Medical Device Investigations
Terms and Descriptions - 2.2
A–C
Term | Abbreviation | Description |
Adverse Device Effect | ADE | Adverse event related to the use of an investigational medical device. ISO 14155:2020 (3.1) |
Adverse Event | AE | 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 medical device. Regulation (EU) 2017/745, Article 2(57) |
Audit | --- | Systematic examination of activities and documents related to a clinical investigation performed by (an) independent person(s), to determine whether these activities were conducted, and the data recorded, analysed and accurately reported, according to the CIP, standard operating procedures, ISO 14155:2020 and applicable regulatory requirements. ISO 14155:2020 (3.3) |
Audit Trail | --- | Documentation that allows reconstruction of the course of events. ISO 14155:2020 (3.4) |
Benefit-Risk Determination | --- | 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. Regulation (EU) 2017/745, Article 2(24) |
Blinding / Masking | --- | Procedure in which one or more parties to the clinical investigation are kept unaware of the treatment assignment(s). ISO 14155:2020 (3.5) |
Case Report Form | CRF | Set of printed, optical or electronic documents for each subject on which information to be reported to the sponsor is recorded, as required by the CIP. ISO 14155:2020 (3.6) |
Certified Copy | --- | Copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature or by generation through a validated process) to have the same information including data that describe the context, content, and structure, as the original. ISO 14155:2020 (3.7) |
Conformité Européenne - marking | CE-marking | A marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in Regulation (EU) 2017/745 and other applicable Union harmonisation legislation providing for its affixing. Regulation (EU) 2017/745, Article 2(43) |
Clinical Benefit | --- | 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. Regulation (EU) 2017/745, Article 2(53) |
Clinical Data | --- | Information concerning safety or performance that is generated from the use of a device and is sourced from the following:
Regulation (EU) 2017/745, Article 2(48) |
Clinical Evaluation | --- | 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. Regulation (EU) 2017/745, Article 2(44) |
Clinical Evidence | --- | 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. Regulation (EU) 2017/745, Article 2(51) |
Clinical Investigation | --- | Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device. Regulation (EU) 2017/745, Article 2(45) |
Clinical Investigation Plan | CIP | A document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation. Regulation (EU) 2017/745, Article 2(47) |
Clinical Investigation Report | CIR | Document describing the design, execution, statistical analysis and results of a clinical investigation. ISO 14155:2020 (3.10) |
Clinical Performance | --- | 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. Regulation (EU) 2017/745, Article 2(52) |
Comparator | --- | Medical device, therapy (e.g. active treatment, normal clinical practice), placebo or no treatment, used in the control group in a clinical investigation. ISO 14155:2020 (3.12) |
Computer System | --- | Hardware and software (including associated documents, e.g. user manual) that creates, modifies, maintains, archives, retrieves, or transmits in digital form information related to the conduct of a clinical investigation. ISO 14155:2020 (3.13) |
Contract Research Organisation | CRO | Person or organisation contracted by the sponsor to perform one or more of the sponsor’s clinical investigation-related duties and functions. ISO 14155:2020 (3.14) |
Control Group | -- | Group of subjects that receives the comparator. ISO 14155:2020 (3.15) |
D–H
Term | Abbreviation | Description |
Data Monitoring Committee | DMC | Independent committee that can be established by the sponsor to assess, at intervals, the progress of the clinical investigation, the safety data or the critical clinical performance or effectiveness endpoints and to recommend to the sponsor whether to continue, suspend, modify, or to stop the clinical investigation. ISO 14155:2020 (3.17) |
Deviation | --- | Instance of failure to follow, intentionally or unintentionally, the requirements of the CIP. ISO 14155:2020 (3.18) |
Device Deficiency |
| 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. Regulation (EU) 2017/745, Article 2(59) |
Effectiveness | --- | Achievement of a clinically significant intended result in a defined portion of the target population when the investigational medical device is used within its intended used and according to its instructions for use, the investigator’s brochure and the CIP, as determined by documented scientific evidence. ISO 14155:2020 (3.20) |
