Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) "medical device" means any instrument, apparatus, appliance, software, implant, reagent, material, or other object intended by the manufacturer to be used, alone or in combination, in humans for one or more of the following specific medical beings purpose:
| — | diagnosis, prevention, monitoring, prediction, prognosis, treatment oral disease relief, |
| — | diagnosis, monitoring, treatment, relief or compensation for injury or disability; |
| — | examination, replacement or alteration of anatomy or a normal or pathological process or condition, |
| — | providing information through in vitro examination of samples derived from the human body, including organs, blood and tissues donations, |
and which does not achieve its primary intended effect by pharmacological, immunological or metabolic means in or on the human body, but may be assisted in its function by such means.
The following products are also considered medical devices:
| — | devices to control or assist conception; |
| — | products specifically intended for cleaning, disinfection or sterilization of equipment referred to in Article 1, paragraph 4, and those referred to in the first paragraph of this point. |
2) "accessory to a medical device": an item which, although not a medical device itself, is intended by the manufacturer to be used with one or more specific medical devices to specifically enable the medical device to be used in accordance with the intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in relation to the intended purpose(s)
(3) "custom-made device" means any device specially manufactured in accordance with the written prescription of any person authorized under national law by virtue of that person's professional qualifications and which, under his responsibility, provides specific design features and is intended for exclusive use use by a specific patient solely to meet his or her particular conditions and needs.
However, mass-produced devices that must be customized to meet the specific requirements of any professional user and devices that are mass-produced through industrial manufacturing processes according to the written instructions of any authorized person are not considered custom-made devices.
(4) "active device" means any device the operation of which depends on a source of energy other than that produced by the human body for that purpose or by gravity, and which works by changing the density or converting this energy. Devices intended to transfer energy, substances or other elements between an active device and the patient, without any significant change, are not considered active devices.
The software will also be considered an active entity.
(5) "implantable assistive device" means any device, including partially or fully absorbable device, which is intended to:
| — | be fully introduced into the human body, or |
| — | for replacement of an epithelial surface or the surface of the eye, |
with clinical intervention and which are intended to remain in place after the procedure.
Any device intended to be partially inserted into the human body by clinical procedure and intended to remain in place after the procedure for at least 30 days is also considered an implantable device.
(6) "invasive device" means any device which penetrates wholly or partially into the interior of the body, either through an opening in the body or through the surface of the body;
(7) "general unit group": a set of equipment having the same or similar intended purpose or a common technology that allows them to be classified in a general way that does not reflect specific characteristics;
8) "disposable device": a device intended to be used on a single person during a single procedure;
9) "counterfeit device": any device with a false presentation of its identity and/or the source and/or CE marking certificates or documents related to CE marking procedures. This definition does not include involuntary non-compliance and does not affect infringements of intellectual property rights.
10) "procedural pack" means a combination of products packaged together and placed on the market with the intention of being used for a specific medical purpose;
(11) "system": a combination of products, whether packaged together or not, which are intended to be connected or combined to achieve a specific medical purpose;
(12) "intended purpose": the use for which a device is intended according to the data provided by the manufacturer on the label, in the instructions for use or in advertising or sales materials or statements and as defined by the manufacturer in the clinical evaluation?
(13) "label" means the written, printed or graphic information found either on the equipment itself or on the packaging of each unit or on the packaging of multiple units;
14) "instructions for use": information provided by the manufacturer to inform the user of the intended purpose and correct use of a device and of any precautions to be taken;
(15) "Unique Device Identifier" ("UDI"): a series of numeric or alphanumeric characters generated through internationally accepted device identification and coding standards that enable specific devices to be uniquely identified in the marketplace.
(16) "non-viable" means incapable of metabolism or reproduction;
(17) "derivative": "non-cellular substance" extracted from human or animal tissues or cells through a manufacturing process. In this case, the final substance used to make the device does not contain cells or tissue.
18) "nanomaterial": natural, random or engineered material containing particles in an unbound or inert or aggregated state and where one or more external dimensions for 50% or more of the particles in the number size distribution are in the size range 1-100 nm.
