The glossary provides definitions of the most important terms specified in the MDR. It is not necessary to look up terms in the legal text of the MDR – find the definitions and explanations you need here.
Depending on the type of medical device you provide to your patient, you take on different roles. As an orientation aid, we provide information about products here.
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).
[EU-MDR Article 2 (2)]
CE marking of conformity or CE marking means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.
[EU-MDR Article 2 (43)]
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, serial-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are serial-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. [see EU-MDR Article 2 (3)]
- Custom Made devices are a special type of medical device
- All requirements for medical devices therefore apply to custom-made devices as well
- Exemptions are clearly highlighted by „except for custom-made devices“
- Custom-made devices are only the parts that are individually manufactured for a specific patient with specific specifications
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 […].
[EU-MDR Aricle 2 (1)]
System means a combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose.
[EU-MDR Article 2 (11)]
Procedure pack means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.
[EU-MDR Article 2 (10)]
Find detailed explanations about the following roles here :
- Authorised representative
- Health institution
- Notified body
- Person responsible for regulatory compliance (PRRC)
Depending on the activity you undertake with the product for your patient, you will take on different roles. Here you find the three different possibilities that can be performed with a medical device.
Making available on the market means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.
[EU-MDR Article 2 (27)]
Placing on the market means the first making available of a device, other than an investigational device, on the Union market.
[EU-MDR Article 2 (28)]
Putting into service means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.
[EU-MDR Article 2 (29)]