The In Vitro Diagnostic Regulation governs the devices that examine samples from the human body, from blood-test analysers and pregnancy tests to companion diagnostics and software.

It applies to manufacturers, authorised representatives, importers and distributors, and it sorts every device into four risk classes, A to D. Classes B, C and D need a notified body; only Class A can generally be self-certified.

Adopted in May 2017, it has applied since 26 May 2022, replacing the IVD Directive; the transition dates for legacy devices were extended by Regulation 2022/112 and later amendments.

You classify the device, engage a notified body early for classes B to D, build technical documentation with a performance evaluation, appoint an EU representative if you are outside the EU, assign UDIs and register in EUDAMED, and run post-market surveillance and vigilance.

Conphora maps your devices against IVDR, flags gaps in classification, performance evidence, notified-body assessment, UDI and EUDAMED registration, and alerts you when obligations or deadlines change.

The full guide is at conphora.com.