|
 ANNEX I
ESSENTIAL REQUIREMENTS
I. 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. |
| 2. |
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. In selecting the most appropriate solutions, the manufacturer must
apply the following principles in the following order: |
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eliminate or reduce risks as far as possible (inherently safe design and
construction); |
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where appropriate take adequate protection measures including alarms if nesessary, in
relation to risks that cannot be eliminated; |
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inform users of the residual risks due to any shortcomings of the protection measures
adopted. |
| 3. |
The 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 conditions 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-effect must constitute an acceptable risk when weighed against
the performances intended. |
II. REQUIREMENTS REGARDING DESIGN AND
CONSTRUCTION
| 7. |
Chemical, physical and biological properties
|
| 7.1. |
The devices must be designed and manufactured in such a way as to guarantee the
characteristics and performances referred to in Section I on the 'General requirements'.
Particular attention must 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 and body
fluids, taking account of the intended purpose of the device. |
| 7.2. |
The devices must 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 the patients, taking account of the intended purpose of the
product. Particular attention must be paid to the tissues exposed and to the duration and
frequency of exposure. |
| 7.3. |
The devices must be designed and manufactured in such a way that they can be used
safely with the materials, substances and gases with which they enter into contact during
their normal use or during routine procedures; if the devices are intended to administer
medicinal products they must be designed and manufactured in such a way as to be
compatible with the medicinal products concerned according to the provisions and
restrictions governing these products and that their performance is maintained in
accordance with the intended use. |
| 7.4. |
Where a device incorporates, as an integral part, a substance which, if used
separately, may be considered to be a medicinal product as defined in Article 1 of
Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that
of the device, the safety, quality and usefulness of the substance must be verified,
taking account of the intended purpose of the device, by analogy with the appropriate
methods specified in Directive 75/318/EEC. |
| 7.5. |
The devices must be designed and manufactured in such a way as to reduce to a minimum
the risks posed by substances leaking from the device. |
| 7.6. |
Devices must be designed and manufactured in such a way as to reduce, as much as
possible, risks posed by the unintentional ingress of substances into the device taking
into account the device and the nature of the environment in which it is intended to be
used. |
| 8. |
Infection and microbial contamination |
| 8.1. |
The devices and manufacturing processes must be designed in such a way as to eliminate
or reduce as far as possible the risk of infection to the patient, user and third parties.
The design must allow easy handling and, where necessary, minimize contamination of the
device by the patient or vice versa during use. |
| 8.2. |
Tissues of animal origin must originate from animals that have been subjected to
veterinary controls and surveillance adapted to the intended use of the tissues. Notified
bodies shall retain information on the geographical origin of the animals.
Processing, preservation, testing and handling of tissues, cells and substances of
animal origin must be carried out so as to provide optimal security. In particular safety
with regard to viruses and other transferable agents must be addressed by implementation
of validated methods of elimination or viral inactivation in the course of the
manufacturing process. |
| 8.3. |
Devices delivered in a sterile state must be designed, manufactured and packed in a
non-reusable pack and/or according to appropriate procedures to ensure that they are
sterile when placed on the market and remain sterile, under the storage and transport
conditions laid down, until the protective packaging is damaged or opened. |
| 8.4. |
Devices delivered in a sterile state must have been manufactured and sterilized by an
appropriate, validated method. |
| 8.5. |
Devices intended to be sterilized must be manufactured in appropriately controlled (e.
