Medical Device and IVD Terminology

Below you will find definitions for the most commonly used terms in the Medical Device and IVD industries.

Click on the + sign beside the term to open the definition.

If you are missing something from the list, don’t hesitate to get in touch with us.

More definitions can be found in EU MDR/IVDR Article 2 Definitions 

A   B   C   D   E   F   G   H   I   J   K   L   M   N   O   P   Q   R   S   T   U   V   X   Y  Z 

A

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).

An article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic 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 in vitro diagnostic medical device(s) in terms of its/their intended purpose(s). 

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. 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.  

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. 

Means the ability of a device to correctly detect or measure a particular analyte. Various parameters are assessed to evaluate analytical performance, see the definitions below: 

The ability to detect the presence of a target analyte. 

The ability to only detect the target analyte and no other substances. 

In the context of MDR/IVDR, an audit is a systematic, independent, and documented process for evaluating the conformity of medical device/IVD manufacturer’s quality management system (QMS) and related processes to the requirements of the MDR/IVDR. This process aims to verify that the QMS is effectively implemented and maintained, ensuring the safety and performance of medical devices/IVDs. The ability to only detect the target analyte and no other substances. 

An Authorized Representative under MDR/IVDR 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. 

B

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. 

Is a systematic assessment of the biological safety of a medical device or material that interacts with a human body. This evaluation includes identifying potential biological hazards, assessing associated risks, and determining their acceptability. 
All devices that will be in physical contact with a user shall undergo a biological evaluation.  Biological evaluations are performed according to the requirements in MDR and in ISO 10993. 

Is a structured document that outlines the strategy for assessing the biological safety of a medical device, in accordance with ISO 10993 series of standards and the risk management process outlined in ISO 14971 and is a crucial part of Technical Documentation (TD) required under MDR. 

Is a comprehensive document summarizing the biological safety assessment of a medical device, ensuring it poses no unacceptable risk to patient and is a key part of regulatory submission process for medical devices, demonstrating biocompatibility according to ISO 10993 standard series. It’s typically conducted within a risk management framework, as outlined in ISO 10993-1 and ISO 14971 and integrates data from various sources, including chemical characterization, physical and mechanical testing, and biological testing, to assess the device’s compatibility with a human body. BEP is a mandatory part of device Technical Documentation (TD). 

C

Means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in MDR/IVDR Regulations and other applicable Union harmonisation legislation providing for its affixing. 

Is a mandatory certification mark for products sold within the European Economic Area (EEA) 

Means the positive impact of a device on the health of an individual, expressed in terms of meaningful, measurable, patient-relevant clinical outcome(s), included outcomes related to diagnosis, or a positive impact on patient management or public health.  

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 Evaluation is a requirement in the Medical Devices Regulation 2017/745 which requires that the demonstration of conformity with the General Safety and Performance Requirements must include a clinical evaluation. The level of clinical evidence and the depth of the clinical evaluation required to ensure both the safety and performance of the medical device shall be proportionate to the risk class of the device, as well as its characteristics and intended purpose. A clinical evaluation must follow a defined and methodologically sound procedure, and it shall follow a clinical evaluation plan. A clinical evaluation shall be thorough and objective and consider both favourable and unfavourable data. This is achieved by identifying, appraising, and analysing all available and relevant clinical data: 

  • The relevant scientific literature currently available    
  • The results of all available clinical investigations  
  • The clinical state of the art    

Historical data related to the device or similar devices 

A detailed document that outlines the systematic approach for evaluating a medical device’s safety and performance, serving a roadmap for gathering, analysing, and interpreting clinical data to demonstrate that the device meets regulatory requirements and performs as intended. CEP guides the development of Clinical Evaluation Report (CER) should be updated throughout the device’s lifecycle, especially with new data from post-market surveillance and is a mandatory part of device Technical Documentation. 

CEP key elements: Scope, Data Sources, Methodology, Safety and performance Requirements, Expected Outcomes.  

Is a comprehensive document summarizing the clinical evaluation of a medical device and assessing the device’s safety and performance based on clinical data, including data from clinical investigations, scientific literature, and post-market surveillance. The CEP aims to demonstrate that the device is safe and effective for its intended use. CEP should be updated throughout the device’s lifecycle as new data becomes available, and it is a mandatory part of device Technical Documentation. 
CEP key elements: a device description, a summary of the clinical background and relevant scientific literature, a detailed analysis of clinical data, an assessment of the device safety and performance based on the collected data, a benefit-risk analysis, demonstrating that the benefits of using the device outweigh the risks. 

