MDD — Medical Devices Directive 93/42/EEC

The directive that governed most medical devices in the EU before the MDR, repealed by the MDR subject to transitional provisions. Devices certified under it are referred to in guidance as legacy devices.

Reference: MDR Article 122

MDSW — Medical device software

Software intended to be used, alone or in combination, for a medical purpose as set out in the definition of a medical device. Guidance distinguishes software that drives or influences a hardware device from software with an independent medical purpose, which is a device in its own right.

Reference: MDCG 2019-11

MEDDEV — MEDDEV guidance

The series of European consensus guidance documents produced under the directives, of which MEDDEV 2.7/1 revision 4 on clinical evaluation is the most used. Not legally binding and not written for the MDR, but still referenced in practice where MDCG guidance has not replaced it.

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)

MIR — Manufacturer incident report

The standard form used to report a serious incident to a competent authority under the vigilance system. The form and its coding are set out in Commission guidance rather than in the regulation itself, which specifies the reporting deadlines and the content required.

Reference: MDR Article 87; IVDR Article 82

NANDO — New Approach Notified and Designated Organisations

The Commission database listing notified bodies and the scope each is designated for. A designation takes effect the day after the notification is published there, so it is the authoritative source for checking whether a body may lawfully assess a given device type.

Reference: MDR Article 42; IVDR Article 38

Nanomaterial

A natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm; Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials.

Reference: MDR Article 2(18)

Negative predictive value

The ability of a device to separate true negative results from false negative results for a given attribute in a given population; 02017R0746 — EN — 10.01.2025 — 005.001 — 9.

Reference: IVDR Article 2(53)

Non-viable

Having no potential for metabolism or multiplication.

Reference: MDR Article 2(16)

Notified body

A conformity assessment body designated in accordance with this Regulation.

Reference: MDR Article 2(42); IVDR Article 2(34)

OBL — Own brand labelling

Placing another company’s device on the market under your own name or trade mark. Doing so makes you the manufacturer with all the accompanying obligations, unless there is an agreement under which the actual manufacturer is identified on the label and remains responsible.

Reference: MDR Article 16(1)(a); IVDR Article 16(1)(a)

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

Packaging levels

The various levels of device packaging that contain a defined quantity of devices, such as a carton or case.

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

Particle

For the purposes of the definition of nanomaterial in point (18), a minute piece of matter with defined physical boundaries.

Reference: MDR Article 2(19)

PEP — Performance evaluation plan

The plan setting out how scientific validity, analytical performance and clinical performance will be demonstrated for an IVD, including the intended purpose, the analyte or marker concerned, the characteristics to be evaluated and the acceptance criteria.

Reference: IVDR Annex XIII Part A point 1.1

PER — Performance evaluation report

The document in which the manufacturer assesses the scientific validity, analytical performance and clinical performance reports together, and states the clinical evidence supporting the intended purpose. It sits in the technical documentation alongside the performance evaluation plan.

Reference: IVDR Annex XIII Part A point 1.3.2

Performance study plan

A document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study.

Reference: IVDR Article 2(43)

Performance

The ability of a device to achieve its intended purpose as stated by the manufacturer.

Reference: MDR Article 2(22)

Performance of a device

The ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose.

Reference: IVDR Article 2(39)

Performance study

A study undertaken to establish or confirm the analytical or clinical performance of a device.

Reference: IVDR Article 2(42)