Section 2: Conformity assessment procedures

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.