Swissmedic Provides Definition for In-House IVDs

Swissmedic has recently updated their FAQ that provides the definition for in-house IVDs, and examples of what is and isn’t an In-house IVD. 

Read Swissmedics full update here. 

Key points to note:

• • • In-house IVDs are considered to be put into service, but they are not considered to be placed on the market. They must also not be manufactured on an industrial scale. 
    • In-house IVDs must be notified to Swissmedic. 

They specify further obligations for:

• • • Vigilance 
    • Maintenance 
    • Cybersecurity 
    • Licensing for Microbiological laboratories 

Which manufacturers does this apply to?

This applies to in-house IVD manufacturers. 

Is there any impact on manufacturers?

There was no impact on manufacturers, just additional guidance provided by Swissmedic  

If you have any inquiries or need additional clarification regarding Swissmedic’s updates on the definition for in-house IVDs, feel free to reach out to us. Our team is available to discuss ways to ensure your compliance.