Swissdamed Handbook: User's Guide

Exploring the Actor Registration Module for Economic Operators – Concept, Registration, Management, Access, and Mandates.

On the 20th of June, 2023, Swissmedic is set to launch the pilot phase of the initial release of the new Swiss Database on Medical Devices (swissdamed) with a select group of companies. This User Guide for Economic Operators aims to furnish companies with a comprehensive overview and instructions pertaining to the current operational features of the system.

Section 1: Overview of swissdamed

The Swiss Database on Medical Devices (swissdamed) is an advanced IT system designed by the Swiss Agency for Therapeutic Products (Swissmedic) to effectively implement the regulations governing medical devices in Switzerland. These regulations include:

- Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA) - Article 812.21

- Medical Devices Ordinance (MedDO) - Article 812.213

- Ordinance on In Vitro Diagnostic Medical Devices (IvDO) - Article 812.219

These regulatory texts are aligned with the corresponding medical devices regulations of the European Union:

- Regulation 2017/745 on medical devices

- Regulation 2017/746 on in vitro diagnostic medical devices

swissdamed Structure:

swissdamed is built upon two interconnected modules and a public site, each serving a distinct purpose:

1. Company and Actor-User Registration and Management: This module facilitates the registration and oversight of companies and their associated actors. Actors may include individuals involved in the medical devices sector. The module streamlines the registration process and provides tools for efficient management.

2. UDI Database and Device Registration: This module, scheduled for availability in Release 2, focuses on the Unique Device Identification (UDI) database and the registration of medical devices. This component is designed to enhance tracking and monitoring.

It's worth noting that swissdamed's architecture is rooted in a robust framework designed to align with both Swiss and EU medical device regulations, fostering transparency, efficiency, and regulatory compliance.