Directive 94/9/EC: Guidelines on the application
Annex XI of Directive 94/9/EC defines the criteria that these bodies must fulfil. Bodies which are able to provide proof of their conformity with Annex XI by presenting to their Competent Authorities a certificate of accreditation and evidence that all additional requirements have been met or other means of documentary proof as defined below, are considered notifiable and in this respect they conform to Annex XI of the directive. The appropriate (voluntary) harmonised standards provide useful and appropriate mechanisms towards presumption of conformity to Annex XI. However, this does not rule out the possibility that bodies not conforming to the harmonised standards may be notified, on the grounds that compliance is obligatory only with respect to the criteria set out in Annex XI to the Directive.
Bodies provide the professional and independent judgements, which consequently enable manufacturers or their authorised representatives to fulfil the procedures in order to presume conformity to directive 94/9/EC. Their intervention is required:
- for issuing of EC-type examination certificates, and for inspection, verification and testing of equipment, protective systems, devices and components before they can be placed on the market and/or put into service;
- for the assessment of manufacturer's quality assurance system in the production phase.
The bodies responsible for undertaking the work referred to in Article 8 of the directive must be notified by the Member State under whose jurisdiction they fall, on their own responsibility to the Commission and the other Member States of the EU. This notification also includes the relevant scope of competence for which that body has been assessed as technically competent to certify against the Essential Health and Safety Requirements as shown in the directive. For the Member States of the EU, this responsibility of notification involves the obligation to ensure that the Bodies permanently maintain the technical competence required by directive 94/9/EC and that they keep their notifying authorities informed about the performance of their tasks.
Therefore, a Member State of the EU, which does not have a technically competent body under its jurisdiction to notify, is not required to make such a notification. This means that a Member State of the EU which does not have such a body is not required to create one if it does not feel the need to do so. A manufacturer always has the choice of contacting any body with the appropriate scope of technical competence, which has been notified by a Member State.
On their own responsibility Member States reserve the right not to notify a body and to remove an appointment. In the latter circumstance the relevant Member States shall inform the Commission and all other Member States.
For further information concerning Bodies, e.g. responsibilities, conformity assessment, testing, inspection facilities and sub-contracting, please see the "Guide to the implementation of directives based on New Approach and Global Approach".
9.2. Co-ordination and Co-operation
All notified bodies are asked to participate in Notified Body co-ordination activities. The group of notified bodies established under directive 94/9/EC, the so called ExNBG, normally meets annually and is made up of representatives of notified bodies with observers from the Commission, manufacturers and users trade associations, standards making bodies and other invitees. Attendance at each meeting is by invitation and any party wishing to be considered should contact the Chairman of the Group either through the Commission or via a body of your country. The group is responsible for discussing issues of a technical nature to ensure that the technical provisions of the directive and harmonised standards are applied in a uniform way. The group issue clarification sheets where ambiguities exist in technical procedures and also issues technical guidance documents where less detailed specifications require amplification.
Clarification sheets and guidance documents are noted by the Standing Committee and published on the internet: ExNBG Clarification Sheets noted by the ATEX Standing Committee.
It has been agreed that Notified Body are to keep a register of any subcontracting to allow effective monitoring by the responsible member state in order to ensure activities are being conducted properly. The register is to be updated systematically. The register contains information about the name and location of the subcontractor, the nature and scope of work undertaken, the results of regular evaluations of the subcontractor, including evidence that details of tasks are monitored as well as evidence that the subcontractor is competent and maintains competence for the tasks specified and evidence that a direct private law contract exists.
A Notified Body may engage experts in support of its assessment activities but the experts' activities are to be controlled as if the expert were directly employed by the Notified Body under the same contractual obligations and operate within the Notified Body's own quality system.
The ExNBG has concurred that further (serial) sub-contracting by any sub-contractor is strictly prohibited.
Although assessment can be sub-contracted including assessment against the requirements of EHSR's the Notified Body remains entirely responsible for the whole operation and shall safeguard impartiality and operational integrity.
Procedures for reviewing and accepting the work of any sub-contractor will ensure that the sub-contractor has not offered or provided consultancy or advice to the manufacturer, supplier, authorised representative or their commercial competitor with respect to the design, construction, marketing or maintenance of the products which are the subject of the sub-contracted task.
9.4. Retention of documentation
Under Article 8.1 (b)(ii) of the ATEX Directive 94/9/EC the manufacturer is required to undertake the conformity procedure at Annex VIII and then:
"communicate the dossier provided for in Annex VIII, paragraph 3 to a body which shall acknowledge receipt of it as soon as possible and shall retain it".
Bodies notified for this procedure should be so according to Article 8.1 (b)(ii) and not to Annex VIII as this latter procedure does not involve a body.
This dossier is not returned to the manufacturer on request (but may be added to), and in general it is retained for a period of ten years following the last placing of the product onto the market. The intention is that market surveillance authorities in the different member states should be given access to this dossier, in cases where there is a need to investigate the design or manufacturing details of a particular product.
With respect to the media used, it is accepted that this dossier may be in electronic format so long as it is legible and "readable" over the period concerned.
9.5. Bodies having knowledge of faulty products* on the market
Also a body which gets knowledge of faulty products, but is neither engaged in the module for EC-Type examination nor in a module for surveillance of the manufacture, should take some action.
If there is no immediate danger, if after contact with the responsible Notified Body for EC-Type examination and with the Notified Body responsible for surveillance of the production of the faulty product no satisfactory solution after appropriate time is reached, the Notified Body should inform his own authorities in charge of market surveillance to initiate the adequate measures.
In the case of immediate danger, the body should inform his own authority in charge of market surveillance, the Notified Body for EC-type examination and the Notified Body for surveillance of the production without delay.
* see Note 1 of the Guidelines