Glossary of terms

A premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

The substance or chemical constituent being identified and measured in an analytical procedure or diagnostic test.

The ability of a material or device to perform with an appropriate host response when applied as intended, without causing adverse effects.

Contract Development and Manufacturing Organisation. A company that provides development and manufacturing services to the pharmaceutical, biotechnology and diagnostics industries on a contract basis.

A certification mark indicating conformity with health, safety and environmental protection standards for products sold within the European Economic Area.

The ability of a diagnostic device to yield results correlating with particular clinical conditions or physiological states in the target population.

Gold nanoparticles used as detection labels in lateral flow immunoassays, producing the characteristic red or pink test line visible to the naked eye.

An in vitro diagnostic device that provides information essential for the safe and effective use of a corresponding therapeutic product.

Contract Research Organisation. A company providing research services, including clinical trial management and performance evaluation, on behalf of pharmaceutical and diagnostics companies.

A systematic approach to the design and development of medical devices, required under FDA 21 CFR 820 and ISO 13485.

European Union Medical Devices Regulation (EU) 2017/745, governing the safety and performance requirements for medical devices placed on the EU market.

Chemical compounds that can be extracted from or leach out of materials, packaging or devices under specified conditions, relevant to safety assessment.

The United States Food and Drug Administration, responsible for regulating food, drugs, medical devices and diagnostics.

Good Manufacturing Practice. A system ensuring products are consistently produced and controlled according to quality standards.

A biochemical test that measures the presence or concentration of a substance using an antibody-antigen reaction.

An international standard specifying requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services.

The international standard for the application of risk management to medical devices, covering hazard identification, risk estimation, evaluation and control.

The international standard for testing and calibration laboratories. Accreditation to ISO/IEC 17025 demonstrates technical competence, validated methods and robust quality management systems, providing confidence in the accuracy and reliability of laboratory data.

In vitro diagnostic. A test performed on samples such as blood, urine or tissue taken from the human body, used for diagnosis, monitoring or screening.

In Vitro Diagnostic Regulation (EU) 2017/746, the European regulation governing in vitro diagnostic medical devices.

A paper-based diagnostic device designed to detect the presence of a target substance in a sample, using capillary flow along a membrane strip.

Medicines and Healthcare products Regulatory Agency. The UK government agency responsible for regulating medicines, medical devices and blood components for transfusion.

Technology dealing with the precise control and manipulation of fluids at the sub-millimetre scale, used in advanced diagnostic devices.

A diagnostic test capable of simultaneously detecting and measuring multiple analytes or biomarkers from a single sample.

A porous membrane material used as the detection surface in lateral flow tests, providing protein-binding properties for capturing target molecules.

An organisation designated by an EU member state to assess the conformity of certain products, including medical devices and IVDs, before they are placed on the market.

The systematic assessment of an IVD device’s analytical and clinical performance to demonstrate it meets its intended purpose.

Premarket Approval. The FDA regulatory pathway for Class III medical devices, requiring clinical evidence of safety and effectiveness.

Diagnostic testing performed near or at the site of patient care, rather than in a centralised laboratory.

The systematic monitoring of the safety and performance of medical devices and IVDs after they have been placed on the market.

Quality Management System. A formalised system documenting processes, procedures and responsibilities for achieving quality policies and objectives.

The ability of a diagnostic test to correctly identify individuals with the condition (true positive rate).

The ability of a diagnostic test to correctly identify individuals without the condition (true negative rate).