Article 2 — Definitions

Source: EU MDR 2017/745 Article 2 | OJ L 117, 5.5.2017

Core Definitions (EN/ZH)

Device Categories

Term (English)	Term (Chinese)	Definition Summary
medical device	医疗器械	Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; providing information by means of in vitro examination of specimens derived from the human body; and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body.
in vitro diagnostic medical device (IVD)	体外诊断医疗器械	Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.
Annex XVI product	附件XVI产品	Products without an intended medical purpose that are similar to medical devices (e.g., contact lenses, aesthetic implants), listed in Annex XVI.
custom-made device	定制器械	Any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
active device	有源器械	Any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy.
implantable device	植入式器械	Any device, including those that are partially or wholly absorbed, which is intended: to be totally introduced into the human body, or to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure.
reusable surgical instrument	可重复使用外科器械	An instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.
single-use device	一次性器械	A device that is intended to be used during a single procedure.

Economic Operators

Term (English)	Term (Chinese)	Definition Summary
manufacturer	制造商	A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
authorised representative	授权代表	Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.
importer	进口商	Any natural or legal person established within the Union that places a device from a third country on the Union market.
distributor	经销商	Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.
economic operator	经济运营商	A manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3).

Compliance and Market Access

Term (English)	Term (Chinese)	Definition Summary
intended purpose	预期目的	The use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.
label	标签	The written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices.
instructions for use	说明书（IFU）	The information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken.
placing on the market	投放市场	The first making available of a device, other than an investigational device, on the Union market.
putting into service	投入使用	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.
CE marking	CE标志	A marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.
conformity assessment	合规评估	The process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled.

Clinical and Safety

Term (English)	Term (Chinese)	Definition Summary
clinical evaluation	临床评价	A systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
clinical investigation	临床调查	Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.
clinical data	临床数据	Information concerning safety or performance that is generated from the use of a device and is sourced from clinical investigations, scientific literature, or clinically relevant information coming from post-market surveillance.
performance	性能	The ability of a device to achieve its intended purpose as stated by the manufacturer.
serious incident	严重事故	Any incident that directly or indirectly led, might have led or might lead to any of the following: the death of a patient, user or other person; the temporary or permanent serious deterioration of a patient's, user's or other person's state of health; a serious public health threat.
field safety corrective action (FSCA)	现场安全纠正措施	Corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
post-market surveillance (PMS)	上市后监督	All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.

Notified Bodies and Regulatory

Term (English)	Term (Chinese)	Definition Summary
notified body	公告机构	A conformity assessment body designated in accordance with this Regulation.
competent authority	主管机构	The authority or authorities responsible for the implementation of this Regulation within a Member State.
EUDAMED	EUDAMED	The European database on medical devices.
unique device identifier (UDI)	唯一器械标识	A series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.

Key Concepts Interpretation

Core Elements of "Medical Device" Definition

Intended Purpose: Declared by the manufacturer in the label/instructions for use/promotional material.
Mechanism of Action: The principal intended action is not achieved by pharmacological, immunological or metabolic means (otherwise it is a medicinal product).
Target: Intended to be used for human beings for medical purposes such as diagnosis, prevention, monitoring, or treatment.

Software as a Medical Device (SaMD)

Software can constitute a medical device, provided that:

It has a medical purpose (diagnosis, monitoring, treatment, etc.).
The principal action is not achieved by pharmacological/immunological/metabolic means.

See MDCG 2019-11: Guidance on Qualification and Classification of Software

Extension of "Manufacturer" Definition

The following scenarios are also considered as acting as a manufacturer:

Persons who assemble, package, process, fully refurbish or label one or more ready-made products, or assign to them their own intended purpose as a device.
Persons who modify the intended purpose of a device already placed on the market or put into service.
Persons who place a device on the market under their own name.

Official Sources