Means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device. 
Clinical Investigations involve a structured approach, following a predefined plan or protocol to ensure reliable and reproducible results and the data collected are used to support the overall clinical evaluation of the device. 
NOTE “Clinical trial” or “clinical study” are synonymous with “clinical investigation”. 

Means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation. 

Document describing the design, execution, statistical analysis, and results of a clinical investigation of a medical device, detailing the study’s conduct, including subject demographics, data analysis, adverse event reporting, and overall conclusions on safety and performance. 

Means information concerning safety or performance that is generated from the use of a device and is sourced from the following: 

  • clinical investigation(s) of the device concerned, 
  • clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated 
  • reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated, 
  • clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up.  

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 the manufacture (MDR). 
Means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user (IVDR). 

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. 

Means a device which is essential for the safe and effective use of a corresponding medicinal product to: 

(a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product. or 
(b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions because of treatment with the corresponding medicinal product 

Means the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to: 
(a) perform without losing or compromising the ability to perform as intended, and/or 
(b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, 
and/or 
(c) be used together without conflict/interference or adverse reaction. 

Means action taken to eliminate the cause of a potential or actual non-conformity or another undesirable situation. 

A value above which the IVD result becomes unreliable. 

Custom-made device means any device specifically made in accordance with a written prescription of any person authorized 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 authorized person shall not be custom-made devices.  Means action taken to eliminate the cause of a potential or actual non-conformity or another undesirable situation. 

Signal generation by similar analytes. 

D

Is a document in which the manufacturer formally declares that their device meets all the relevant MDR/IVDR requirements for safety and performance, and it essentially certifies that the device is safe to be placed on the market and used for its intended purpose. This declaration is required for medical devices and IVDs to be legally placed on the market and is a key part of the CE marking process in the European Union, where it indicates that the device complies with applicable directives and regulations. 
The CE marking must be affixed in a manner that it is legible and cannot be removed easily from the product concerned. 

A systematic set of procedures that guide the design and development of medical devices to ensure that the developed products are safe and effective and meet their intended use requirements in compliance with applicable regulatory standards in addition to needs of the commercial customer, end user, and, as appropriate, the patient. 

Mandated by FDA in 1990 as part of the Safe Medical Devices Act. DHF is a formal, organized documentation of all the product design and development processes pertaining to a finished medical device. 
The creation of a DHF is the last step in the design controls process mandated by FDA in 21 CFR Part 820.  

Design input means the physical and performance requirements of a device that are used as a basis for device design. 

Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labelling, and the device master record. 

Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, assess the design’s ability to meet those requirements, and identify any potential problems. 
The design review process is a crucial part of the design control requirements for medical devices, as outlined in 21 CFR Part 820. It ensures that the device is developed to established standards and is safe and effective for its intended use.  Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labelling, and the device master record. 

Is the process of transitioning a device’s design from the design and development phase to production. It ensures that the design specifications are accurately translated into manufacturing specifications, enabling the device to be produced consistently and meet regulatory requirements.  

Validation activities are carried out to provide objective evidence that device specifications (outputs) conform with user needs and intended use(s).  
Note: design validation is not the same as process validation performed during the validation phase).  
Design validation answers the question: Did we design the right device? 

Is the process of confirming that the device’s design meets all specified requirements. Design verification may encompass development or engineering studies that are performed prior to production to confirm that the design outputs meet the design input requirements including the functional and operational specification. These verifications may also include pilot- and external technical performance testing of the product.  
Design verification answers the question: Did we design the device right? 

A compilation of all documentation required to manufacture a specific medical device from start to finish, including instructions for all manufacturing processes, drawings, documented specifications and labelling and packaging requirements. DMR is a key component of FDA Quality System Regulation and is detailed in 21 CFR Part 820.  

A compilation of records required by FDA as outlined in 21 CFR Part 820.184, detailing the production history of a finished medical device. Device History Record (DHR) includes all documentation related to manufacturing and tracking the device and demonstrates that the device was manufactured according to the established Device Master Record (DMR).  