g. environmental) conditions. |
| 8.6. |
Packaging systems for non-sterile devices must keep the product without deterioration
at the level of cleanliness stipulated and, if the devices are to be sterilized prior to
use, minimize the risk of microbial contamination; the packaging system must be suitable
taking account of the method of sterilization indicated by the manufacturer. |
| 8.7. |
The packaging and/or label of the device must distinguish between identical or similar
products sold in both sterile and non-sterile condition. |
| 9. |
Construction and environmental properties |
| 9.1. |
If the device is intended for use in combination with other devices or equipment, the
whole combination, including the connection system must be safe and must not impair the
specified performances of the devices. Any restrictions on use must be indicated on the
label or in the instructions for use. |
| 9.2. |
Devices must be designed and manufactured in such a way as to remove or minimize as
far as is possible: |
| - |
the risk of injury, in connection with their physical features, including the
volume/pressure ratio, dimensional and where appropriate ergonomic features, |
| - |
risks connected with reasonably foreseeable environmental conditions, such as magnetic
fields, external electrical influences, electrostatic discharge, pressure, temperature or
variations in pressure and acceleration, |
| - |
the risks of reciprocal interference with other devices normally used in the
investigations or for the treatment given, |
| - |
risks arising where maintenance or calibration are not possible (as with implants),
from ageing of materials used or loss of accuracy of any measuring or control mechanism. |
| 9.3. |
Devices must be designed and manufactured in such a way as to minimize the risks of
fire or explosion during normal use and in single fault condition. Particular attention
must be paid to devices whose intended use includes exposure to flammable substances or to
substances which could cause combustion. |
| 10. |
Devices with a measuring function |
| 10.1. |
Devices with a measuring function must be designed and manufactured in such a way as
to provide sufficient accuracy and stability within appropriate limits of accuracy and
taking account of the intended purpose of the device. The limits of accuracy must be
indicated by the manufacturer. |
| 10.2. |
The measurement, monitoring and display scale must be designed in line with ergonomic
principles, taking account of the intended purpose of the device. |
| 10.3. |
The measurements made by devices with a measuring function must be expressed in legal
units conforming to the provisions of Council Directive 80/181/EEC (20). |
(20) OJ No L 39, 15.2.1980, p. 40.
Directive as last amended by Directive 89/617/EEC (OJ No L 357, 7.12.1989, p. 28).
| 11. |
Protection against radiation |
| 11.1. |
General |
| 11.1.1. |
Devices shall be designed and manufactured in such a way that exposure of patients,
users and other persons to radiation shall be reduced as far as possible compatible with
the intended purpose, whilst not restricting the application of appropriate specified
levels for therapeutic and diagnostic purposes. |
| 11.2. |
Intended radiation |
| 11.2.1. |
Where devices are designed to emit hazardous levels of radiation necessary for a
specific medical purpose the benefit of which is considered to outweigh the risks inherent
in the emission, it must be possible for the user to control the emissions. Such devices
shall be designed and manufactured to ensure reproducibility and tolerance of relevant
variable parameters. |
| 11.2.2. |
Where devices are intended to emit potentially hazardous, visible and/or invisible
radiation, they must be fitted, where practicable, with visual displays and/or audible
warnings of such emissions. |
| 11.3. |
Unintended radiation |
| 11.3.1. |
Devices shall be designed and manufactured in such a way that exposure of patients,
users and orher persons to the emission of unintended, stray or scattered radiation is
redused as far as possible. |
| 11.4. |
Instructions |
| 11.4.1. |
The operating instructions for devices emitting radiation must give detailed
information as to the nature of the emitted radiation, means of protecting the patient and
the user and on ways of avoiding misuse and of eliminating the risks inherent in
installation. |
| 11.5. |
Ionizing radiation |
| 11.5.1. |
Devices intended to emit ionizing radiation must be designed and manufactured in such
a way as to ensure that, where practicable, the quantity, geometry and quality of
radiation emitted can be varied and controlled taking into account the intended use. |
| 11.5.2. |
Devices emitting ionizing radiation intended for diagnostic radiology shall be
designed and manufactured in such a way as to achieve appropriate image and/or output
quality for the intended medical purpose whilst minimizing radiation exposure of the
patient and user. |
| 11.5.3. |
Devices emitting ionizing radiation intended for therapeutic radiology shall be
designed and manufactured in such a way as to enable reliable monitoring and control of
the delivered dose, the beam type and energy and where appropriate the quality of
radiation. |
| 12. |
Requirements for medical devices connected to or
equipped with an energy source |
| 12.1. |
Devices incorporating electronic programmable systems must be designed to ensure the
repeatability, reliability and performance of these systems according to the intended use.
