CEAR — Clinical evaluation assessment report

The notified body’s written assessment of a manufacturer’s clinical evaluation, produced during conformity assessment. Deficiencies raised in it are a common cause of delay to certification.

Reference: MDR Article 61(7)

CECP — Clinical evaluation consultation procedure

The additional scrutiny applied to certain class III implantable devices and class IIb active devices intended to administer or remove a medicinal product, in which an expert panel may review the notified body’s assessment of the clinical evaluation before certification.

Reference: MDR Article 54 and Annex IX Section 5.1

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

Certificate of conformity — Certificates of conformity

The certificates issued by a notified body when a device or quality management system passes conformity assessment. Validity is capped at five years, and certificates may be suspended, restricted or withdrawn where requirements are no longer met.

Reference: MDR Article 56 and Annex XII

Certificate of free sale

A certificate issued by a Member State, at the manufacturer’s request, confirming that a device may lawfully be sold in the Union. Typically requested to support registration in export markets.

Reference: MDR Article 60

Classification — Classification of devices

The rules that assign a device to a risk class, which then determines the conformity assessment route and the level of notified body involvement. Under the MDR devices fall into classes I, IIa, IIb and III according to the rules in Annex VIII. Under the IVDR devices fall into classes A, B, C and D under a different Annex VIII rule set.

Reference: MDR Article 51 and Annex VIII; IVDR Article 47 and Annex VIII

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)

Compatibility

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. Under the IVDR: 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; 02017R0746 — EN — 10.01.2025 — 005.001 — 6.

Reference: MDR Article 2(25); IVDR Article 2(18)

Companion diagnostic

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 as a result of treatment with the corresponding medicinal product.

Reference: IVDR Article 2(7)

Configuration

A combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to meet specific needs. Configurations include inter alia: — gantries, tubes, tables, consoles and other items of equipment that can be configured/combined to deliver an intended function in computed tomography. — ventilators, breathing circuits, vaporizers combined to deliver an intended function in anaesthesia.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Configurable device

A device that consists of several components which can be assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves. Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia systems, physiological Monitoring systems, radiology information systems (RIS).

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Conformity assessment procedure

The route a manufacturer takes to demonstrate compliance, chosen according to the device’s classification. Routes combine quality management system assessment, technical documentation assessment and, for some devices, type-examination or product verification.

Reference: MDR Article 52 and Annexes IX to XI; IVDR Article 48 and Annexes IX to XI

Conformity assessment

The process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled.

Reference: MDR Article 2(40); IVDR Article 2(32)