A manufacturer must run, and keep reviewing, an approval process for each product and each significant adaptation before marketing or distribution. For every product that is not closed, the procedures must pin down the target market with enough granularity, including what the customers in it need, what characterises them and what they are aiming for and of any group with characteristics of vulnerability, must ensure the product is designed to meet those needs and to avoid causing foreseeable harm, must assess the risks to the target market, and must set a distribution strategy appropriate to it. Where firms co-manufacture they must record their respective roles in a written agreement. The rules apply to new products made on or after 31 July 2023 and to existing products; firms already subject to PROD 3, 4 or 7 follow those chapters for the products in scope.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.