Electronic Record | --- | Combination of text, graphics, data, audio, imaging, or other information in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. ISO 14155:2020 (3.21) |
Endpoint | --- | Principal indicator(s) used for providing the evidence for clinical performance, effectiveness or safety in a clinical investigation. ISO 14155:2020 (3.22) |
Endpoint | --- | Indicator(s) used for assessing the secondary objectives of a clinical investigation. ISO 14155:2020 (3.23) |
Essential Documents | --- | Documents which individually and collectively permit evaluation of the conduct of an investigation and the quality of the data produced. ICH E6 Guideline for Good Clinical Practice (1.23) The term is also mentioned, but not defined, in ISO 14155:2020. |
Ethics Committee
| EC | An independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purpose of this Regulation (MDR), taking into account the views of laypersons, in particular patients or patient’s organisations. Regulation (EU) 2017/745, Article 2(56) |
EUDAMED | --- | The European database on medical devices. Regulation (EU) 2017/745, Article 33(1) |
Good Clinical Practice | GCP | A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical investigations that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of subjects are protected. ICH E6 Guideline for Good Clinical Practice (1.24) |
Health Institution | --- | An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health. Regulation (EU) 2017/745, Article 2(36) |
Hypothesis | --- | Testable statement, derived from the objective of the clinical investigation to draw a conclusion about this objective, based on a pre-specified statistical test. ISO 14155:2020 (3.25) |
I–L
Term | Abbreviation | Description |
Implantable device | --- | 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. 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. Regulation (EU) 2017/745, Article 2(5) |
Independent | --- | Not involved in the development of the investigational device or the conduct of a clinical investigation, except for their specifically assigned responsibilities, in order to avoid bias or a conflict of interest. ISO 14155:2020 (3.26) |
Informed Consent | --- | 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. Regulation (EU) 2017/745, Article 2(55) |
Instructions for Use | --- | 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. Regulation (EU) 2017/745, Article 2(14) |
Intended Purpose | --- | 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. Regulation (EU) 2017/745, Article 2(12) |
Investigational Device | --- | A medical device that is assessed in a clinical investigation. Regulation (EU) 2017/745, Article 2(46) |
Investigation Site | --- | Institution or site where the clinical investigation is carried out. ISO 14155:2020 (3.28) |
Investigator | --- | An individual responsible for the conduct of a clinical investigation at a clinical investigation site. Regulation (EU) 2017/745, Article 2(54) |
Investigator’s Brochure | IB | A document containing the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. Regulation (EU) 2017/745, Annex XV, Chapter II (2) |
Label | --- | 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. EU MDR – Regulation (EU) 2017/745 |
Lay person | --- | An individual who does not have formal education in a relevant field of healthcare or medical discipline. Regulation (EU) 2017/745, Article 2(38) |
Legally Designated Representative | --- | Individual, judicial, or other body authorised under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical investigation. ISO 14155:2020 (3.32) |
M–P
Term | Abbreviation | Description |
Malfunction | --- | Failure of an investigational medical device to perform in accordance with its intended purpose when used in accordance with the instructions for use or CIP or IB. ISO 14155:2020 (3.33) |
Manufacturer | --- | 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. Regulation (EU) 2017/745, Article 2(30) |
Medical Device | MD | 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. The following products shall also be deemed to be medical devices:
Regulation (EU) 2017/745, Article 2(1) |
Medical Device Regulation | MDR | Referring to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. |
Monitoring | --- | Act of overseeing the progress of a clinical investigation to ensure that it is conducted, recorded, and reported in accordance with the CIP, written procedures, ISO 14155:2020, and the applicable regulatory requirements. ISO 14155:2020 (3.35) |
