Medical device

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: — devices for the control or support of conception; — products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point. (1) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24). Under the IVDR: ‘medical device’ as defined in point (1) of Article 2 of Regulation (EU) 2017/745.

Reference: MDR Article 2(1); IVDR Article 2(1)

Orphan device

A device specifically intended to benefit patients with a disease or condition presenting in no more than 12,000 individuals in the EU per year, where there is an insufficiency of available alternatives or where clinical data cannot reasonably be generated in the usual way. A guidance concept affecting the clinical evidence expected.

Reference: MDCG 2024-10

Procedure pack

A combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.

Reference: MDR Article 2(10)

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

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)

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)

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)