Any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services.

NPT, also known as a point-of care testing (POCT) is any intended to perform diagnostic testing outside a laboratory environment, generally close to, or at the patient’s side and used by by a health professionals in various settings like emergency rooms, ambulances, or even in the patient’s home. 

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. 

E

Means a manufacturer, an authorized representative, an importer or a distributor. 

F

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. 

Means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action. 

for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device. 

G

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. 

Are essential criteria that medical devices and in vitro medical devices must meet to be marketed within the EU that ensure that devices are safe for users and patients, perform as intended, and meet specific quality standards. General Safety and Performance Requirements are set out in Annex I MDR and IVDR. Fulfilment of requirements is to be documented in a GSPR checklist. Is a systematic assessment of the biological safety of a medical device or material that interacts with a human body. This evaluation includes identifying potential biological hazards, assessing associated risks, and determining their acceptability. 
All devices that will be in physical contact with a user shall undergo a biological evaluation.  Biological evaluations are performed according to the requirements in MDR and in ISO 10993. 

H

Means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012. 

I

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.

Means the information provided by the manufacturer to inform the user of a device’s intended purpose and proper use of any precaution to be taken (MDR/IVDR definition) 
Package insert, portion of the accompanying information that is essential for the safe and effective use of a medical device or accessory directed to the user of the medical device (IFU definition according to ISO 20417) 

Means any natural or legal person established within the Union that places a device from a third country on the Union market.

Implantable device means 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 

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 (MDR)/ in the performance evaluation (IVDR). 

Any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. 

Is a product that is evaluated for its health and safety aspects as part of clinical investigation. 

Means 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. 

K

A set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof.

L

Refers to all information accompanying a medical device, including labels, instructions for use, and any other supportive information that is related to identification, technical description, intended purpose that ensures device safe use and performance use and can be easily understood by the intended user.

Note: shipping documents are not considered as a part of labelling.

An individual who does not have formal education in a relevant field of healthcare or medical discipline.

All phases in the life of a medical device, from the initial concept and design to manufacturing, distribution, use and eventual decommissioning or disposal.

It encompasses the entire journey of a medical device, emphasizing regulatory compliance, safety, and effectiveness throughout its lifespan.

The lowest amount of analyte that can be reliably detected.

The lowest amount of analyte that can be reliably measured.

M

Representatives from key positions in and outside the company, e.g., Top-level managers: board of directors, president, vice-president, CEOs, etc.

Means any natural or legal person who designs, manufactures, packages, labels, or fully refurbishes a device and makes it available for use/placing on the market under their own name, regardless of whether these operations are carried out by the person themselves or on their behalf by a third party.

Legal Manufacturer definition emphasizes the legal responsibility for ensuring the device meets all relevant regulatory requirements.

‘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:

  • 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 sterilization of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

The Medical Device Single Audit Program (MDSAP) was developed by a group of medical device regulators, the International Medical Device Regulators Forum (IMDRF), to allow third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2016 and their respective regulatory requirements. Medical Device Single Audit Program participants include USA, Canada, Australia, Japan, and Brazil. In Canada MDSAP is mandatory.

N

National competent authorities are organizations that have the legally delegated or invested authority, or power to perform a designated function, normally monitoring compliance with the national statutes and regulations.

A notified body is an organization designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required.

P

Means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device (IVDR).

Clinical evidence shall support the intended use of the device and be based on a continuous process of performance evaluation. Performance evaluation shall demonstrate the scientific validity, analytical performance and clinical performance of the device and it shall follow a performance evaluation plan. The clinical evidence derived from the performance evaluation shall provide scientifically valid assurance that the relevant safety and performance requirements of the IVD Regulation are fulfilled.

Means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose.

Means a study undertaken to establish or confirm the analytical or clinical performance of a device (IVDR)

Means a document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study.

Is a key role (Article 15 MDR/IVDR) within medical device companies responsible for ensuring regulatory compliance of devices who possesses the requisite expertise in the field of medical devices. 

Key aspects of the PRRC role include ensuring conformity of medical devices. ensuring that the technical documentation and EU Declaration of Conformity are drawn and kept up to date. The post-market surveillance obligations are compiled with in accordance with Article 10(10). the reporting obligations referred to in Articles 87-91 are fulfilled. in the case of investigational devices, the statement referred to in Section 4.1 of Annex XV, Chapter II is issued.