Monitoring Report | --- | A written report from the monitor to the sponsor after each site visit and/or other clinical investigation-related communication according to the sponsor’s SOPs. ICH E6 Guideline for Good Clinical Practice (1.39) The term is also mentioned, but not defined, in ISO 14155:2020. |
Multicentre Investigation | --- | Clinical investigation that is conducted according to a single CIP and takes place at two or more investigation sites. ISO 14155:2020 (3.36) |
Norwegian Medical Products Agency / Direktoratet for medisinske produkter | NOMA / DMP | The competent authority for medical devices in Norway, with administrative and advisory responsibilities related to legislation and supervisory authority over manufacturers, distributors and notified bodies. |
Objective | --- | Main purpose for conducting the clinical investigation. ISO 14155:2020 (3.37) |
Performance | --- | The ability of a device to achieve its intended purpose as stated by the manufacturer. Regulation (EU) 2017/745, Article 2(22) |
Point of Enrolment | --- | Time at which, following recruitment and before any clinical investigation-related procedures are undertaken, a subject signs and dates the informed consent form. ISO 14155:2020 (3.38) |
Post-Market Surveillance | PMS | 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. Regulation (EU) 2017/745, Article 2(60) |
Principal Investigator | PI | Qualified person responsible for conducting the clinical investigation at an investigation site. ISO 14155:2020 (3.39) Equivalent with the term investigator, defined in Regulation (EU) 2017/745. |
Q–S
Term | Abbreviation | Description |
Quality Control | QC | Operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the clinical investigation-related activities have been fulfilled. ISO 14155:2020 (3.41) |
Randomisation | --- | Process of assigning subjects to the investigational medical device or control groups using an established recognised statistical method using an element of chance to determine the unforeseeable assignment in order to reduce bias. ISO 14155:2020 (3.42) |
Recruitment | --- | Active efforts to identify subjects who can be suitable for enrolment into the clinical investigation. ISO 14155:2020 (3.43) |
Risk | --- | The combination of the probability of occurrence of harm and the severity of that harm. Regulation (EU) 2017/745, Article 2(23) |
Serious Adverse Device Effect | SADE | Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event. ISO 14155:2020 (3.44) |
Serious Adverse Event | SAE | Any adverse event that led to any of the following:
Regulation (EU) 2017/745, Article 2(58) |
Serious Health Threat | --- | Signal from any adverse event or device deficiency that indicates an imminent risk of death or a serious deterioration in the health in subjects, users or other persons, and that requires prompt remedial action for other subjects, users or other persons. ISO 14155:2020 (3.46) |
Source Data | --- | All information in original records, certified copies of original records of clinical findings, observations, or other activities in a clinical investigation, necessary for the reconstruction and evaluation of the clinical investigation. ISO 14155:2020 (3.47) |
Source Document | --- | Original or certified copy of printed, optical or electronic document containing source data. ISO 14155:2020 (3.48) |
Sponsor | --- | 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. Regulation (EU) 2017/745, Article 2(49) |
Standard Operating Procedure | SOP | Detailed, written instructions to achieve uniformity of the performance of a specific function. Describes responsibility, delegation and who does what, when and how. ICH E6 Guideline for Good Clinical Practice (1.55) |
Subject | --- | An individual who participates in a clinical investigation. Regulation (EU) 2017/745, Article 2(50) |
Term | Abbreviation | Description |
Unanticipated Serious Adverse Device Effect | USADE | Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current risk assessment. ISO 14155:2020 (3.51) |
Unique Device Identifier | UDI | A series of numeric or alphanumeric characters that is created through internally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market. Regulation (EU) 2017/745, Article 2(15) |
Use Error | --- | User action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user. ISO 14155:2020 (3.52) |
User | --- | Any healthcare professional or lay person who uses a device. Regulation (EU) 2017/745, Article 2(37) |
Validation | --- | Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. ISO 14155:2020 (3.53) |
Verification | --- | Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. ISO 14155:2020 (3.54) |
Vulnerable Subject | --- | Individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response. ISO 14155:2020 (3.55) |
