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

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

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

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

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)

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)