Is your product a Medical Device (MD) ?
1- Yes;
i.e., a kind of instrument, apparatus, appliance, material or other article, 2- No;
whether used alone or in combination, including the software necessary for
3- Do not
the proper application, intended by the manufacturer to be used for human
know
beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of a disease, If MD, which class?
an injury or a handicap.
investigation, replacement or modification of the anatomy or of a Class I ?
physiological process. Class IIa ?
control of conception
and which does not achieve its principal intended action in or on the human Class IIb ?
body by pharmacological, immunological or metabolic means, but which Class III ?
may be assisted by such means ?*
Do not know
Is your product In-vitro Diagnostic Medical Device (IVD)?
1- Yes;
which is a reagent, reagent product, calibrator, control material, kit, 2- No;
instrument, apparatus, equipment, or system, whether used alone or in
3- Do not
combination, intended by the manufacturer to be used in vitro for the
know
examination of specimens, including blood and tissue donations, derived
from the human body, solely or principally for the purpose of providing If IVD, which
information: category?
- concerning a physiological or pathological state, or
- concerning a congenital abnormality, or Other ?
- to determine the safety and compatibility with potential recipients, or Self-Testing ?
- to monitor therapeutic measures ?*
List B ?
List A ?
Do not know
Is your product an Active Implantable Medical Device (AIMD)?
1- Yes;
i.e., a medical device relying for its functioning on a source of electrical 2- No;
energy or any source of power other than that directly generated by the
3- Do not
human body or gravity and the device is intended to be totally or partially
know
introduced, surgically or medically, into the human body or by medical
intervention into a natural orifice, and which is intended to remain after
the procedure ?*
Is your product a Personal Protective Equipment (PPE) under -
1- Yes;
Directive 89/686/EEC?
2- No;
i.e., a device or appliance designed to be worn or held by an
3- Do not
individual for protection against one or more health and safety hazards ?
know
*
Is your product a LVD?
1- Yes;
i.e. the kind of equipment designed for use with a voltage rating of
between 50 and 1000 V for alternating current (A.C.) and between 75 and 2- No;
1500 V for direct current (D.C.) ?* 3- Do not
know
Is your product a machinery?* 1- Yes;
The "machinery" means:
an assembly of linked parts or components, at least one of which moves, with the 2- No;
appropriate actuators, control and power circuits, etc., joined together for a specific
application, in particular for the processing, treatment, moving or packaging of a material, 3- Do not
an assembly of machines which, in order to achieve the same end, are arranged and know
controlled so that they function as an integral whole,
interchangeable equipment modifying the function of a machine, which is placed on the
market for the purpose of being assembled with a machine or a series of different machines
or with a tractor by the operator himself in so far as this equipment is not a spare part or a
tool.
Is your product a Radio Equipment or Telecommunications Terminal
1- Yes;
Equipment ?*
A "radio equipment" means a product, or relevant component thereof, 2- No;
capable of communication by means of the emission and/or reception of 3- Do not
radio waves utilising the spectrum allocated to terrestrial/space radio- know
communication.
A "telecommunications terminal equipment" means a product enabling
communication or a relevant component thereof which is intended to be
connected directly or indirectly by any means whatsoever to interfaces of
public telecommunications networks (that is to say, telecommunications
networks used wholly or partly for the provision of publicly available
telecommunications services).
Is your product designed or intended, whether or not exclusively, for use
1- Yes;
in play by children under 14 years of age. ?*
2- No;
3- Do not
know
