Checklist for the Inspection of Medical Device Vigilance in Hospitals

Key changes

Introduction of a formal checklist tool for hospital materiovigilance inspections, focusing on the reporting of incidents and the role of the vigilance contact person.

PV impact

Updates the inspection framework for medical device vigilance in Switzerland; hospitals and potentially associated MAH stakeholders should use the checklist to ensure incident reporting compliance.

Exact policy details

Applicable Legislation

The health facility identifies and applies relevant laws and regulations for its operations.

Applies to: All healthcare facilities conducting medical device vigilance

1.3.1 · p. 1 · High · Source

Quality Management Responsibility

The management is responsible for implementing regulatory requirements regarding vigilance processes.

Applies to: Healthcare facility management

3.1, 3.3 · p. 1 · High · Source

Retention Period for Records

Documents related to materiovigilance must be retained for at least 15 years.

Applies to: All medical device documentation

3.7, 6.1, 6.10, 8.5 · p. 1 · High · Source

Notification of Serious Incidents

Serious incidents must be reported within 2, 10, or 15 days depending on the severity.

Applies to: Healthcare facilities reporting serious incidents

6.1, 6.6 · p. 1 · High · Source

Vigilance Contact Person

A vigilance contact person must be appointed and reported to Swissmedic.

Applies to: Every healthcare facility

3.3.2 · p. 1 · High · Source

Extracted documents

• Checklist for the inspection of medical device vigilance in hospitalshtmlhtml · medium · 1 page
• IN615_10_004d_CL Checkliste für die Inspektion von Systemen der Vigilance betreffend Medizinprodukten (DOCX, 1 MB, 22.06.2026)docxdocx · high · 1 page
• PDF invoice by e-mailhtmlhtml · medium · 1 page
• Medical deviceshtmlhtml · medium · 1 page