In-house devices are medical devices or in vitro diagnostic medical devices that can be used in health institution without having to comply with most of regulatory provisions of EU MDR or EU IVDR e.g., an in-house device does not require a CE-mark, thus cannot be placed on the European market as CE-marked devices, but may only be used in health facility to meet the specific needs of targeted patient groups that cannot be met, or cannot be met at the appropriate level of performance, by an equivalent CE-marked device available on the market, in accordance with Article 5(5) of EU MDR or IVDR. However, prior to the first manufacture of an in-house device, a health institution should check the market for the existence and availability of equivalent CE-marked devices, taking consideration of the following aspects.
- specific needs of targeted patient groups: specific needs here means that a patient group requires a specific device e.g., a CE-marked device is only for the adult population but not for pediatric patients, or that a specific level of performance of a device is required e.g., a more sensitive method.
- a CE-marked device is not available to meet patient groups’ specific needs at the appropriate level of performance based on the assessment of the technical, biological or clinical equivalence of the device.
- health institution should review publicly available information regarding the equivalent devices in the European database- EUDAMED or other sources to justify the need for in-house devices.
If a health facility concludes that no equivalent product is available on the European market, it may develop and manufacture its own products. The in-house devices must comply with general safety and performance requirements (GSPR) set out in Annex I of EU MDR or IVDR, even though most of EU MDR or IVDR requirements do not apply to in-house devices. It should also be clear that such a device can only be manufactured and used within the same health institution, i.e., it cannot be transferred to another legal entity. In addition, in-house devices should be produced in quantities that meets the patient groups’ specific needs, but no more than necessary, meaning that production should not be on an industrial scale. Last, but not least, health institution must issue a declaration and make it publicly available. This procedure is somewhat similar to EU declaration of conformity for CE-marking.
in order to keep in-house device manufacturing up-to-date with market developments, health institution shall regularly collect information about the availability on the market and performance of potentially equivalent CE-marked device. Once the in-house device is in use, a possible subsequent availability on the market of an equivalent device does not invalidate the initial justification for compliance with the requirements referred to in Article 5(5) of EU MDR or IVDR at the time of the start of the in-house manufacture. However, in such a case, the health institution should review and update its justification. If a CE-marked device proves to be at least equivalent to the in-house device and meets the specific needs of the target patient group at the appropriate level of performance, a transition process towards the usage of the CE marked device should start.