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MDD Essential requirement checklist

By Kristen Spencer,2014-09-19 13:55
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MDD Essential requirement checklist

    MDD Essential Requirement Checklist

    ;In accordance to MDD 93/42/EEC appendix I for evaluation

Product Description

     Product Name

     Model

     Intend Use

Manufacturer

     Company Name

     Company Address

    Tel

    Fax

    Signature

    Compiled by: Date: (Name/Title/Dept.)

    Reviewed by Date: (Name/Title/Dept.)

    Approved by: Date: (Name/Title/Dept.)

    Clause Description N/A Standard/Sub-clause(s) Report/Document/ Comments Location

    I General requirement

    The devices must be designed and manufactured in such 1. 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.

This shall include:

     reducing, as far as possible , the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and

     consideration of the technical knowledge, experience, education and training and where applicable the

    medical and physical conditions of intended users (design for lay, professional, disabled or other users).

    The solutions adopted by the manufacturer for the 2. 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 cannot be eliminated,

     inform users of the residual risks due to any

    shortcomings of the protection measures adopted.

    Page 2 of 20

    When working with this document please refer to the Medical Devices Directive 93/42 EEC

    Clause Description N/A Standard/Sub-clause(s) Report/Document/ Comments Location

    The devices must achieve the performances intended by 3. 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.

    The characteristics and performances referred to in 4. 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.

    The devices must be designed, manufactured and 5. 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.

    Any undesirable side-effect must constitute an 6. acceptable risk when weighed against the performances intended.

    Demonstration of conformity with the essential 6a requirements must include a clinical evaluation in accordace with Annex X.

    II Requirements regarding design and construction

    Chemical, physical and biological properties 7

     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,

    Page 3 of 20

    When working with this document please refer to the Medical Devices Directive 93/42 EEC

    Clause Description N/A Standard/Sub-clause(s) Report/Document/ Comments Location

     the compatibility between the materials used and biological tissues, cells and body fluids, taking account

    of the intended purpose of the device.

     where appropriate, the results of biophysical or modelling research whose validity has been

    demonstrated beforehand.

    The devices must be designed, manufactured and 7.2. 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.

    The devices must be designed and manufactured in such 7.3. 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.

    Where a device incorporates, as an integral part, a 7.4. substance which, if used separately, may be considered

    to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon

    the body with action ancillary to that of the device, the quality , safety and usefulness of the substance must be

    verified by analogy with the methods specified in

    Annex I to Directive 2001/83/EC.

    For the substances referre to in the first paragraph, the notified body shall, having verified the usefulness of the substances as part of the medical device and taking account of the intended purpose of the device, seek a

    scientific opinion from one of the competent authorities

    Page 4 of 20

    When working with this document please refer to the Medical Devices Directive 93/42 EEC

    Clause Description N/A Standard/Sub-clause(s) Report/Document/ Comments Location

    designated by the Member States or the European Medicines Agency ;EMEAacting particularly

    through its committee in accordance with Regulation (EC) No 726/2004 on the quality and safety of the

    substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When inssuing its opinion , the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as

    determined by the notified body.

    Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the

    device as determined by the notified body.

    Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant

    medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of

    incorporation of the substance into the devices as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.

    When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has

    Page 5 of 20 obtained When working with this document please refer to the Medical Devices Directive 93/42 EEC

    Clause Description N/A Standard/Sub-clause(s) Report/Document/ Comments Location

    information on the ancillary substance, which could

    have an impact on the established benefit/risk profile of

    the addition of the substance in the medical device, it

    shall provide the notified body with advice, whether this

    information has an impact on the established

    benefit/risk profile of the addition of the substance in

    the medical device or not. The notified body shall take

    the updated scientific opinion into account in

    reconsidering its assessment of the conformity

    assessment procedure.

    Page 6 of 20

    When working with this document please refer to the Medical Devices Directive 93/42 EEC

    Clause Description N/A Standard/Sub-clause(s) Report/Document/ Comments Location

    The devices must be designed and manufactured in such 7.5. a way as to reduce to a minimum the risks posed by

    substances leaking from the devices. Special attention

    shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification,

    packaging and labelling of dangerous substances.

    If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of

    category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the

    device itself and/or on the packaging for each unit or ,where appropriate, on the sales packaging as a device containing phthalates.

    If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, withinthe instructions for use, information on residual risks for these patient groups and , if applicable, on appropriate precautionary measures.

    Devices must be designed and manufactured in such a 7.6. 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.

    Page 7 of 20

    When working with this document please refer to the Medical Devices Directive 93/42 EEC

    Clause Description N/A Standard/Sub-clause(s) Report/Document/ Comments Location

Infection and microbial contamination 8.

The devices and manufacturing processes must be 8.1.

    designed in such as 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.

    Tissues of animal origin must originate from animals 8.2. 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 transmissible agents must be addressed by

    implementation of validated methods of elimination or

    viral inactivation in the course of the manufacturing

    process.

    Devices delivered in a sterile state must be designed, 8.3. 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.

    Devices delivered in a sterile state must have been 8.4. manufactured and sterilized by an appropriate,

    validated method.

    Devices intended to be sterilized must be manufactured 8.5. in appropriately controlled (e.g. environmental) conditions.

    Page 8 of 20

    When working with this document please refer to the Medical Devices Directive 93/42 EEC

    Clause Description N/A Standard/Sub-clause(s) Report/Document/ Comments Location

    Packaging systems for non-sterile devices must keep the 8.6. 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.

    The packaging and/or label of the device must 8.7 distinguish between identical or similar products sold in both sterile and non-sterile condition.

Construction and environmental properties 9.

If the device is intended for use in combination with 9.1.

    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.

    Devices must be designed and manufactured in such a 9.2 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 ration,

    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 of for

    the treatment given,

    Page 9 of 20

    When working with this document please refer to the Medical Devices Directive 93/42 EEC

    Clause Description N/A Standard/Sub-clause(s) Report/Document/ Comments Location

risks arising when maintenance or calibration are not

    possible (as with implants), from ageing of materials

    used or loss of accuracy of any measuring or control mechanism.

    Devices must be designed and manufactured in such a 9.3. 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 sub-

    stances which could cause combustion.

    Devices with a measuring function 10.

Devices with a measuring function must be designed 10.1.

    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.

    The measurement, monitoring and display scale must 10.2. be designed in line with ergonomic principles, taking account of the intended purpose of the device.

    The measurements made by devices with a measuring 10.3. function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC.

    Protection against radiation 11.

General 11.1.

Devices shall be designed and manufactured in such a 11.1.1

    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.

    Page 10 of 20

    When working with this document please refer to the Medical Devices Directive 93/42 EEC

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