Glossary · EU in vitro diagnostics: IVDR
In-house devices (MDR and IVDR Article 5(5))
Also known as: Health institution exemption, In-house exemption, Laboratory-developed tests (EU)
Under Article 5(5) of the EU Medical Device Regulation (EU) 2017/745 and of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, devices manufactured and used only within health institutions established in the EU are exempt from most requirements of the regulations, provided set conditions are met. The general safety and performance requirements still apply.
- EU
- MDR
- IVDR
In one sentence
In-house devices under MDR and IVDR Article 5(5): devices made and used within an EU health institution are largely exempt, if strict conditions are met.
Example
A university hospital laboratory develops a genetic test for a rare disease for which no CE-marked test exists. It documents the justification, works under ISO 15189, publishes the required declaration and uses the test only for its own patients.
How it applies
- No transfer: The devices are not transferred to another legal entity and are not manufactured on an industrial scale.
- Quality system: The health institution works under an appropriate quality management system. For IVDR laboratories this means compliance with ISO 15189 or, where applicable, national provisions including accreditation.
- Justification: The institution justifies that the target patient group’s specific needs cannot be met, or not at the appropriate level of performance, by an equivalent device on the market.
- Transparency and review: It makes a public declaration about the devices, keeps documentation on the manufacturing facility, design and performance, provides information to the competent authority on request, reviews clinical experience and takes corrective actions.
- Guidance and national rules: MDCG 2023-1 explains the health institution exemption. Member states may restrict the manufacture and use of in-house devices, so check the national provisions.
- Technical documentation: The documentation must show how the GSPR are met, even though no conformity assessment or CE marking is required. The justification against market alternatives needs updating when new CE-marked devices appear.
In-house device vs. custom-made device
An in-house device is made and used by a health institution for its own patients under Article 5(5). A custom-made device under the MDR is made by a manufacturer on the written prescription of an authorized person for the sole use of a particular patient, and follows its own procedure and statement. The IVDR has no custom-made category, which is why the in-house exemption matters so much for laboratories.