsystem:
complies with the Directive;
complies with the other regulations deriving from the Treaty and may be put into operation.
2. The subsystem is checked at each of the following stages:
overall design;
structure of subsystem, including, in particular, civil-engineering activities, constituent assembly, overall adjustment;
final testing of the subsystem.
3. The notified body responsible for EC verification draws up the certificate of conformity intended for the contracting entity or its authorised representative established within the Community, which in turn draws up the EC verification declaration intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.
4. The technical record accompanying the verification statement must be made up as follows:
for infrastructures: engineering-structure plans, approval records for excavations and reinforcement, testing and inspection reports on concrete;
for other subsystems: general and detailed drawings in line with execution, electrical and hydraulic diagrams, control-circuit diagrams, descriptions of data-processing and automatic systems, operating and maintenance manuals, etc.;
list of interoperability constituents, as referred to in Article 3, incorporated into the subsystem;
copies of the EC declarations of conformity or suitability for use with which said constituents must be provided in accordance with Article 13 of the Directive, accompanied where appropriate by the corresponding calculation notes and a copy of the records of the tests and examinations carried out by the notified bodies on the basis of the common technical specifications;
certificate from the notified body responsible for EC verification, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with this Directive and mentioning, where appropriate, reservations recorded during performance of the activities and not withdrawn; the certificate should also be accompanied by the inspection and audit reports drawn up in connection with the verification, as specified in points 5.3 and 5.4.
5. Monitoring
5.1 The aim of EC monitoring is to ensure that the obligations deriving from the technical record have been met during production of the subsystem.
5.2 The notified body responsible for checking production must have permanent access to building sites, production workshops, storage areas and, where appropriate, prefabrication or testing facilities and, more generally, to all premises which it considers necessary for its task. The contracting entity or its authorised representative within the Community must send it or have sent to it all the documents needed for that purpose and in particular the implementation plans and technical records concerning the subsystem.
5.3 The body notified responsible for checking implementation must periodically carry out audits in order to confirm compliance with the Directive. It must provide those responsible for implementation with an audit report. It may require to be present at certain stages of the building operations.
5.4 In addition, the notified body may pay unexpected visits to the worksite or to the production workshops. At the time of such visits the notified body may conduct complete or partial “audits”. It must provide those responsible for implementation with an inspection report and, if appropriate, an audit report.
6. The complete record referred to in paragraph 4 must be lodged with the contracting entity or its authorised agent established within the Community in support of the certificate of conformity issued by the notified body responsible for checking the subsystem in working order. The record must be attached to the EC declaration of verification which the contracting entity sends to the supervisory authority in the Member State concerned.
A copy of the record must be kept by the contracting entity throughout the service life of the subsystem. It must be sent to any other Member States who so request.
7. Each body must periodically pass on relevant information concerning the following:
requests for EC verification received;
certificates of conformity issued;
certificates of conformity refused.
8. The records and correspondence relating to the EC verification procedures must be written in an official language of the Member State in which the contracting entity or its authorised representative is established within the Community, or in a language accepted by the Community.