| The essential requirements are categorized
into |
| a) |
general requirements and |
| b) |
requirements regarding design and construction.
Below you will find an excerpt from the Medical Device
Directive. |
| |
General requirements: |
| 1. |
The devices must be designed and manufactured
in such a way that, when used under the conditions and
for the purposes intended, they will not compromise
the clinical condition or the safety of patients, or
the safety and health of users or, where applicable,
other persons, provided that any risks which may be
associated with their use constitute acceptable risks
when weighed against the benefits to the patient and
are compatible with a high level of protection of health
and safety. The solutions adopted by the manufacturer
for the design and construction of the devices must
conform to safety principles, taking account of the
generally acknowledged state of the art. |
| 2. |
In selecting the most appropriate solutions,
the manufacturer must apply the following principles
in the following order:
| · |
eliminate or reduce risks as far as possible
(inherently safe design and construction). |
| · |
where appropriate take adequate protection measures
including alarms if necessary, in relation to
risks that can not be eliminated. |
| · |
inform users of the residual risks due to any
shortcomings of the protection measures adopted. |
|
| 3. |
he devices must achieve the performances
intended by the manufacturer and be designed, manufactured
and packaged in such a way that they are suitable for
one or more of the functions referred to in Article
1 (2) (a), as specified by the manufacturer. |
| 4. |
The characteristics and performances referred
to in sections 1, 2 and 3 must not be adversely affected
to such a degree that the clinical condition and safety
of the patients and, where applicable, of other persons
are compromised during the lifetime of the device as
indicated by the manufacturer, when the device is subjected
to the stresses which can occur during normal conditions
of use. |
| 5. |
The devices must be designed, manufactured
and packed in such a way that their characteristics
and performances during their intended use will not
be adversely affected during transport and storage taking
account of the instructions and information provided
by the manufacturer. |
| 6. |
Any undesirable side effects must constitute
an acceptable risk when weighed against the performances
intended. |
| |
Requirements regarding design and construction |
| 7. |
Chemical, physical and biological properties |
| 8. |
Infection and microbial contamination |
| 9. |
Construction and environmental properties |
| 10. |
Devices with a measuring function |
| 11. |
Protection against radiation |
| 12. |
Requirements for medical devices connected
to or equipped with an energy source |
| 13. |
Information supplied by the manufacturer
and clinical data |
| |
|
