- accessory for a medical device
means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
- active device
means 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.
- Active device intended for diagnosis and monitoring
means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.
- Active therapeutic device
means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.
- adverse event
means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;
- authorised representative
means 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;
- benefit-risk determination
means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;
- Body orifice
means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.
- Central circulatory system
means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior.
- Central nervous system
means the brain, meninges and spinal cord.
- clinical benefit
means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;
- clinical data
means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
- clinical evaluation
means 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 evidence
means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;
- clinical investigation
means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;
- clinical investigation plan
means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;
- clinical performance
means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;
- common specifications
(CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
- conformity assessment
means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;
- conformity assessment body
means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;
- corrective action
means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;
- custom-made device
means 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.
- derivative
means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process.
- device deficiency
means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer;
- distributor
means 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
means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3);
- ethics committee
means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;
- falsified device
means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures.
- field safety corrective action
means 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;
- field safety notice
means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;
- generic device group
means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
- harmonised standard
means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
- health institution
means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;
- implantable device
means any device, including those that are partially or wholly absorbed, which is intended: by clinical intervention and which is intended to remain in place after the procedure.
- importer
means any natural or legal person established within the Union that places a device from a third country on the Union market;
- incident
means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;
- informed consent
means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation;
- Injured skin or mucous membrane
means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound.
- instructions for use
means 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;
- intended purpose
means 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;
- invasive device
means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body;
- investigational device
means a device that is assessed in a clinical investigation;
- investigator
means an individual responsible for the conduct of a clinical investigation at a clinical investigation site;
- label
means 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;
- lay person
means an individual who does not have formal education in a relevant field of healthcare or medical discipline;
- Long term
means normally intended for continuous use for more than 30 days.
- making available on the market
means 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;
- manufacturer
means 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 trade mark;
- market surveillance
means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;
- medical device
means 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 one or more of the following specific medical purposes: and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
- nanomaterial
means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm;
- non-viable
means having no potential for metabolism or multiplication;
- notified body
means a conformity assessment body designated in accordance with this Regulation;
- performance
means the ability of a device to achieve its intended purpose as stated by the manufacturer;
- placing on the market
means the first making available of a device, other than an investigational device, on the Union market;
- post-market surveillance
means 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;
- procedure pack
means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;
- putting into service
means 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;
- recall
means any measure aimed at achieving the return of a device that has already been made available to the end user;
- reprocessing
means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device;
- Reusable surgical instrument
means 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.
- risk
means the combination of the probability of occurrence of harm and the severity of that harm;
- serious adverse event
means any adverse event that led to any of the following:
- serious incident
means any incident that directly or indirectly led, might have led or might lead to any of the following:
- serious public health threat
means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;
- Short term
means normally intended for continuous use for between 60 minutes and 30 days.
- single-use device
means a device that is intended to be used on one individual during a single procedure;
- sponsor
means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation;
- subject
means an individual who participates in a clinical investigation;
- Surgically invasive device
means:
- system
means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;
- Transient
means normally intended for continuous use for less than 60 minutes.
- Unique Device Identifier
(‘UDI’) means 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;
- user
means any healthcare professional or lay person who uses a device;
- withdrawal
means any measure aimed at preventing a device in the supply chain from being further made available on the market;