Fullerenes, graphene flakes and single-walled carbon nanotubes with one or more outer dimensions below 1 nm are also considered nanomaterials.
19) "particle", in relation to the definition of nanomaterial in clause (18), means a fine piece of matter with defined physical boundaries;
20) "aggregates", for the purposes of the definition of nanomaterial in point 18: an assembly of weakly bonded particles or aggregates where the resulting external surface area is equal to the sum of the surface areas of the individual components.
21) "aggregated material" in the context of the definition of nanomaterial in point (18): a particle consisting of strongly bonded or fused particles.
22) "performance" means the ability of a device to achieve its intended purpose, as indicated by the manufacturer;
23) "risk": the combination of the probability of damage occurring and the seriousness of this damage;
24) "benefit-risk assessment": the analysis of all benefits and risk assessments of potential relevance to the use of the product for its intended purpose when used in accordance with the intended purpose indicated by the manufacturer.
(25) "compatibility" means the ability of a device, including software, when used with one or more other devices in accordance with its intended purpose:
| (in) | perform without losing or compromising the ability to perform as intentional and/or |
| (and) | incorporate and/or operate without the need for modification or adaptation of any part of the combined units and/or |
| (do) | used together without conflict/interference or adverse effect. |
(26) "interoperability" means the ability of two or more devices, including software, from the same manufacturer or from different manufacturers to:
| (in) | they share information and use the information they have exchanged to properly perform a specified function without changing the content of data and/or |
| (and) | communicate with each other and/or |
| (do) | cooperation as intended. |
(27) "making available on the market" means any supply of equipment, other than research equipment, for distribution, consumption or use on the Union market in connection with a commercial activity, whether for payment or free of charge;
28) "marketing" means the first placing on the EU market of a medical device other than the investigational device
(29) "putting into service" means the stage at which a device, other than an experimental device, has been made available to the end-user as ready for use on the Union market for the first time for its intended purpose;
30) "manufacturer": a natural or legal person who manufactures or completely refurbishes a device or has designed, manufactured or completely refurbished a device and markets the device under its name or trademark
(31) "complete refurbishment" means, as defined by the manufacturer, the complete rebuilding of an appliance already placed on the market or put into service, or the construction of a new appliance from used appliances to comply with this Regulation in connection with the assignment of a new life to the refurbished unit;
(32) "authorised representative" means any natural or legal person established in the Union who has received and accepts a written authorization from a manufacturer established outside the Union to act on behalf of the manufacturer in relation to specific tasks related to its obligations under this Regulation;
33) "importer" means any natural or legal person established in the Union who brings equipment from a third country onto the Union market;
34) "distributor" means any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a product available on the market until it is put into use;
35) "economic operator": manufacturer, authorized representative, importer, distributor or the person referred to in Article 22, paragraph 1 and 3;
(36) "health institution" means an organization whose primary purpose is the care or treatment of patients or the promotion of public health;
(37) "user" means any health professional or lay person who uses a device;
(38) "lay person" means a person who has no formal training in a relevant health field or medical discipline;
39) "reprocessing": a process carried out on a used medical device to enable its safe reuse, including cleaning, disinfection, sterilization and related procedures, as well as testing and restoration of the technical and functional safety device used;
(40) "conformity assessment" means the process of determining whether the requirements of this Regulation are met in relation to a piece of equipment.
(41) "conformity assessment body" means an organization that carries out third-party conformity assessment activities, including calibration, testing, certification and inspection;
(42) "notified body" means a conformity assessment body designated in accordance with this Regulation.
44) "clinical evaluation" means a systematic and planned process for the continuous generation, collection, analysis and evaluation of clinical data related to a medical device to verify the safety and performance, including the clinical benefits, of the product when used as intended by the manufacturer?
(45) "clinical study" means any systematic study involving one or more human subjects and conducted to evaluate the safety or performance of a device.
(46) "investigational device" means a device evaluated in the context of a clinical trial.
