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. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device.
Source: [MDR 745]
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.
Source: [MDR 745]
High German independent federal authority within the Federal Ministry of Health.
Plan that explains the biological assessment strategy that the manufacturer must perform on the medical device.
Report summarizing the strategy and results of biological analyzes performed on the medical device according to a pre-established plan.
Assessment to demonstrate the biological safety of a medical device.
Authority responsible for supervising the application of current regulations, competent in the classification and evaluation of data concerning incidents that can cause or have caused death or a serious deterioration in the health of the patient or user.
Preventive and/or corrective actions taken by the manufacturer to eliminate the causes of a potential and/or identified non-compliance or any undesirable situation with the aim of preventing it from happening.
A document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation.
Source: [MDR 745]
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.
Source: [MDR 745]
Plan that explains the clinical evaluation strategy that the manufacturer must perform on the medical device.
Report summarizing the strategy and results of clinical analyzes performed on the medical device according to a pre-established plan.
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.
Source: [MDR 745]
Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.
Source: [MDR 745]
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.
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices.
Source: [MDR 745]
Substance or preparation that in puntctual or prolonged contact with the human body over time, can cause malignances, genetic alterations and/or have harmful effects on the sexual functions or fertility of adults, as well as on the development of progeny.
Itlalian classification of medical devices, adopted by European commission as a suitable nomenclature for the implementation of EUDAMED.
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.
Source: [MDR 745]
Document issued by manufacturer which certifies as the requirements of the current regulation are fulfilled.
Declaration drawn up and signed by the authors of documentation aimed to demonstrate conformity of the medical device pursuant to technical/scientific aspects.
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.
Source: [MDR 745]
Requirements that a medical device has to respect to obtain the CE marking and subsequent commercial immission.
A manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3).
Source: [MDR 745]
Database that integrates various electronic systems in order to observe and observe information regarding devices on the market and economic operators, certain aspects of conformity assessment, notified bodies, certificates, clinical investigations, supervision and surveillance of the Market.
US government agency that deals with the regulation of food, pharmaceutical and medical products entering the aforementioned market. Divided into 8 sections, the medical is entrusted to the Center for Radiological Devices and Health (CDRH).
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. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights.
Source: [MDR 745]
Methodology used to analyze the failure or defect modes of a process, product and / or system. Used in the risk management process.
Action taken by the manufacturer to reduce the risk of death or serious deterioration in the health of users who come into contact with a medical device.
Communication issued by the manufacturer and/or representative to customers and/or users in relation to an FSCA.
Documents requiring behavioral requirements, drafting documents, requirements etc.
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.
Source: [MDR 745]
Voluntary group of international representatives of medical regulatory authorities for Europe, USA, Canada, Japan and Australia, whose goal was the standardization of device regulation worldwide.
Nomenclature used internationally. Divided into 12 categories, it contains approximately 7000 primary terms and 10000 synonyms for medical devices. Recently it has been modified and countless new codes created.
Manufacturers must demonstrate compliance with the GSPR, that provide broad, high-level criteria for safety and performance applicable to design, production, and postproduction aspects, throughout the lifecycle of all MD before putting this on the market.
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.
Source: [MDR 745]
The Ministry of Health, specifically Office 3 – General Directorate of Medical Devices and Pharmaceutical Service is the competent Italian authority in biomedical and pharmaceutical matters.
It is a voluntary group of medical device regulators from around the world who have come together to strengthen the strong work done by GHTF and to accelerate the harmonization and convergence of international medical device regulations.
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.
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.
Source: [MDR 745]
Any natural or legal person established within the Union that places a device from a third country on the Union market.
Source: [MDR 745]
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.
Source: [MDR 745]
Any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.
Source: [MDR 745]
It is a documented process that verifies that all aspects of structures, services and equipment that affect the quality of the product comply with the approved design specifications and that the piece of equipment or tool has been delivered correctly. Installed correctly.
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, solely or principally for the purpose of providing information on one or more of the following:
(a) concerning a physiological or pathological process or state;
(b) concerning congenital physical or mental impairments;
(c) concerning the predisposition to a medical condition or a disease;
(d) to determine the safety and compatibility with potential recipients;
(e) to predict treatment response or reactions;
(f) to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.
Source: [IVDMR 746]
A combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.
Source: [MDR 745]
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.
Source: [MDR 745]
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:
— 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, including organ, blood and tissue donations, 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.
The following products shall also be deemed to be medical devices:
— devices for the control or support of conception; — products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this poin.
Source: [MDR 745]
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);.
Source: [MDR 745]
Group that advises the Commission and assists the Commission and Member States in ensuring harmonized application of the Medical Device Regulations (EU) 2017/745 and 2017/746.
New regulation on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
The post-marketing surveillance system is designed to actively, systematically collect, record and analyze the relevant data on the quality, performance and safety of a device during its entire life, to draw the necessary conclusions and to determine, implement and monitor any preventive and corrective actions.
A conformity assessment body designated in accordance with this Regulation.
Source: [MDR 745]
La persona fisica indica un individuo identificato da nome e cognome, mentre la persona giuridica è l’insieme organizzato di persone e di beni che viene considerato un soggetto di diritto
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.
A natural or legal person who relies on already CE certified products of an OEM and that repackage the device under his own name or trademark.
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.
Source: [MDR 745]
It is a documented process that verifies the correct functioning of the machine in the workplace.
Iterative management method that is used for the control and continuous improvement of processes and products.
Continuous process that updates the clinical evaluation and is covered in the manufacturer’s post-marketing surveillance plan.
Source: [MDR 745]
Plan that guarantees the updating of the clinical evaluation prepared by the manufacturer.
Summary of the results obtained following a PMCFP.
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.
Source: [MDR 745]
Verifies that the equipment as part of the production process respects the reproducible, constant and appropriate productivity criterion using the predefined performance parameters.
Agreement defined between the parties and designed to identify all the activities and responsibilities aimed at ensuring the fulfillment of the quality objectives.
Set of all related and interdependent activities that influence the quality of a product or service.
Systematic use of available information to identify hazards and estimate risk.
Source: [ISO 14971]
Repertorire of DM marketed in Italy in order to allow both economic and political assessments.
Systematic application of management policies, procedures and practices to risk analysis, assessment, control and monitoring tasks.
Source: [ISO 14971]
Set of records and other documents produced by risk management.
Source: [ISO 14971]
Plan that explains the risk assessment strategy that the manufacturer carries out on the DM.
Report summarizing the strategy and final results of the risk management process.
Source: [ISO 14971]
A combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.
Source: [MDR 745]
Document prepared to clarify and explain what to do in any business process.
Number issued by the competent authority to the manufacturer, authorized representative or importer and useful for conformity assessment and access to EUDAMED.
Source: [MDR 745]
Document drawn up by the manufacturer to describe, identify and report all the salient aspects related to the clinical performance of the DM in question.
Document approved by recognized bodies that provides the rules, guidelines or technical specifications for carrying out an activity.
Program or set of programs that can be used on a data processing system and become DM if they conform to their definition.
A device that is intended to be used on one individual during a single procedure.
Source: [MDR 745]
Documentation prepared by the manufacturer to demonstrate compliance with applicable requirements and assessed by bodies responsible for issuing the CE certification.
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.
Source: [MDR 745]
A unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.
Source: [MDR 745]
A numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.
Source: [MDR 745]
Nomenclature created by Emergency Care Research Institute and officially adopted by different nations for the identification of MD.
Theoretical/practical activities aimed at ensuring that no process / product requirements have been left out and that the process/product functions in such a way as to meet predefined expectations.