GUIDE PPE - Cyprus Organization for the Promotion of Quality

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Guide on PPE Directive EuropeAid /114385/D/SV/CY placed on the market is not the job of the Notified Bodies responsible for evaluation of PPE models before they are placed on the market. However the public authorities do not always have the necessary expertise or equipment needed to carry out the very specific tests required to check the conformity of PPE with EHSRs. The public authorities may thus call on competent bodies, including the Notified Bodies, to provide this expertise, while remaining sole judge of the conclusions to be drawn and the action to be taken. Member States must designate the authorities responsible for enforcement, including market surveillance of PPE. They may be national, regional or local authorities, provided the whole national territory is covered. Market surveillance may also be shared between several authorities; indeed this may be necessary to cover both PPE for professional and private use for which distribution channels are often different. The authorities concerned may include the consumer protection services, labour inspection, and customs authorities. When Member States designate several authorities for market surveillance it is necessary to organise co-ordination of their activity. It is also useful to select a single co-ordinating authority, which may be the correspondent for the authorities of other Member States. These authorities must have the necessary powers and be attributed sufficient resources to be able to carry out effective market surveillance activity. These include the power to visit manufacturers’ distributors’ or users’ premises, to take or purchase samples for examination or for testing, and to require all necessary information. Market surveillance activity can take several forms. Schematically, it is possible to distinguish formal checks from checks on substantial, technical compliance with EHSRs. CHECKS ON MARKING AND DOCUMENTATION The directive provides the authorities responsible for market surveillance with a number of tools for checking compliance with the conformity evaluation procedures. Absence of CE marking is a clear indication that the requirements of the directive have not been taken into account. The manufacturers’ EC declaration of conformity must be produced on demand. This document enables market surveillance authorities to know which evaluation procedure has been followed, the notified body or bodies concerned, and the harmonized standard or standards used. The information contained in the EC declaration of conformity can be compared with the manufacturers’ instructions for use (which must accompany the PPE), to check that the evaluation procedure followed corresponds to the risks against which the PPE is designed to protect. The information contained in the EC declaration of conformity also enables the authorities to contact the Notified Bodies concerned in order to obtain a copy of the EC type-examination certificate, of the manufacturers’ technical file and of the test reports. Finally, the authorities may require the manufacturer to produce relevant extracts of the technical documentation in support of the EC conformity declaration. In many cases, examination of the marking and documentation may be considered a sufficient indication of the conformity of the PPE. However, in case of doubt as to the conformity of PPE with the EHSRs or
Guide on PPE Directive EuropeAid /114385/D/SV/CY with the performance levels claimed by the manufacturer, it is generally not possible to reach a conclusion simply by visual examination. Checking technical conformity of PPE requires carrying out laboratory tests. CHECKING COMPLIANCE WITH ESSENTIAL HEALTH AND SAFETY REQUIREMENTS The tests necessary to check compliance with EHSRs are often destructive, and may require several samples of the PPE concerned. So this aspect of market surveillance involves either the taking or the purchase of the required number of samples (depending on the surveillance authorities’ powers). Tests may be carried out within the authorities own facilities when these are available, or else entrusted to competent laboratories. In general, when the type of PPE concerned is covered by harmonized standards, the appropriate tests are those described in the relevant standard. If no harmonized standard exists, or if the manufacturer has applied other criteria for conformity evaluation, it may be necessary to determine appropriate tests. In many cases, it may be considered unnecessary to carry out all the tests laid down by the harmonized standard. Time and money may be saved by limiting the checks to test with particular importance for the safety of users, or sufficient to determine the level of protection afforded by the PPE. In many cases the laboratories most competent and best equipped to carry out the tests are the laboratories of Notified Bodies, but it must be clear that in this case the body is not acting as a NB but as a test-house on behalf of the market surveillance authorities. When the market surveillance authorities receive the test reports, manufacturers should whenever possible be informed of the results and asked to present their observations, before action is decided. Exceptions may be justified, if action is considered urgent to protect the safety of users. Experience shows that in most cases, when market surveillance checks reveal anomalies, corrective measures are agreed by the manufacturer. These corrective measures may include completion of the conformity evaluation procedure, modifications concerning the product and the instructions for use, or improvement of the arrangements for quality control of the production. When surveillance reveals substantial problems concerning either the PPE itself or the information supplied to users, manufacturers may be asked to withdraw products from the market and/or inform their customers. In the case of noncompliant PPE, after taking into account the observations presented by manufacturers, and in light of the seriousness of the non-compliance, the market surveillance authorities have to determine the appropriate course of action. Several possibilities are open. IF ADEQUATE CORRECTIVE MEASURES ARE AGREED BY THE MANUFACTURER When the manufacturer and the authorities agree on corrective measures, and these are considered sufficient to protect the health and safety of users provided sufficient assurance is given that these measures will effectively be carried out, the market surveillance authorities may consider the file to be closed. In the majority of cases this outcome is doubtful. This situation raises a problem, since technical harmonization introduced by the directive has created a single market enabling PPE to move freely across national borders, but the market surveillance authority is competent only for the national market. If a problem has reached a satisfactory solution in one Member State, an unscrupulous manufacturer may be tempted to sell off noncompliant stock in other Member States where the problem may not be detected.
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