ACCESSORY FOR A MEDICAL DEVICE
A product which, although not itself a Medical Device, is intended by the Manufacturer to be used with one or more specific Medical Devices, in particular to allow the latter to be used in accordance with their intended use, or to specifically and directly assist the medical functionality of the Medical Device(s) in relation to their intended use.
ACCESSORY FOR IN VITRO DIAGNOSTIC MEDICAL DEVICE
A product which, although not itself an in vitro diagnostic medical device, is intended by the manufacturer to be used with one or more specific in vitro diagnostic medical device, in particular to enable the In Vitro Diagnostic Medical Devices to be used in accordance with their intended use, or to specifically and directly assist the medical functionalities of the device or of the Medical Devices in relation to their intended use.
Any adverse clinical event, inappropriate patient management decision, unintentional disease or injury, or adverse clinical sign, including abnormal laboratory findings, occurring in subjects, users or other persons in a performance study/clinical investigation, whether or not the event is related to the device under consideration in the performance study/investigation.
AMD (Active Medical Device)
Any device whose operation depends on a source of energy other than that generated by the human body for that purpose or by gravity and which acts by modifying the density of that energy or converting it. Devices intended to transmit energy, substances or other elements between an active device and the patient without significant modification shall not be considered as active devices. A software is also considered an active device.
Ability of an in vitro diagnostic medical device to detect or measure a specific analyte correctly.
AR (Authorised Representative)
Any natural or legal person established in the European Union who has received and accepted from the Manufacturer, located outside the European Union, a written mandate authorising him or her to act on behalf of the Manufacturer in relation to certain activities in relation to the Manufacturer’s obligations under MDR (EU) 2017/745 and IVDR (EU) 2017/746.
Is the primary identifier of a device model. It is the DI assigned at the unit of use level of the device. It is the main key information for registrations in the UDI database and is indicated in the relevant EU certificates and declarations of conformity.
BEP (Biological Evaluation Plan)
A plan setting out a series of activities that the Manufacturer must perform on the Medical Device to assess and measure the risk associated with hazardous situations.
BER (Biological Evaluation Report)
A report summarising the strategy and results of the biological tests performed on the Medical Device according to a pre-established plan.
BEV (Biological Evaluation)
An assessment to demonstrate the biosafety of a Medical Device.
CA (Competent Authority)
Authority responsible for enforcing the rules in place and for classifying and evaluating data concerning accidents which may cause or have caused death or serious deterioration in the health of a patient or user.
Material reference measurement used for the calibration of an in vitro diagnostic medical device.
CAPA (Corrective Action and Preventive Action)
Corrective Action is the action that is taken, once the non-conformity has been resolved or at the same time, to prevent the recurrence of the same nonconformity in the future. With Preventive Action, instead, we try to prevent the occurrence of a possible non-conformity that has not yet occurred (or to manage an improvement).
CDP (Clinical Development Plan)
A document presenting the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation.
CE – European Certification
“CE conformity marking” or “CE marking”. It is a marking by which a Manufacturer indicates that a device complies with the applicable requirements set by the MDR (EU) 2017/745 and IVDR (EU) 2017/746 Regulations and other applicable European Union harmonisation legislations that entail its application.
CEP (Clinical Evaluation Plan)
A plan outlining the clinical assessment strategy that the Manufacturer carries out on the Medical Device.
CER (Clinical Evaluation Report)
Report summarising the strategy and results of clinical tests performed on the Medical Device according to a pre-established plan.
CEV (Clinical Evaluation)
A systematic and planned process of continuously generating, collecting, analysing and evaluating clinical data related to a device to verify its safety and performance, including clinical benefits, when used as intended by the Manufacturer.
CI (Clinical Investigation)
Any systematic investigation involving one or more human subjects to assess the safety or performance of a device.
The positive impact of a device on a person’s health, expressed in terms of a significant, measurable and patient-relevant clinical outcome, including the diagnostic outcome, or a positive impact on patient management or public health.
