Swissmedic Publishes Guidance on the Procurement of Medical Devices in Healthcare Institutions
Swissmedic has published Version 6.0 of the Information Sheet – Procurement of Medical Devices in Healthcare Institutions, providing guidance to support healthcare institutions when procuring medical devices and in vitro diagnostic medical devices (IVDs).
The document outlines the key requirements for verifying the regulatory compliance of medical devices, the documentation that should be requested from suppliers, and the use of databases such as swissdamed, EUDAMED and NANDO during procurement activities.
Verification of Conformity Documentation
The guidance describes the different conformity certificates that may be required depending on the classification of the device and the applicable regulatory framework.
The document provides examples of the certificates commonly used for different classes of medical devices and IVDs, together with the corresponding conformity assessment procedures.
Swissmedic also explains that certificates should be issued by appropriately designated conformity assessment bodies for the applicable legislation.
Verification of Certificates and Notified Bodies
The guidance explains how healthcare institutions can verify the validity of certificates provided by suppliers.
Among the resources highlighted are:
The NANDO database for verifying Notified Bodies;
The EUDAMED database for verifying certificates issued under the MDR and IVDR;
Verification tools made available by individual Notified Bodies to confirm certificate authenticity.
The document also clarifies that certificates relating to standards such as ISO 13485 or ISO 9001 do not replace conformity certificates issued under the applicable medical device legislation.
Use of swissdamed and EUDAMED
The guidance provides information on the use of swissdamed and EUDAMED as sources of regulatory information during procurement activities.
According to Swissmedic:
swissdamed is the Swiss database for the registration of economic operators and medical devices;
EUDAMED provides information on devices, manufacturers and certificates issued under the MDR and IVDR.
The document also explains how these databases can be used to verify relevant regulatory information.
Devices Covered by Transitional Provisions
Swissmedic notes that Switzerland has adopted transitional provisions aligned with those implemented in the European Union for devices certified under the former MDD, AIMDD and IVDD legislation.
The guidance explains that certain certificates issued under the previous legislation may continue to remain valid in Switzerland, provided the applicable regulatory conditions are fulfilled.
Relevance for Medical Device and IVD Manufacturers
Although the guidance is primarily intended for healthcare institutions procuring medical devices, several sections are also relevant for manufacturers and other economic operators.
Topics of particular interest include:
Conformity certificates;
Regulatory documentation provided to customers;
Verification of device compliance;
Use of swissdamed and EUDAMED;
Requirements applicable during the MDR and IVDR transitional periods.
For manufacturers, the guidance highlights the importance of providing complete and up-to-date regulatory documentation to demonstrate device compliance during procurement processes.
