What is Article 11?
Article 11 of the Directive covers the ongoing relationship between manufacturer and Notified Body for items of PPE categorised as Complex Design. One of two mandatory routes can be chosen, either Article 11A or Article 11B. Article 11A involves a system of annual retests on samples independently selected by the Notified Body. Article 11B is usually more applicable to companies operating an ISO 9000 level quality management system and involves a site visit assessment of the manufacturer’s ability to make consistent products. This audit must be carried out by a European PPE Notified Body.