47) "clinical research plan": a document describing the rationale, objectives, design, methodology, monitoring, statistical estimates, organization and conduct of a clinical research;
(48) "clinical data" means safety or performance information generated by the use of a device and derived from the following:
| — | clinical studies of the relevant equipment; |
| — | clinical research or other studies that refer to scientific literature on a unit for which equivalence with said unit can be demonstrated, |
| — | reports published in peer-reviewed scientific literature for others clinical experience with either the device in question or an additional device which equivalence with said device can be demonstrated, |
| — | clinically relevant information from post-marketing surveillance, especially post-marketing clinical surveillance; |
(49) "sponsor": any person, company, institution or organization that assumes responsibility for initiating, managing and generating funding for clinical research;
50) "person": a person participating in a clinical trial;
52 by the manufacturer?
(52) "clinical performance" means the ability of a medical device, as a result of direct or indirect medical effects resulting from its technical or functional properties, including diagnostic properties, to achieve the intended purpose as claimed by the manufacturer, thereby leading to clinical benefits to patients when used as intended by the manufacturer;
(53) "clinical benefit" means the positive impact of a device on a person's health, expressed as a meaningful, measurable, patient-relevant clinical outcome, including outcomes related to diagnosis or a positive impact on patient care; or for public health;
(54) “investigator” means a person responsible for conducting clinical research at a clinical research site;
(55) "informed consent": the subject's free and voluntary expression of his/her willingness to participate in a particular clinical trial after being informed of all aspects of the clinical trial relevant to the subject's decision to participate or, in the case of minors and incompetent persons, the permission or consent of their legally appointed representative for their inclusion in the clinical study;
(56) "ethics committee" means an independent body established in a Member State in accordance with the law of that Member State and empowered to issue opinions for the purposes of this Regulation, taking into account the views of non-specialists, in particular patients or patient organizations;
(57) "adverse effect" means any adverse medical event, unintended disease or injury, or adverse clinical sign, including an abnormal laboratory finding, in subjects, users or other persons in connection with a clinical trial, whether or not related to the investigational device ·
(58) "serious adverse event" means any adverse event resulting in any of the following:
| (in) | death, |
| (and) | serious deterioration of the person's health, resulting in any of the following: (i) life-threatening illness or injury; (ii) permanent impairment of body structure or a body function; (iii) hospitalization or extension of the patient's hospitalization; (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent damage to the structure of the body or a body function, (v) chronic disease; |
| (do) | fetal difficulties, fetal death or congenital physical or psychological injury or genetic defect. |
(59) "device defect": any deficiency in the identity, quality, durability, reliability, safety or performance of a research device, including malfunctions, errors of use or insufficient information provided by the manufacturer
60) "post-market surveillance" means all activities carried out by manufacturers in cooperation with other economic operators to establish and update a systematic process for proactively collecting and reviewing experience from devices they place on the market. on the market or put into service to identify any need for immediate implementation of the necessary corrective or preventive measures
(61) "market surveillance" means the activities carried out and the measures taken by the competent authorities to check and ensure that the equipment meets the requirements of the relevant Union harmonization legislation and does not endanger health, safety or other aspects of public interest; PROTECTION?
62) "recall" means any action aimed at obtaining the return of a device that has already been made available to the end user;
(63) 'withdrawal' means any measure intended to prevent a device from being made further available in the supply chain on the market;
(64) "incident": any malfunction or deterioration of the characteristics or performance of a device available on the market, including errors of use due to ergonomic features, as well as any deficiency in the information provided by the manufacturer and any unwanted side effect;
(65) "serious incident" means any incident which directly or indirectly led, could have led or could have led to any of the following:
| (in) | the death of a patient, user or other person; |
| (and) | the temporary or permanent serious worsening of a patient's condition, the state of health of the user or other person, |
| (do) | serious threat to public health; |
67 in humans, or which is unusual or unexpected for the given place and time;
(67) "corrective action" means the action taken to eliminate the cause of a potential or actual non-compliance or other undesirable situation;
69
(69) "field safety notice" means a notice sent by a manufacturer to users or customers in connection with a safety corrective action in the field;
(70) "harmonised standard" means a European standard as defined in Article 2(1)(c) of Regulation (EU) No
(71) "common specification" (CS) means a set of technical and/or clinical requirements, other than a standard, which allow compliance with the legal obligations applicable to a device, procedure or system.