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.

How consistent the results are when the same sample is tested multiple times under the same conditions.

A combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.

Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications and quality attributes. This is achieved by establishing documented evidence that the process, when operated within established parameters, will perform effectively and reproducibly. Process validation must be included QMS as a core element.

Q

A quality management system (QMS) is defined as a formalized system that outlines an organization’s policies, processes, and procedures for achieving and maintaining quality in its products, services and operations. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

ISO 13485:2016 specifies requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements (MDR/IVDR). It includes the stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g., technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

R

A Record refers to documented information that provides evidence of activities, procedures and results related to the design, manufacturer, quality control, and distribution of a device, generated during performance of the activities specified in a SOP. A record can be a protocol, test result, technical documentation etc. Records are essential for maintaining product quality, ensuring patient safety, and demonstrating compliance with regulatory requirements throughout the device’s lifecycle.

The specification of the technical, user and regulatory requirements that are transformed into measurable, objective, and non-conflicting requirements on the product that include both functional and non-functional requirements, outlining how the device should operate, perform, and interact with its environment, as well as its safety and performance characteristics.

For reusable devices – a process carried out on a used device to allow its safe “reuse” including cleaning, disinfection, packaging and, when appropriate, the validated method of re-sterilization, and related procedures, as well as testing and restoring the technical and functional safety of the used device, meeting the same standards of safety and performance as a new device.

The MDR allows for reprocessing and further use of a single-use devices under specific conditions, primarily when permitted by national law and in accordance with Article 17 MDR.

Means a combination of the probability of occurrence of harm and the severity of that harm as defined in ISO 14971: 2019 – an international standard that provides a framework for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The risk management process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

Medical device classification is based on the intended purpose and risk of the device.

Classification according to MDR:

In the MDR, medical devices are divided into four classes (listed here from low to high-risk class) considering the intended purpose of the devices and their inherent risks: Class 1, Class IIa, Class IIb, Class III

The classification of medical devices is carried out according to Annex VIII of the MDR, guided by definitions, implementing rules and classification rules (from Rule 1 to 22).

The classification of medical devices in use by the EU medical device legislation is a risk-based system considering the vulnerability of the human body and the potential risks associated with the devices. The classification rules of the MDR correspond, to a large extent, to the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document GHTF/SG1/N77:2012. The classification aims to set an appropriate level of scrutiny for the conformity assessment of devices.

For Class IIa, IIb and III devices a Notified Body carries out the conformity assessment of the device.

In contrast, the conformity assessment procedure for Class I devices is carried out under the sole responsibility of the manufacturer, in view of the low level of vulnerability associated with such devices.

However, when Class I devices are placed on the market in a sterile condition, with a measuring function, or as reusable surgical instruments the manufacturer bears additional obligations as imposed by the MDR, such as the involvement of a Notified Body in the conformity assessment of the device.

These three classes are generally referred to as Class Is (sterile), Class Im (measuring function), Class Ir (reusable surgical)

Before applying the classification rules, the manufacturer should first determine if the product concerned, based on its specific medical purpose, falls in the scope of the MDR and, hence, qualifies as a medical device.

It is the ‘intended purpose’ that determines the risk class of the device, and

– not the accidental use of the device. Similarly, if a medical practitioner uses the device in a manner not intended by the manufacturer, this does not change the class of the device for the purpose of conformity assessment. However, if the normal clinical use of the device changes in time with evolving clinical practice, such that the intended purpose and classification of the device changes, this should be addressed by the manufacturer and the conformity of the device assessed for the new intended purpose.

– not the class assigned to other similar products. For instance, two sutures having the same material composition may well have different intended purposes.

Once the risk class of the device is defined, it must be documented in the technical documentation of the device together with a justification for the classification rule(s) applied in accordance with Annex VIII of the MDR.

See also classification of in vitro diagnostic (IVD) devices and qualification of medical devices.

Classification according to IVDR:

The IVDR establishes four risk classes considering the intended purpose of it and their inherent risks D, C, B, and A, with D being the highest risk class and A the lowest. There are altogether seven classification rules in Annex VIII, IVDR

Before applying the classification rules, the manufacturer should first determine if the product concerned, based on its specific medical purpose, falls in the scope of the IVDR and, hence, qualifies as a medical device in vitro diagnostic product. It is the ‘intended purpose’ that determines the risk class of the device.