Safety or performance information derived from the use of a device and derived from:
- clinical investigations relating to the device in question;
- clinical investigations or other studies published in the scientific
literature concerning a device which can be shown to be equivalent to the
device in question;
- reports published in the peer-reviewed scientific literature on other
clinical experiences relating to the device concerned or to a device which can
be shown to be equivalent to the device concerned;
- clinically relevant information from post-marketing surveillance, in
particular post-marketing clinical follow-up.
The clinical data and performance assessment results of a device of sufficient quality and quantity to allow a qualified assessment of the ability of the device to deliver the intended clinical benefit and safety when used as intended by the manufacturer.
CLINICAL PERFORMANCE according to IVDR (EU) 2017/746
The ability of a device to deliver results in relation to a particular disease condition or physiological or pathological process depending on the target population and the intended user.
CLINICAL PERFORMANCE according to MDR (EU) 2017/745
The ability of a device, due to direct or indirect medical effects, arising from its technical or functional characteristics, including diagnostic characteristics, to achieve the intended use declared by the Manufacturer, thereby providing a clinical benefit to patients, when used as intended by the Manufacturer.
CMD (Custom-Made Device)
Any device specially manufactured on the basis of a written prescription issued by any person authorised by national law by virtue of his professional qualification, which indicates, under the responsibility of that person, the specific design characteristics, and which is intended to be used only for a given patient exclusively for the purpose of meeting his individual conditions and needs.
CMR chemicals (Carcinogenic, mutagenic and reprotoxic chemicals)
A substance which, in contact with the human body, may cause neoplasms, gene alterations and/or have harmful effects on adult sexual function or fertility and on the development of offspring.
The ability of a device, including software, when used in conjunction with one or more other devices, in accordance with its intended use, to:
the performance without losing or impairing the ability to function as
integrated and/or function without any need for modification or adaptation of
any part of the combined devices; and/or
(c) be used together with other devices without conflict/interference or
The procedure for demonstrating whether the requirements of the MDR (EU) 2017/745 Regulations and of the IVDR (EU) 2017/746 Regulations relating to a device have been met.
CONFORMITY ASSESSMENT BODY
A body carrying out conformity assessment activities, including calibration, testing, certification and inspection, on behalf of third parties.
A substance, material or article intended by the Manufacturer to be used to verify the performance characteristics of an in vitro diagnostic medical device.
CS (Common Specifications)
A set of technical and/or clinical requirements, other than a standard, which enable the legal obligations applicable to a device, process or system to be met.
DEFECT OF A DEVICE
Any deficiency in the identity, quality, durability, reliability, safety or performance of a device intended for performance study or clinical investigation, including malfunction, misuse or inadequate information provided by the Manufacturer.
A “non-cellular substance” extracted from human or animal tissues or cells by a manufacturing process. In this case, the final substance used to manufacture the device does not contain cells or tissues.
DETERMINATION OF THE BENEFIT/RISK RATIO
Analysis of all assessments of the benefits and risks, if any, relevant to the use of the device for its intended use, when used in accordance with the intended use indicated by the manufacturer.
DEVICE UNDER INVESTIGATION
A device that is being evaluated in a clinical investigation.
The ability of an in vitro diagnostic medical device to recognise the presence of a target marker associated with a specific disease or condition.
The ability of a device to recognise the absence of a target marker associated with a particular disease or condition.
Any natural or legal person in the supply chain, other than the Manufacturer or the Importer, who makes a device available on the market until it is put into service.
DoC (Declaration of Conformity)
A document drawn up by the manufacturer certifying that the requirements of the current regulations are being met in relation to the device concerned.
DoI (Declaration of Interests)
Declaration drawn up and signed by the authors of said document demonstrating conformity of the Medical Device in technical/scientific terms.
EO (Economic Operator)
A Manufacturer, an Authorised Representative, an Importer, a Distributor or the natural and/or legal person who puts into service, makes available and/or makes available on the market a Medical Device.
EUDAMED – European Database of Medical Devices
Database integrating different electronic systems in order to collect and process information on devices on the market and Economic Operators, certain aspects of conformity assessment, Notified Bodies, certificates, clinical investigations, market surveillance and surveillance.
