Swissmedic Publishes “Good Practice for Materiovigilance in Hospitals” (GPMV-Spital)
Swissmedic, in collaboration with several Swiss healthcare and quality organizations, has published the document “Swiss Good Practice for Materiovigilance in Hospitals (GPMV-Spital)”, version 1.00, effective from April 2026.
The document provides a structured framework for the implementation of materiovigilance requirements in hospitals, based on existing Swiss legislation.
A practical implementation of legal requirements
The GPMV-Spital is not a new regulation, but rather a practical interpretation and operationalization of existing legal obligations, particularly those defined in the Swiss Therapeutic Products Act (HMG) and the Medical Devices Ordinance (MepV).
It combines:
mandatory requirements derived from legislation
recommendations based on current practice and standards
Its primary objective is to support hospitals in ensuring effective materiovigilance and strengthening patient safety.
Focus on post-market surveillance
The document reinforces that, despite pre-market conformity assessment, risks may only become apparent during real-world use.
Materiovigilance is therefore essential and includes:
collection and analysis of incidents and serious incidents
implementation of corrective measures
prevention of recurrence of safety issues
Key elements for hospitals
The GPMV-Spital defines how hospitals should organize materiovigilance in practice, including:
Establishment of an internal reporting system
Designation of a materiovigilance contact person
Implementation of structured processes within a Quality Management System (QMS)
Staff training and clear definition of roles and responsibilities
Ensuring traceability of medical devices
It also reinforces the existing dual reporting obligation, requiring healthcare professionals to report serious incidents to both Swissmedic and the supplier.
Implications for medical device manufacturers
Although the guideline is not addressed to manufacturers, it has important indirect implications:
More structured feedback from hospitals: clearer internal processes may improve the quality and consistency of incident reporting
Reinforced dual reporting system: manufacturers may receive more systematic reports from users
Stronger FSCA execution: hospitals are expected to implement Field Safety Corrective Actions (FSCAs) in a traceable and controlled manner
Greater emphasis on traceability: including the use of UDI and documentation practices
These elements contribute to a more robust and transparent post-market surveillance environment.
Regulatory context
The GPMV-Spital is based on Swiss legislation (HMG, MepV), which includes references to the EU Medical Device Regulation (EU MDR 2017/745), reflecting the existing regulatory alignment between Switzerland and the European framework.
Final takeaway
This publication represents an important step in standardizing materiovigilance practices at hospital level.
For manufacturers, it signals a more structured and consistent post-market environment, requiring continued attention to vigilance systems, communication with users, and effective management of safety-related information.
Read the full document below.