Class B, C, and D IVDs will require certification by a Notified Body NB involvement as part of their conformity assessment. Only the lowest classification class A devices do not need NB involvement except for Class A devices that are sterile.

Also see. Risk Class (MD)

Is a structured and systematic process that focuses on identifying, assessing, and mitigating potential risk associated with the use of medical devices throughout their entire lifecycle. It’s a crucial aspect of ensuring the safety and effectiveness of medical device and requires a systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.

Which stands for Registration, Evaluation, Authorization and Restriction of Chemicals, is a European Union regulation focused on the safe use of chemicals

Means any measure aimed at achieving the return of a device that has already been made available to the end user.

Means any measure aimed at achieving the return of a device that has already been made available to the end user.

Restriction of Hazardous Substances legislation, specifically RoHS Directive, is a European Union regulation that restricts the use of certain hazardous substances in electrical and electronic equipment (EEE).

S

Means any adverse event that led to any of the following:

(a) death,

(b) serious deterioration in the health of the subject, that resulted in any of the following:

(i) life-threatening illness or injury,

(ii) permanent impairment of a body structure or a body function,

(iii) hospitalisation or prolongation of patient hospitalisation,

(iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,

(v) chronic disease,

(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect.

A device that is intended to be used on one individual during a single procedure.

This definition emphasizes the device’s intended purpose of being discarded after a single use.

Is a detailed written document that outlines the specific steps required to perform a task or process consistently and in compliance with regulations. SOPs are crucial for maintaining quality, ensuring consistency, and demonstrating adherence to regulatory requirements throughout the medical device lifecycle.

Specifications define the essential characteristics, materials, and performance criteria necessary for ensuring the device meets regulatory standards, safety requirements, and intended use. The requirements outlined in Specifications can concern a product, process, service, or test.

Specification is a controlled document, some examples are requirement specification, test specification, product specification, performance specification and drawings.

Medical device that is free from viable microorganisms and meet the requirements for sterility, outlined in EN 556-1 series standards.

A combination of two or more medical devices, either packaged together or not, that are intended to be connected, used together or combined to achieve a specific medical purpose.

T

A pre-defined structure or framework that helps medical device manufacturers organize and compile the necessary documentation for regulatory compliance. A Template is a way to ensure that records are created according to a specific SOP ensuring all required information is included and formatted consistently, which is crucial for demonstrating adherence to MDR/IVDR.

In project management, a tollgate meeting, also known as a tollgate review, is a structured checkpoint where the management/board follows up the project and decides whether a project can proceed to a next stage. These meetings are held after each phase of a project and involve stakeholders, team members, and project leaders, who assess the project’s achievements against its objectives and determine if it’s ready to move forward.

How close the average measured value is to the true or accepted reference value.

U

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 through its distribution and use. 

UDI requirements for device placed on US market are outlined in 21 CFR Subpart B- Labelling Requirements for Unique Device Identification and part § 830.20 of this chapter and for devices placed on EU market in Article 27 of the MDR and Article 24 of the IVDR. 

A Unique Device Identifier is a unique code assigned to a medical device consisting of two parts: a Device Identifier (DI) and a Production Identifier (PI). The DI identifies the specific version or model of the device. The PI identifies variable information like lot number, serial number or expiration date. UDI must be presented in both plain text and machine-readable formats (like barcode or QR code).

Manufacturers are responsible for assigning UDIs to their devices and submitting the relevant information to Global Device Identification Database (GUDID) when placing devices on US market.

Within the EU, the manufacturer shall assign to their devices together with UDI, also Basic-UDI-DI and register their devices in EUDAMED database. Basic-UDI-DI is the main access key for device-related information in EUDAMED database and is referenced in relevant documentation as EU Declaration of Conformity, technical documentation, Free Sales Certificates, summary of safety and (clinical) performance), etc.

Any healthcare professional or lay person who uses a device.

V

Confirmation, through the provision of objective evidence, that the requirements for a specific intended purpose or application have been fulfilled.

Verification is a test using objective evidence that specified characteristics (e.g., of products, components) have been fulfilled.

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