EXPERIMENTER according to the IVDR (EU) 2017/746
A person responsible for conducting a performance study at a performance study site.
EXPERIMENTER according to MDR (EU) 2017/745
A person responsible for conducting a clinical investigation at a clinical investigation site.
FMEA (Failure Mode and Effect Analysis)
Methodology used to analyse the failure or defect modes of a process, product and/or system. It is used in the risk management process.
Any device misrepresenting its identity and/or origin and/or its CE marking certificates or documents relating to the procedures for the CE marking. This definition does not include unintentional non-conformity and does not cover infringements of intellectual property rights.
FSCA (Field Safety Corrective Action)
Action taken by the Manufacturer to reduce the risk of death or serious deterioration of health status of users coming into contact with a Medical Device.
FSN (Field Safety Notice)
Communication sent by the Manufacturer and/or the authorised representative to customers and/or users in relation to an FSCA.
GDG (Generic Device Group)
A series of devices with the same or similar intended use or sharing the same technology, so that they can be classified generically without taking into account specific characteristics.
GMDN (Global Medical Device Nomenclature)
Nomenclature used at international level. Divided into 12 categories, it contains approximately 7000 primary terms and 10,000 synonyms for Medical Devices. It has recently been amended and countless new codes have been created.
GRAVE THREAT TO PUBLIC HEALTH
An event which could result in an imminent risk of death, a serious deterioration in the health of a person or a serious disease which may require immediate corrective action and which may result in a significant rate of human morbidity or mortality or which is unusual or unexpected at that time and place.
GSPR (General Safety and Performance Requirements)
Manufacturers must demonstrate compliance with the GSPR, which provides comprehensive and high-level safety and performance criteria applicable to design, production and post-production aspects throughout the life cycle of all devices before placing them on the market.
Document providing recommendations for behaviour, document writing, requirements etc.
A European standard adopted on the basis of a request from the European Commission for the purpose of applying European Union harmonisation legislation.
An organisation whose main purpose is the care or treatment of patients or the promotion of public health.
IFU (Instructions For Use)
Information provided by the manufacturer to inform the user of the intended and correct use of a device and of any precautions to be taken.
IMPMD (Implantable Medical Device)
Any device, including those which are partly or wholly absorbed, designed to:
completely implanted in the human body, or
– to replace
an epithelial surface or the ocular surface by clinical intervention and to
remain there after the operation.
Any device intended to be partially introduced into the human body by
clinical intervention and to remain there after the intervention for a period
of at least 30 days shall also be considered an implantable device.
Any natural or legal person established in the European Union who places on the European Union market a device originating in a third country.
The free and voluntary expression of an individual’s willingness to participate in a particular performance study/clinical investigation after being informed of all aspects relevant to his or her decision to participate or, in the case of minors and incapable persons, the authorisation or agreement of their legally appointed representatives to include them in the performance study/clinical investigation.
The intended use of a device as indicated by the manufacturer on the label, in the instructions for use or in the material or in the promotion or sale statements and as specified by the manufacturer in the clinical evaluation.
The ability of two or more devices, including a software, from the same or different manufacturers to:
information and use the information exchanged for the purpose of the proper
performance of a specific function without changing the content of the data;
communicate with each other; and/or
(c) operate jointly as intended.
INTERVENTIONAL STUDY OF THE CLINICAL PERFORMANCE OF AN IN VITRO DIAGNOSTIC MEDICAL DEVICE
A clinical performance study where test results may influence patient management decisions and/or be used to guide treatment.
IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PERFORMANCE STUDIES
An in vitro diagnostic medical device intended by the manufacturer to be used in a performance study. Devices intended to be used for research purposes without any medical purpose shall not be considered as devices intended for performance studies.
IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR SELF-TESTING
Any in vitro diagnostic medical device intended by the Manufacturer for use by lay users, including devices used for testing services offered to said users through Information Society services.
INVMD (Invasive Device)
Any device which penetrates partially or entirely into the body through an orifice of the body or the surface of the body.
