Article 15 requires manufacturers to have permanently available within their organisation at least one Person Responsible for Regulatory Compliance (PRRC) with the requisite expertise in the field of in vitro diagnostic medical devices. The PRRC has the formal responsibility to ensure: (a) the conformity of devices before release; (b) technical documentation and the EU DoC are drawn up and kept up to date; (c) post-market surveillance obligations (Article 10(9)); (d) vigilance reporting (Articles 82-86); (e) for investigational devices, the Article 70 declaration. Article 15(2) permits micro-enterprises / small enterprises to engage an external PRRC.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.