CA — Competent authority

The national authority designated by a Member State to apply the regulations: designating and monitoring notified bodies, running market surveillance and vigilance, and authorising clinical investigations or performance studies. Each Member State has its own, and they act independently of one another.

Reference: MDR Article 101; IVDR Article 96

CE marking — CE marking of conformity

A marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.

Reference: MDR Article 2(43); IVDR Article 2(35)

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

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 Validity is capped at five years, and certificates may be suspended, restricted or withdrawn where requirements are no longer met.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

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)

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)

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)

DoC — EU declaration of conformity

The manufacturer’s signed statement that a device meets the applicable requirements. It must be kept up to date, translated into the languages required by the Member States where the device is made available, and its minimum content is fixed by Annex IV.

Reference: MDR Article 19 and Annex IV; IVDR Article 17 and Annex IV

EURL — European Union reference laboratory

A laboratory designated under the IVDR to verify the performance of class D devices and check batches, and to provide scientific and technical assistance to the Commission and Member States. There is no direct MDR equivalent.

Reference: IVDR Article 100

Expert panel

A body of independent experts appointed to give scientific, technical and clinical opinions, including views on clinical evaluation under the consultation procedure and on common specifications.

Reference: MDR Article 106

Harmonised standard

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

Reference: MDR Article 2(70); IVDR Article 2(73)

IMDRF — International Medical Device Regulators Forum

A voluntary group of medical device regulators working towards converged regulatory approaches. Its documents carry no legal force in the EU, but several are referenced by MDCG guidance and are used to fill gaps where EU guidance is silent.

MDCG — Medical Device Coordination Group

The group of Member State experts that advises and assists the Commission, issues guidance on the application of both regulations, and contributes to notified body designation and scrutiny. Its guidance documents are not legally binding.

Reference: MDR Article 103

NANDO — New Approach Notified and Designated Organisations

The Commission database listing notified bodies and the scope each is designated for. A designation takes effect the day after the notification is published there, so it is the authoritative source for checking whether a body may lawfully assess a given device type.

Reference: MDR Article 42; IVDR Article 38

Notified body

A conformity assessment body designated in accordance with this Regulation.

Reference: MDR Article 2(42); IVDR Article 2(34)

WET — Well-established technology

A mature technology for which extensive, long-standing experience exists. The MDR does not define the term, but uses the concept in two places: exempting certain class IIb implantable devices from device-by-device technical documentation assessment, and exempting certain implantable and class III devices from the requirement to conduct clinical investigations.

Reference: MDR Article 52(4) and Article 61(6)(b)