The Medical Devices Introductory Course 2020

Vigilance

Regulatory requirements – Medical Device Regulations New regulations significantly reinforces health and safety of patients and users:-

MDR 2017/745, Article 10..

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section 9 “Processes for reporting of serious incidents and FSCA’ s in the context of vigilance”

section 13 “Manufacturers shall have a system of recording and reporting incidents and FSCA’ s as described in Articles 87 & 88”

The Organisation for Professionals in Regulatory Affairs

Vigilance

MDR 2017/745, Article 87..

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“Reporting of serious incidents and field safety corrective actions”

• Sets out requirements for reporting serious incidents to the authorities and conducting Field Safety Corrective Actions • Establishes 3 categories of reportable incident • 2 days • 10 days • 15 days • Describes a predisposition to report • Establishes requirement to notify NCA prior to implementing any FSCA, unless…

• Include Periodic Summary Reporting (PSR) • Sets out requirements for ‘user reports’

The Organisation for Professionals in Regulatory Affairs