IQ (Installation Qualification)
A documented process to verify that all aspects of facilities, services and equipment affecting product quality comply with the approved design specifications and that the piece of equipment or tool has been properly delivered and installed.
IVD (In Vitro Diagnostic) – In vitro diagnostic medical device
Any in vitro diagnostic medical device consisting of a reagent, a reactive product, a calibrator, a control material, a kit, an instrument, an apparatus, a part of equipment, a software or a system, used alone or in combination, intended by the Manufacturer for in vitro use for the examination of samples from the human body, including donated blood and tissues, solely or primarily for the purpose of providing one or more of the following information:
(a) on a
physiological or pathological process or condition;
congenital physical or intellectual disability;
susceptibility to a clinical condition or disease;
determine security and compatibility with potential recipients;
predict response or reactions to treatment;
(f) to define
or monitor therapeutic measures.
Sample containers are also considered In Vitro Diagnostic Medical Devices.
IVDR (EU) 2017/746
Regulation on In Vitro Diagnostic Medical Devices, published on May 5th 2017 and entered into force on May 26th 2017. It lays down the rules and requirements for the placing on the market, making available and putting into service of In Vitro Diagnostic Medical Devices from May 26th 2022.
KIT – Procedural Kit
Combination of jointly packaged products placed on the market for use for a specific medical purpose.
A person who does not have formal qualifications in a relevant field of healthcare or in a medical discipline.
Written, printed or graphic information appearing on the device itself or on the packaging of each unit or on the packaging of several devices.
The legal person is the organised body of persons and property which is considered to be a legal entity.
MAKING AVAILABLE ON THE MARKET: the supply of a device, excluding devices intended for performance studies, for distribution, consumption or use on the European Union market in the course of a commercial activity, whether for consideration or free of charge.
Any natural or legal person who Manufactures or recovers a device, or has it designed, manufactured or recovers, and markets it under his name or trademark.
The activities carried out and measures taken by public authorities to verify and ensure that devices comply with the requirements set out in the relevant European Union harmonisation legislation and do not jeopardise the protection of health and safety or any other aspect of public interest.
MD (Medical Device)
Any instrument, appliance, software, implant, reagent, material or other article, intended by the Manufacturer to be used on humans, alone or in combination, for one or more of the following specific medical uses:
prevention, monitoring, forecasting, prognosis, treatment or mitigation of
monitoring, treatment, mitigation or compensation of an injury or disability,
replacement or modification of the anatomy or of a physiological or
pathological process or condition,
– to provide
information by in vitro examination of samples taken from the human body,
including donated blood and tissues, which do not exercise in or on the human
body the principal action for which it is intended by pharmacological,
immunological or metabolic means, but whose function may be assisted by such
products are also considered Medical Devices:
– devices for
the control of conception or support of conception,
– products specifically intended for the cleaning, disinfection or sterilisation of the devices referred to in Article 1, paragraph 4 of the MDR.
MDCG (Medical Device Coordination Group)
Group that provides advice to the European Commission and assists the Commission and Member States in ensuring a harmonised application of the MDR (EU) 2017/745 and of the IVDR (EU) 2017/746.
MDR (EU) 2017/745
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 date of full application of the MDR (EU) 2017/745 was May 26th 2021.
MDSAP (Medical Device Single Audit Program)
Program that allows organisations recognised and accredited by the Regulatory Authorities of the five member countries (U.S.A., Canada, Brazil, Japan and Australia) to conduct a single audit of Medical Device Manufacturers to verify that they meet the requirements of the Quality System (GMP: Good Manufacturing Practice) in the same countries.
MDVS (Medical Devices Vigilance System)
Is a post-market surveillance system capable of actively and systematically collecting, recording and analysing relevant data on the quality, performance and safety of a device throughout its life, of drawing the necessary conclusions and of identifying, implementing and monitoring possible preventive and corrective actions.
NB (Notified Body)
A conformity assessment body designated in accordance with a regulation.
NCD (National Classification of Medical Devices)
Italian Classification of Medical Devices, adopted by the European Community as a nomenclator suitable for the implementation of the EUDAMED database.
