RUO — Research use only

A product not intended for in vitro diagnostic examination and therefore outside the IVDR, unless the manufacturer specifically intends it for diagnostic use in view of its characteristics. Labelling a product research use only does not exempt it if its intended purpose is diagnostic.

Reference: IVDR Article 1(3)(a)

SaMD — Software as a medical device

The international term for software intended for a medical purpose that performs that purpose without being part of a hardware medical device. Broadly parallel to medical device software in EU guidance, but the definitions are not interchangeable and the EU term should be used in EU submissions.

Reference: IMDRF SaMD WG N41

Scientific validity report

The report demonstrating the association between an analyte and the clinical condition or physiological state it is intended to identify. It is one of the three inputs the manufacturer assesses when establishing clinical evidence for an IVD.

Reference: IVDR Annex XIII Part A points 1.2.1 and 1.3.1

Scientific validity of an analyte

The association of an analyte with a clinical condition or a physiological state.

Reference: IVDR Article 2(38)

Scientific validity

Used in the MDR in relation to how clinical data is planned, evaluated and concluded upon, without being defined there. Guidance treats it as covering adequacy of study design, control of bias, relevance of the research question, and the soundness of the methodology used to reach conclusions. Distinct from the IVDR term scientific validity of an analyte, which is defined and means something narrower.

Reference: MDCG 2020-6

Serious adverse event

Any adverse event that led to any of the following: (a) death, (b) serious deterioration in the health of the subject, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or prolongation of patient hospitalisation, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, (v) chronic disease, (c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect. Under the IVDR: any adverse event that led to any of the following: (a) a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring, (b) death, (c) serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or prolongation of patient hospitalisation, 02017R0746 — EN — 10.01.2025 — 005.001 — 10 (iv) medical or surgical intervention to prevent life- threatening illness or injury or permanent impairment to a body structure or a body function, (v) chronic disease, (d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect.

Reference: MDR Article 2(58); IVDR Article 2(61)

Serious public health threat

An event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.

Reference: MDR Article 2(66); IVDR Article 2(69)

Serious incident

Any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat. Under the IVDR: any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat; 02017R0746 — EN — 10.01.2025 — 005.001 — 11.

Reference: MDR Article 2(65); IVDR Article 2(68)

Shipping container

A container in relation to which traceability is controlled by a process specific to logistics systems.

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

Similar device

A device in the same generic device group as the subject device. Similarity supports contextual understanding, such as state of the art or safety and performance objectives, but it is not equivalence and does not permit another device’s clinical data to be used as if it were the subject device’s.

Reference: MDCG 2020-6

Single-use device

A device that is intended to be used on one individual during a single procedure. Under the IVDR: a device that is intended to be used during a single procedure; 02017R0746 — EN — 10.01.2025 — 005.001 — 5.

Reference: MDR Article 2(8); IVDR Article 2(9)

SOTA — State of the art

The developed stage of current technical capability and accepted clinical practice for a product, process or approach to patient management, based on consolidated findings of science, technology and experience. It is what is generally accepted as good practice now, not necessarily the most advanced technology available.

Reference: MDCG 2020-6; IMDRF GRRP WG N47

Specimen receptacle

A device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Reference: IVDR Article 2(3)

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. Under the IVDR: any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the performance study.

Reference: MDR Article 2(49); IVDR Article 2(57)

SRN — Single registration number

The identifier issued by a competent authority to a manufacturer, authorised representative or importer once its registration data has been verified. It is used when applying to a notified body and when accessing Eudamed.

Reference: MDR Article 31(2); IVDR Article 28(2)

SSCP — Summary of safety and clinical performance

A public-facing summary required for implantable and class III devices, other than custom-made or investigational devices. It is written for the intended user and, where relevant, the patient, is validated by the notified body during conformity assessment, and is published in Eudamed. The equivalent under the IVDR is the summary of safety and performance.

Reference: MDR Article 32

SSP — Summary of safety and performance

The IVDR counterpart to the SSCP, required for class C and class D devices other than devices for performance studies. It is validated by the notified body, uploaded to Eudamed, and its location must be stated on the label or in the instructions for use.

Reference: IVDR Article 29

Subject

An individual who participates in a clinical investigation. Under the IVDR: an individual who participates in a performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/or by a device used for control purposes.

Reference: MDR Article 2(50); IVDR Article 2(47)

System

A combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose.

Reference: MDR Article 2(11)

TD — Technical documentation

The manufacturer’s evidence file showing that a device meets the applicable requirements. Its contents are prescribed rather than optional: device description, design and manufacturing information, evidence against the general safety and performance requirements, risk management, verification and validation, and post-market surveillance documentation.

Reference: MDR Article 10(4) and Annexes II and III; IVDR Article 10(4) and Annexes II and III