To monitor the traceability of medical devices throughout the supply chain, the European Regulations place not only more stringent requirements for Manufacturers, but also expect greater involvement from other economic operators and Notified Bodies.
Pursuant to MDR, the manufacturer must have in place:
- a quality management system (QMS);
- a post-market surveillance system (PMS);
- a risk management system;
- a system for reporting incidents and safety corrective actions (vigilance) to the competent Authorities.
The Manufacturer must “plan, establish, document, apply, maintain and update a post-marketing surveillance system, an integral part of the organization’s quality management system” (Ref. Art. 83 of MDR and Art.78 of IVDR)
The activities related to PMS must be guaranteed within the manufacturer’s organization by a Person Responsible for regulatory compliance, in possession of the minimum qualification requirements (Ref. Art. 15 of MDR).
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