NEGATIVE PREDICTIVE VALUE (NPV)
The ability of an in vitro diagnostic medical device to separate true negative results from false negative results for a given attribute in a given population.
A natural, derived or manufactured material containing particles in the free, aggregated or agglomerated state, and in which, for at least 50% of the particles in the numerical dimensional distribution, one or more external dimensions are between 1 nm and 100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions of less than 1 nm are considered nanomaterials.
Without the ability to metabolise or multiply.
OEM (Original Equipment Manufacturer)
Natural or legal person who manufactures or recovers a device, or has it designed, manufactured or recovered, and markets it under their trade name or trademark.
OQ (Operational qualification)
Documented process that verifies the correct functioning of the machine in the working environment.
A tiny part of matter with defined physical limits.
PDCA (Plan-Do-Check-Act) –
Iterative management method which is used for the continuous monitoring and improvement of processes and products.
The ability of a device to achieve the intended use declared by the manufacturer.
PERFORMANCE OF AN IN VITRO DIAGNOSTIC MEDICAL DEVICE
The ability of an in vitro diagnostic medical device to lend itself to its intended use, as declared by the Manufacturer. This refers to the analytical and, where appropriate, the clinical performance supporting the intended use.
Evaluation and analysis of data to establish or verify the scientific validity, analytical performance and, where appropriate, clinical performance of a device.
A study intended to establish or confirm the analytical or clinical performance of an in vitro diagnostic medical device.
The physical person indicates an individual identified by name and surname.
PLACEMENT IN SERVICE
The stage at which a device, excluding devices intended for performance studies, has been made available to the last user as being ready for first use on the European Union market according to its intended use.
PLACEMENT ON THE MARKET
When a device is first made available, excluding devices intended for performance studies, on the market of the European Union.
PLAN OF CLINICAL INVESTIGATION
A document explaining the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation.
PLAN OF PERFORMANCE STUDY A document explaining the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study.
PMCF (Post-Market Clinical Follow-up)
A continuous process updating the clinical assessment, it is addressed in the Manufacturer’s post-marketing surveillance plan.
PMCFP (Post-Market Clinical Follow-up Plan)
Plan to ensure that the clinical assessment prepared by the Manufacturer is up to date.
PMCFR (Post-Market Clinical Follow-Up Report)
Report on the results achieved following a PMCFP.
PMPF (Post-Market Performance Follow-Up)
A continuous process updating the performance assessment and is addressed in the Manufacturer’s post-market surveillance plan.
PMPFP (Post-Market Performance Follow-Up Plan)
Plan to ensure that the manufacturer’s performance assessment is up-to-date.
PMPFR (Post-Market Performance Follow-Up Report)
Report of the results obtained following the Follow-up Plan Up of Post-Marketing performance.
PMS (Post-Market Surveillance)
All activities carried out by Manufacturers in collaboration with other Economic Operators aimed at establishing and maintaining a systematic procedure to proactively collect and analyse the experience acquired on the devices they place on the market, make available on the market or put into service, in order to identify any need for immediate corrective or preventive action.
The probability that a person who tested positive with an in vitro diagnostic medical device will have a particular disease under investigation or that a person who tested negative in such a test will not have a particular disease.
POSITIVE PREDICTIVE VALUE (PPV)
The ability of an in vitro diagnostic medical device to separate true positive from false positive results for a given attribute in a given population.
PSUR (Periodic Safety Update Report)
Report foreseen for Class IIa, IIb and Class III Medical Devices summarising the results and conclusions of analyses of data collected in post-marketing surveillance on the basis of the post-marketing surveillance plan.
QMS (Quality Management System)
Set of all related and interdependent activities affecting the quality of a product or service.
QTA – (Quality Technical Agreement)
An agreement between the parties identifying all activities and responsibilities to ensure that the quality goals are met.
RA (Risk Analysis)
Systematic use of available information to identify hazards and estimate risk.
RECALL FROM THE MARKET
Any measure aimed at obtaining the return of a device which has already been made available to the final user.
