Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 1 - 3

Document information
Reference	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
Validity area	EU
Scope(s)	MD
Document name	Regulation (EU) 2017/745 - Medical Device Regulation
Version / Revision	20-Mar-2023
Status	Current
Document type	Legal act
Language(s)	EN
Description	REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 1 — Unit 1.2.3
Scope	MD
Document part	Article 2 Paragraph 1 - 3
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Medical device, Definition, Scope
Comment	Delimitations of clinical trials/studies

Content

Definitions

For the purposes of this Regulation, the following definitions apply:

(1) ‘medical device’ means 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.

(2) ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

(3) ‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;