In the event of a single fault condition (in the system) appropriate means should be
adopted to eliminate or reduce as far as possible consequent risks |
| 12.2. |
Devices where the safety of the patients depends on an internal power supply must be
equipped with a means of determining the state of the power supply. |
| 12.3. |
Devices where the safety of the patients depends on an external power supply must
include an alarm system to signal any power failure. |
| 12.4. |
Devices intended to monitor one or more clinical parameters of a patient must be
equipped with appropriate alarm systems to alert the user of situations which could lead
to death or severe deterioration of the patient's state of health. |
| 12.5. |
Devices must be designed and manufactured in such a way as to minimize the risks of
creating electromagnetic fields which could impair the operation of other devices or
equipment in the usual environment. |
| 12.6. |
Protection against electrical risks |
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Devices must be designed and manufactured in such a way as to avoid, as far as
possible, the risk of accidental electric shocks during normal use and in single fault
condition, provided the devices are installed correctly. |
| 12.7. |
Protection against mechanical and thermal risks |
| 12.7.1. |
Devices must be designed and manufactured in such a way as to protect the patient and
user against mechanical risks connected with, for example, resistance, stability and
moving parts. |
| 12.7.2. |
Devices must be designed and manufactured in such a way as to reduce to the lowest
possible level the risks arising from vibration generated by the devices, taking account
of technical progress and of the means available for limiting vibrations, particularly at
source, unless the vibrations are part of the specified performance. |
| 12.7.3. |
Devices must be designed and manufactured in such a way as to reduce to the lowest
possible level the risks arising from the noise emitted, taking account of technical
progress and of the means available to reduce noise, particularly at source, unless the
noise emitted is part of the specified performance. |
| 12.7.4. |
Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy
supplies which the user has to handle must be designed and constructed in such a way as to
minimize all possible risks. |
| 12.7.5. |
Accessible parts of the devices (excluding the parts or areas intended to supply heat
or reach given temperatures) and their surroundings must not attain potentially dangerous
temperatures under normal use. |
| 12.8. |
Protection against the risks posed to the patient by energy supplies or
substances |
| 12.8.1. |
Devices for supplying the patient with energy or substances must be designed and
constructed in such a way that the flow-rate can be set and maintained accurately enough
to guarantee the safety of the patient and of the user. |
| 12.8.2. |
Devices must be fitted with the means of preventing and/or indicating any inadequacies
in the flow-rate which could pose a danger. Devices must incorporate suitable means to
prevent, as far as possible, the accidental release of dangerous levels of energy from an
energy and/or substance source. |
| 12.9. |
The function of the controls and indicators must be clearly specified on the devices. Where
a device bears instructions required for its operation or indicates operating or
adjustment parameters by means of a visual system, such information must be understandable
to the user and, as appropriate, the patient. |
| 13. |
Information supplied by the manufacturer |
| 13.1. |
Each device must be accompanied by the information needed to use it safely and to
identify the manufacturer, taking account of the training and knowledge of the potential
users. This information comprises the details on the label and the data in the
instructions for use.
As far as practicable and appropriate, the information needed to use the device safely
must be set out on the device itself and/or on the packaging for each unit or, where
appropriate, on the sales packaging. If individual packaging of each unit is not
practicable, the information must be set out in the leaflet supplied with one or more
devices.