A process carried out on a used device to enable its safe reuse, including cleaning, disinfection, sterilisation and associated procedures, as well as testing and restoration of the technical and functional safety of the used device.
For the purposes of the definition of the Manufacturer, the complete reconstruction of a device already placed on the market or put into service, or the manufacture of a new device from used devices, in order to bring it into conformity with Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746, together with the imparting of new life to the refurbished device.
The combination of the probability of damage occurring and the severity of the damage.
RM (Risk Management)
Systematic application of management policies, procedures and practices to the tasks of risk analysis, assessment, control and monitoring.
RMF (Risk Management Files)
Set of records and other documents produced through risk management.
RMP (Risk Management Plan)
A plan that sets out the risk assessment strategy that the manufacturer carries out on the device.
RMR (Risk Management Report)
Report summarising the strategy and final results of the risk management process.
A communication sent by a Manufacturer to users or customers in relation to a safety corrective action.
SaMD (Software as a Medical Device)
Software intended to be used for one or more medical purposes without being part of a medical hardware device.
A device, whether under vacuum or not, specifically designed by the manufacturer to directly receive the human body sample and to store it for in vitro diagnostic examination.
SECURITY CORRECTIVE ACTION
Corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of serious accidents in relation to a device made available on the market.
SERIOUS ADVERSE EVENT
Any adverse event which has had any of the following consequences:
decision about the management of the patient which caused the death of the test
person or put him or her in imminent danger or caused the death of his or her
(c) a serious
deterioration in the health of the person tested or of the recipient of the
donations or test materials, resulting in:
life-threatening disease or injury;
permanent damage to a bodily structure or function;
need for hospitalisation of the patient or its extension;
or surgical intervention to prevent a life-threatening disease or injury or
permanent damage to a bodily structure or function;
(v) a chronic
distress, foetal death or a congenital physical or intellectual malformation or
Any accident which, directly or indirectly, has caused, may have caused or may cause any of the following consequences:
(a) the death
of a patient, user or other person;
deterioration, whether temporary or permanent, of the state of health of the
patient, the user or another person;
(c) a serious threat to public health.
SOP (Standard Operating Procedure)
Document written to clarify and explain what to do in any business process.
Any person, company, institution or organisation which assumes responsibility for initiating, managing and managing the funding of a clinical investigation.
SRN (Single Registration Number)
A number issued by the competent authority to the manufacturer, authorised representative or importer and useful for conformity assessment and access to EUDAMED.
SSCP (Summary of Safety and Clinical Performance)
A document drawn up by the Manufacturer to describe, identify and report all salient aspects related to the clinical performance of the device under examination.
STD – Standard
A document approved by recognised organisations providing rules, guidelines or technical specifications for carrying out an activity.
A person participating in a clinical investigation.
SUD (Single Use Device)
A device intended to be used on a person during a single procedure.
SW – Software
Program or set of programs that can be used on a data processing system and become devices if they conform to their definition.
SYSTEM OF MEDICAL DEVICES
A combination of products, whether or not packaged together, which are intended to be interconnected or combined to achieve a specific medical purpose.
TD (Technical Documentation)
Documentation drawn up by the Manufacturer to demonstrate compliance with the applicable requirements and evaluated by bodies responsible for issuing the CE certification.
UDI (Unique Device Identification)
Numeric or alphanumeric character set created on the basis of internationally accepted device identification and coding standards. It allows the unambiguous identification of a specific device on the market. The UDI is composed of the UDI-DI and the UDI-PI.
UDI-DI (Device Identifier)
A unique numeric or alphanumeric code specific to a device model and also used as an “access key” to information stored in a UDI database.
UDI-PI (Production Identifier)
Numeric or alphanumeric code identifying the unit of production of the device. The different types of UDI-PI include the serial number, the batch number, the software identification and the date of manufacture or expiration or both.
Any healthcare professional or lay user using a device.
V&V (Verification and Validation)
Theoretical/practical activities to ensure that no process/product requirements have been overlooked and that the process/product functions meet predefined expectations.
WITHDRAWAL FROM MARKET
Any measure preventing the further making available on the market of a device in the supply chain.