The Medical Devices Introductory Course 2020

Vigilance

QUIZ..

Is Prefilled syringe reportable under Med Dev Vigilance?

No

PMOA determine lead Directive ?

Medicinal Product Directive 2001/83/EEC

The Organisation for Professionals in Regulatory Affairs

Vigilance

MANUFACTURER RESPONSIBILITY

● Staying up to date with regulatory requirements and regulator expectations ● Establishing a process that meets these requirements ● Embedding this process into the Quality Management System –

This means:-

– The manufacturers QMS – Training / implementation – Any delegation is controlled & documented with evidence of effectiveness – Ensuring that requirements are adhered to – ISO13485, 8.2.2 (complaint handling) – Monitoring the effectiveness of this process – ISO13485, 8.1

The Organisation for Professionals in Regulatory Affairs