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Essential Requirements
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MDD 93/42/EEC - Annex 1
General Requirements
No.
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Essential Requirement
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Applies?
(yes/no/na)
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Response
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| 1. |
The device 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. |
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| 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:
- 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 shortcomings of the protection methods
adopted. |
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| 3. |
The devices must achieve the performance
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. |
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Essential Requirements
Medical Device Directive
93/42/EEC - Annex I
| 4. |
The characteristics and performance 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. |
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| 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 into account the
instructions and information provided by the manufacturer. |
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| 6. |
Any undesirable side effects must constitute
an acceptable risk when weighed against the performances intended. |
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II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
No.
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Essential Requirement
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Applies?
(yes/no/na)
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Response
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| 7 7.1 |
Chemical, Physical and Biological
Properties The devices must be designed, manufactured and packed 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. |
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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 the duration and frequency of the exposure. |
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Essential Requirements
Medical Device Directive
93/42/EEC - Annex I
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 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 those products and that their
performance is maintained in accordance with the intended use. |
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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 I 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. |
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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. |
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7.6 |
The 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. |
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Essential Requirements
Medical Device
Directive 93/42/EEC - Annex I
No.
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Essential Requirement
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Applies?
(yes/no/na)
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Response
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88.1 |
Infection and Microbial Contamination The
devices and their 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. |
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Essential Requirements
Medical Device Directive
93/42/EEC - Annex I
No.
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Essential Requirement
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Applies?
(yes/no/na)
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Response
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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. |
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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 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. |
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8.4 |
Devices delivered in a sterile state must have
been manufactured and sterilized by an appropriate, validated method. |
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8.5 |
Devices intended to be sterilized, must be
manufactured in appropriately controlled (e.g. environmental) conditions. |
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8.6 |
Packaging systems for non-sterile devices must
keep the product without deterioration in 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. |
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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. |
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Essential Requirements
Medical Device Directive
93/42/EEC - Annex I
No.
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Essential Requirement
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Applies?
(yes/no/na)
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Response
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| 9 9.1 |
Construction and Environmental
Properties 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 performance of the devices. Any restrictions on the use must be
indicated on the label or in the instructions for use. |
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9.2 |
Devices must be designed and manufactured in
such a way as to remove or minimize as far as possible: - the risk of injury, in
connection with their physical features, including the volume/pressure ratio, dimensional,
and where appropriate the ergonomic features,
- risks connected with reasonable 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 the materials used or loss of accuracy of any measuring or control mechanism. |
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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 which could cause combustion. |
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Essential Requirements
Medical Device Directive
93/42/EEC - Annex I
No.
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Essential Requirement
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Applies?
(yes/no/na)
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Response
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10 |
Devices with measuring function. |
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Essential Requirements
Medical Device
Directive 93/42/EEC - Annex I
No.
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Essential Requirement
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Applies?
(yes/no/na)
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Response
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11 |
Protection against radiation |
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Essential Requirements
Medical Device Directive 93/42/EEC -
Annex I
No.
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Essential Requirement
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Applies?
(yes/no/na)
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Response
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12 |
Requirements for medical devices
connected to or equipped with an energy source |
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Essential Requirements
Medical Device Directive 93/42/EEC -
Annex I
No.
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Essential Requirement
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Applies?
(yes/no/na)
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Response
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| 13 13.1 |
Information supplied by the manufacturer 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 user. 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 of each unit. If 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 instruction leaflet is needed for devices in Class I or Class IIa if
they can be used completely safely without any such instructions. |
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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. |
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Essential Requirements
Medical Device Directive
93/42/EEC - Annex I
No.
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Essential Requirement
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Applies?
(yes/no/na)
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Response
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13.3 |
The label must bear the following particulars:
- the name or trade name and address of the manufacturer. For devices imported into the
Community, the label, or the outer packaging, or the 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.
- the details strictly necessary for the user to identify the device and the contents of
the packaging.
- where appropriate, the word ‘STERILE’.
- where appropriate, the batch code, preceded by the word ‘LOT’ or the serial
number.
- where appropriate, an indication of the date by which the device should be used, in
safety, expressed as the year and month.
- where appropriate, an indication that the device is for single use.
- if the device is custom-made, the words "custom made device".
- if the device is intended for clinical investigations, the words "exclusively for
clinical investigations".
- any special storage and/or handling conditions.
- any special operating instructions.
- any warnings and/or precautions to take.
- year of manufacture of active devices, other than those covered by e). This indication
may be included in the batch or serial number.
- where applicable, method of sterilization.
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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. |
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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. |
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13.6 |
Where appropriate, the instructions for use
must contain the following particulars:
- the details referred to in 13.3, with the exception of d) and e).
- the performances referred to in Section 3 and any undesirable side effects.
- 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.
- 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.
- where appropriate, information to avoid certain risks in connection with implantation of
the device.
- information regarding the risks of reciprocal interference posed by the presence of the
device during specific investigations or treatment.
- the necessary instructions in the event of damage to the sterile packaging and where
appropriate, details or appropriate methods of re-sterilization.
- 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 re-sterilized and any restriction on the number of uses.
Where the 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 1.
- details of any further treatment or handling needed before the device can be used (for
example sterilization, final assembly etc.)
- 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 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:
- precautions to be taken in the event of changes in the performance of the device.
- precautions to be taken as regards exposure, in reasonable foreseeable environmental
conditions, to magnetic fields, external electrical influences, electrostatic discharge,
pressure or variations in pressure, acceleration, thermal ignition sources, etc.
- adequate information regarding the medicinal products which the device in question is
designed to administer, including any limitations in the choice of substances to be
delivered.
- precautions to be taken against any special, unusual risks related to the disposal of
the device
- medicinal substances incorporated into the device as an integral part in accordance with
Section 7.4
- degree of accuracy claimed for devices with a measuring function.
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| 14 |
Where conformity with the essential
requirements must be based on clinical data, as in Section 1 (6), such data must be
established in accordance with Annex X. |
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