CDP — Clinical development plan

The part of the clinical evaluation plan setting out the progression of clinical investigations, from exploratory work such as first-in-human or feasibility studies through to confirmatory investigations, together with the milestones and acceptance criteria along the way.

Reference: MDR Annex XIV Part A point 1(a)

CEP — Clinical evaluation plan

The plan that sets out how the clinical evaluation will be conducted before it starts: the intended purpose and claims, the general safety and performance requirements needing clinical evidence, the clinical benefits and outcome parameters, and the methods for appraising the data.

Reference: MDR Annex XIV Part A point 1(a)

CER — Clinical evaluation report

The document recording the results of the clinical evaluation and the clinical evidence it rests on. It supports the conformity assessment of the device, forms part of the technical documentation, and must be updated throughout the device lifetime with data from post-market clinical follow-up.

Reference: MDR Article 61(12) and Annex XIV Part A point 4

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. Under the IVDR: 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; 02017R0746 — EN — 10.01.2025 — 005.001 — 8.

Reference: MDR Article 2(52); IVDR Article 2(41)

Clinical data

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.

Reference: MDR Article 2(48)

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. Under the IVDR: the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health.

Reference: MDR Article 2(53); IVDR Article 2(37)

Clinical investigation

Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.

Reference: MDR Article 2(45)

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. Under the IVDR: clinical data and performance 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.

Reference: MDR Article 2(51); IVDR Article 2(36)

Clinical investigation plan

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

Reference: MDR Article 2(47)

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.

Reference: MDR Article 2(44)

Equivalence

The basis on which clinical data relating to another device may be used to support a clinical evaluation, provided technical, biological and clinical characteristics are sufficiently similar that no clinically significant difference in safety or performance results. The manufacturer must also demonstrate sufficient access to the other device’s data.

Reference: MDR Annex XIV Part A point 3; MDCG 2020-5

Ethics committee

An independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations.

Reference: MDR Article 2(56); IVDR Article 2(59)

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. Under the IVDR: a subject's free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all aspects of the performance study 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 performance study.

Reference: MDR Article 2(55); IVDR Article 2(58)

Interventional clinical performance study

A clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment.

Reference: IVDR Article 2(46)

Investigator

An individual responsible for the conduct of a clinical investigation at a clinical investigation site. Under the IVDR: an individual responsible for the conduct of a performance study at a performance study site.

Reference: MDR Article 2(54); IVDR Article 2(48)

MCID — Minimal clinically important difference

The smallest change in an outcome measure that a patient would perceive as meaningful. Used when setting clinical benefit and outcome parameters, so that statistically significant results are not mistaken for clinically relevant ones. A clinical research concept, not a regulatory definition.

MEDDEV — MEDDEV guidance

The series of European consensus guidance documents produced under the directives, of which MEDDEV 2.7/1 revision 4 on clinical evaluation is the most used. Not legally binding and not written for the MDR, but still referenced in practice where MDCG guidance has not replaced it.

PEP — Performance evaluation plan

The plan setting out how scientific validity, analytical performance and clinical performance will be demonstrated for an IVD, including the intended purpose, the analyte or marker concerned, the characteristics to be evaluated and the acceptance criteria.

Reference: IVDR Annex XIII Part A point 1.1

PER — Performance evaluation report

The document in which the manufacturer assesses the scientific validity, analytical performance and clinical performance reports together, and states the clinical evidence supporting the intended purpose. It sits in the technical documentation alongside the performance evaluation plan.

Reference: IVDR Annex XIII Part A point 1.3.2

Performance study plan

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

Reference: IVDR Article 2(43)