Borderline product

A product whose regulatory status is unclear — whether it is a device, a medicinal product, a cosmetic, a biocide or something else. Member States may ask the Commission to determine the status of a specific product or group of products by implementing act, after consulting the MDCG.

Reference: MDR Article 4; IVDR Article 3

Certificate of free sale

A certificate issued by a Member State, at the manufacturer’s request, confirming that a device may lawfully be sold in the Union. Typically requested to support registration in export markets.

Reference: MDR Article 60

Distance sales

Devices offered through information society services to a person in the Union must comply with the regulation. This extends to devices not placed on the market but used to provide a diagnostic or therapeutic service remotely, and a copy of the declaration of conformity must be made available on request.

Reference: MDR Article 6; IVDR Article 6

HIE — Health institution exemption

The route allowing a health institution to manufacture and use devices internally without full conformity assessment, subject to conditions: the devices are not transferred to another legal entity, they are made under an appropriate quality management system, a public declaration is drawn up, and no equivalent device on the market meets the patient group’s needs at the required performance level.

Reference: MDR Article 5(5); IVDR Article 5(5)

LDT — Laboratory developed test

An IVD developed and used within a single laboratory rather than placed on the market. In the EU these fall under the health institution exemption in IVDR Article 5(5) rather than being a separate regulatory category, so the exemption conditions determine what is permitted.

Reference: IVDR Article 5(5)

Making available on the market

Any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. Under the IVDR: any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

Reference: MDR Article 2(27); IVDR Article 2(20)

Placing on the market

The first making available of a device, other than an investigational device, on the Union market. Under the IVDR: the first making available of a device, other than a device for performance study, on the Union market.

Reference: MDR Article 2(28); IVDR Article 2(21)

Putting into service

The stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose. Under the IVDR: the stage at which a device, other than a device for performance study, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.

Reference: MDR Article 2(29); IVDR Article 2(22)

RUO — Research use only

A product not intended for in vitro diagnostic examination and therefore outside the IVDR, unless the manufacturer specifically intends it for diagnostic use in view of its characteristics. Labelling a product research use only does not exempt it if its intended purpose is diagnostic.

Reference: IVDR Article 1(3)(a)