Represents the positive impact of a device on human health, expressed through meaningful and measurable outcomes. It may relate to patient-relevant outcomes, improvements in patient management, or benefits for public health — always ensuring a favourable contribution to an individual’s health.

A type of medical device that;
– depends on a source of energy (can be a stored energy), other than generated by human or gravity,
– and acts by changing its density or converting that energy, (mechanical, electrical, thermal, light, sound, nuclear etc.)
– achieves its intended purpose by transmitting that energy to the patient or using that energy to transmit substances to the patient.

A risk-based categorization for medical devices based on the potential risks they pose and the vulnerability of the applied human body. [Class I (Is,Im,Ir), IIa, IIb, III]

Guidelines help determine the ultimate regulatory framework for conflicting products at the intersection of the MDR, IVDR, Cosmetics, Biocides, and the Medicinal Products Directive.

A group of devices that serve both medical and non-medical purposes (e.g., cosmetic), regulated under the MDR as both medical devices and Annex XVI products.

A group of products solely intended for non-medical purposes (e.g., cosmetic)—not medical ones—yet still regulated under the EU Medical Device Regulation (MDR).

PMCF stands for Post-Market Clinical Follow-Up. It involves targeted activities conducted to monitor the clinical safety and performance of a medical device after it becomes available on the market