Devices with requirements of their own
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This branch covers device categories with specific evidence and documentation needs, divided by type: software and connected devices, in vitro diagnostics, companion diagnostics, combination products and animal-tissue devices. It leaves the overall market-access framework and general borderline classification to neighbouring topics.
- Software and connected devices — regulatory development, qualification and risk class, software documentation, cybersecurity and connectivity
- In vitro diagnostics under the IVDR — uses of diagnostics, the regulatory transition, IVDR and MDR differences, corresponding documents and clinical performance study terms
- Companion diagnostics — definition, risk class, assessing authorities, document requirements and co-development with a medicine
- Drug-device and device-drug combination products — forms and classification, US and EU routes, evidence for each component, Article 117 opinions, coordinated development and safety reporting
- Devices made from animal tissue — tissue uses, ISO 22442 risk and sourcing controls, viral and prion safety, and zoonosis surveillance