IVD Essential Principles Checklist

ESSENTIAL PRINCIPLES CHECKLIST
Identity of the IVD:
Method Used
Applicable to to Method Reference to Supporting Controlled
Essential Principle
the device? Demonstrate Reference Documents
Conformity
General Requirements
1.1 Medical devices should be designed and manufactured in such a way that, when used
under the conditions and for the purposes intended and, where applicable, by virtue of the
technical knowledge, experience, education or training of intended users, 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.
1.2 The solutions adopted by the manufacturer for the design and manufacture of the
devices should conform to safety principles, taking account of the generally acknowledged
state of the art. When risk reduction is required, the manufacturer should control the
risk(s) so that the residual risk(s) associated with each hazard is judged acceptable. The
manufacturer should apply the following principles in the priority order listed:
 identify known or foreseeable hazards and estimate the associated risks arising
from the intended use and foreseeable misuse
 eliminate risks as far as reasonably practicable through inherently safe design and
manufacture
 reduce as far as is reasonably practicable the remaining risks by taking adequate
protection measures, including alarms
 inform users of any residual risks.
1.3 Medical devices should achieve the performance intended by the manufacturer and be
designed and manufactured in such a way that, during normal conditions of use, they are
suitable for their intended purpose.
Method Used
Applicable to to Method Reference to Supporting Controlled
Essential Principle
the device? Demonstrate Reference Documents
Conformity
1.4 The characteristics and performances referred to in Clauses 1.1, 1.2 and 1.3 should not
be adversely affected to such a degree that the health or safety of the patient or the user
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 and has been properly maintained in accordance
with the manufacturer’s instructions.
1.5 The devices should be designed, manufactured and packed in such a way that their
characteristics and performances during their intended use will not be adversely affected
under transport and storage conditions (for example, fluctuations of temperature and
humidity) taking account of the instructions and information provided by the manufacturer.
1.6 All known and foreseeable risks, and any undesirable effects, should be minimised and
be acceptable when weighed against the benefits of the intended performance of medical
devices during normal conditions of use.
Design and Manufacturing Requirements
2.1 Chemical, physical and biological properties.
2.2 The devices should be designed and manufactured in such a way as to ensure the
characteristics and performance referred to in Clauses 1.1 to 1.6 of the General
Requirements. Particular attention should be paid to:
 the choice of materials used, particularly as regards toxicity and, where appropriate,
flammability
 the compatibility between the materials used and biological tissues, cells, body fluids,
and specimens, taking account of the intended purpose of the device
 the choice of materials used should reflect, where appropriate, matters such as
hardness, wear and fatigue strength.
The devices should be designed, manufactured and packed in such a way as to minimize
the risk posed by contaminants and residues to the persons involved in the transport,
storage and use of the devices and to patients, taking account of the intended purpose of
the product. Particular attention should be paid to tissues exposed and to the duration and
frequency of exposure.
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IVD Essential Principles Checklist

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IVD Essential Principles Checklist

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ESSENTIAL PRINCIPLES CHECKLIST

Identity of the IVD:

Design and Manufacturing Requirements

2.1 Chemical, physical and biological properties.

------------------------------- etc. --------------------------------------------

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