Medical Devices Glossary

Medical Device

„Medical Device“ means any Instrument, Apparatus, Equipment, Software, Implant, Reagent, Material or other Item, whether used alone or in combination, intended by the manufacturer to serve one or more of the following specific Medical Purposes:

Diagnosis, Prevention, Monitoring, Prediction, Prognosis, Treatment or alleviation of disease;
Diagnosis, Monitoring, Treatment, Palliation or Compensation for an Injury or a Disability,
Examination, Replacement or Modification of the Anatomy or of a Physiological or Pathological Process or State,
Obtaining of Information by means of In Vitro Examination of Specimens Derived from the Human Body, including from 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, although its action may be assisted by such means.

The following products are also considered to be Medical Devices:

products to prevent or promote pregnancy,
products specifically to clean, disinfect or sterilize devices referred to in Article 1(4) and products referred to in the first paragraph of this indent.

Customized Products

A customized Medical Device is a Medical Device that is specifically produced according to a written prescription for a named patient and is intended for the exclusive use of that patient. A serially manufactured Medical Device that needs to be adapted to meet the specific requirements of a physician, dentist or other professional user is not considered a customized Medical Device.

Components

Components for Medical Devices are Objects, Materials, Preparations made of Materials as well as Software that are not Medical Devices themselves, but are intended by the manufacturer to be used with a Medical Device so that it can be used in accordance with the intended purpose of the Medical Device.

Market Launch

Market Launch means any supply of Medical Devices to others, whether in return for payment or free of charge. (…) Market Launch according to this law does not include:

the supply of Medical Devices for the purpose of Clinical Investigation,
the supply of in Vitro Diagnostic Medical Devices for Performance Evaluation,
the re-supply of a Medical Device after it has been put into service, unless it has been reprocessed as new or substantially modified.

Supply to another person is not deemed to have occurred if Medical Devices are processed for and returned to another person.

Intended Purpose

The Intended Purpose is the use for which the Medical Device is intended, as specified by the Labelling, Instructions for Use or Advertising Materials (…).

Notified Bodies

A Notified Body is a Body designated by a State Party to the Agreement on the European Economic Area to carry out tests and issue certificates in connection with conformity assessment procedures (…), which is notified to the Commission of the EC (…).

Authorized Representative

The Authorized Representative is the natural or legal person established in the European Economic Area who has been explicitly designated by the manufacturer to act on his behalf with regard to his obligations under this law and to be available to the authorities and competent bodies.

CE Labeling

Proven conformity of a product with the essential safety and performance requirements (in accordance with the legal framework). The manufacturer indicates this by affixing the CE Labeling on the product (and packaging). The identification of the Notified Body as a 4-digit code next to or below the CE Label (e.g. 0123 for TÜV Product Service or 0297 for DQS Med and many more… see NANDO) may be necessary depending on the Risk Class.

Many more definitions can be found in the very comprehensive Austrian Medical Device Glossary.