Subsection 4: Conformity assessment procedures applicable to personal protective equipment

In order to assess the quality assurance system, the notified body shall carry out all necessary objective assessments of the elements of this system. In particular, it shall ensure that the system guarantees the conformity of each item of personal protective equipment with the model which has been the subject of an EC type-examination certificate. The body notifies the manufacturer of its decision.

The manufacturer must inform the body which approved his quality assurance system of any proposed changes to that system. The body must examine the proposed modifications and decide whether the quality assurance system continues to meet the provisions of Articles R. 4313-64 to R. 4313-67. The body must notify the manufacturer of its decision concerning the modified quality assurance system.

The notified body checks, by means of surveillance, that the manufacturer duly fulfils the obligations arising out of the approved quality assurance system.

The manufacturer shall allow the notified body access to the premises where the personal protective equipment is inspected, tested and stored and shall provide all necessary information, in particular: 1° The documentation on the quality assurance system, including the quality manuals ; 2° technical documentation.

The notified body must periodically carry out investigations and checks to ensure that the manufacturer maintains and applies the approved quality assurance system. The body may pay unannounced visits to the manufacturer. It provides the manufacturer with a visit report and, where appropriate, an expert report. The notified body’s reports are sent to the manufacturer under the conditions set out in Articles R. 4313-58 and R. 4313-59.

Where the notified body concludes that the approved quality assurance system has been applied incorrectly, it may, depending on the seriousness of the defects found: – either request the necessary modifications to the system. – decide to withdraw approval.

In the event of withdrawal of approval of the quality assurance system, manufacture may not continue until the manufacturer has implemented an EC quality assurance system which complies with the provisions of paragraph 1 of this subsection. The safeguard procedure provided for in Chapter IV may also be implemented.

The possibilities of complaint provided for in Article R. 4313-35 are applicable to the decisions of the notified body provided for in this paragraph.