This EU MDR Special Responsibilities Procedure complies with EU MDR 2017/745 and ISO 13485:2016. Delivered in editable Word format, it defines responsibilities for PRRC, distributors, importers, and manufacturers under EU MDR. Digital delivery within 24 business hours.
This procedure outlines obligations for the Person Responsible for Regulatory Compliance (PRRC), vigilance reporting, PMS, PMCF, UDI assignment, EUDAMED registration, distributor/importer controls, and regulatory communication. Delivered in editable Word format for easy customization. Consultancy support is available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are available for an additional fee.