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 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

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 Validity is capped at five years, and certificates may be suspended, restricted or withdrawn where requirements are no longer met.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

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 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 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)

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 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)

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)

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

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

Conformity assessment body

A body that performs third-party conformity assessment activities including calibration, testing, certification and inspection.

Reference: MDR Article 2(41); IVDR Article 2(33)

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)

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

Corrective action

Action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.

Reference: MDR Article 2(67); IVDR Article 2(70)

CS — Common specifications

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. Under the IVDR: 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. Section 2 Regulatory status of products and counselling.

Reference: MDR Article 2(71); IVDR Article 2(74)

Custom-made device

Any device specifically made in accordance with a written prescription of any person authorised 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 authorised person shall not be considered to be custom-made devices.

Reference: MDR Article 2(3)