Instructions for use must be included in the packaging for every device. By way of
exception, no such instructions for use are needed for devices in Class I or IIa if
they can be used safely without any such instructions. |
| 13.2. |
Where appropriate, this information should take the form of symbols. Any symbol or
identification colour used must conform to the harmonized standards. In areas for which no
standards exist, the symbols and colours must be described in the documentation supplied
with the device. |
| 13.3. |
The label must bear the following particulars: |
| a) |
the name or trade name and address of the manufacturer. For devices imported into the
Community, in view of their distribution in the Community, the label, or the outer
packaging, or instructions for use, shall contain in addition the name and address of
either the person responsible referred to in Article 14
(2) or of the authorized representative of the manufacturer established within the
Community or of the importer established within the Community, as appropriate; |
| b) |
the details strictly necessary for the user to identify the devise and the contents of
the packaging; |
| c) |
where appropriate, the word 'STERILE'; |
| d) |
where appropriate, the batch code, preceded by the word 'LOT', or the serial number; |
| e) |
where appropriate, an indication of the date by which the device should be used, in
safety, expressed as the year and month; |
| f) |
where appropriate, an indication that the device is for single use; |
| g) |
if the device is costum-made, the words 'custom-made device'; |
| h) |
if the device is intended for clinical investigations, the words 'exclusively for
clinical investigations'; |
| i) |
any special storage and/or handling conditions; |
| j) |
any special operating instructions; |
| k) |
any warnings and/or precautions to take; |
| l) |
year of manufacture for active devices other than those covered by (e). This
indication may be included in the batch or serial number; |
| m) |
where applicable, method of sterilization. |
| 13.4. |
If the intended purpose of the device is not obvious to the user, the manufacturer
must clearly state it on the label and in the instructions for use. |
| 13.5. |
Wherever reasonable and practicable, the devices and detachable components must be
identified, where appropriate in terms of batches, to allow all appropriate action to
detect any potential risk posed by the devices and detachable components. |
| 13.6. |
Where appropriate, the instructions for use must contain the following particulars: |
| a) |
the details referred to in Section 13.3, with the exception of (d) and (e); |
| b) |
the performances referred to in Section 3 and any undesirable side-effects; |
| c) |
if the device must be installed with or connected to other medical devices or
equipment in order to operate as required for its intended purpose, sufficient details of
its characteristics to identify the correct devices or equipment to use in order to obtain
a safe combination; |
| d) |
all the information needed to verify whether the device is properly installed and can
operate correctly and safely, plus details of the nature and frequency of the maintenance
and calibration needed to ensure that the devices operate properly and safely at all
times; |
| e) |
where appropriate, information to avoid certain risks in connection with implantation
of the device; |
| f) |
information regarding the risks of reciprocal interference posed by the presence of
the device during specific investigations or treatment; |
| g) |
the necessary instructions in the event of damage to the sterile packaging and, where
appropriate, details of appropriate methods of resterilization; |
| h) |
if the device is reusable, information on the appropriate processes to allow reuse,
including cleaning, disinfection, packaging and, where appropriate, the method of
sterilization of the device to be resterilized, and any restriction on the number of
reuses. Where devices are supplied with the intention that they be sterilized before
use, the instructions for cleaning and sterilization must be such that, if correctly
followed, the device will still comply with the requirements in Section I; |
| i) |
details of any further treatment or handling needed before the device can be used (for
example, sterilization, final assembly, etc.); |
| j) |
in the case of devices emitting radiation for medical purposes, details of the nature,
type, intensity and distribution of this radiation. |
The instructions for use must also include details allowing the medical staff to brief
the patient on any contra-indications and any precautions to be taken. These details
should cover in particular:
| k) |
precautions to be taken in the event of changes in the performance of the
device; |
| l) |
precautions to be taken as regards exposure, in reasonably foreseeable environmental
conditions, to magnetic fields, external electrical influences, electrostatic discharge,
pressure or variations in pressure, acceleration, thermal ignition sources, etc.; |
| m) |
adequate information regarding the medicinal product or products which the device in
question is designed to administer, including any limitations in the choice of substances
to be delivered; |
| n) |
precautions to be taken against any special, unusual risks related to the disposal of
the device; |
| o) |
medicinal substances incorporated into the device as an integral part in accordance
with Section 7.4; |
| p) |
degree of accuracy claimed for devices with a measuring function. |
| 14. |
Where conformity with the essential requirements must be based on clinical data, as in
Section I (6), such data must be established in accordance with Annex X |
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