IVDR

Is EEG data considered a "specimen" under the IVDR?

Is it possible to consider data as a "specimen" under the IVDR? Specifically, our company analyzes EEG data samples in a similar fashion to how DNA analysis companies handle...

Do IVDR Annex IX Chapter II certificates apply to Class C devices?

Our company received an EU Quality Management System Certificate (IVDR) for Annex IX Chapters I and III. We have a Class C device (not for self-testing, near patient testing, or...

Is it permissible to provide access to a DiGA app before insurance approval?

We are developing a DiGA app and would like to allow users to start using the app before their insurance company has approved their access (i.e., before they receive the code...

Is a saliva microbiome genetic test a medical device under IVDR?

We are considering developing a test that analyzes microbes present in human saliva using gene sequencing. The test would tell users in general terms if these microbes are...

Is a 95,000€ IVDR certification quote typical for a small software manufacturer?

Our company is pursuing IVDR certification for four software programs/algorithms that estimate disease risk based on genetic data. We did not require certification under IVDD...

How should IVDR Annex I, Article 9.1(a) requirements be addressed for SaMD-IVDs in the GSPR?

I am preparing the General Safety and Performance Requirements (GSPR) for a software as a medical device (SaMD) intended for in vitro diagnostic (IVD) use and have a question...