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MEDDEV. 2.14/3 rev.1
January 2007
GUIDELINES ON MEDICAL DEVICES
IVD GUIDANCES: Supply of Instructions For U (IFU) and other information for
In-vitro Diagnostic (IVD) Medical Devices
A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
Note填表防疫
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This guideline is part of a t relating to the application of EC Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVD Directive). It is not legally binding but has been jointly drafted by various interested parties including Competent Authorities, the European Commission rvices and industry. As such it can be taken as reflecting positions taken by tho stakeholders in the medical device ctor and it is anticipated that they will be followed within the Member States and help ensure uniform application of relevant provisions of the Directive.
1.0 Introduction
Annex I, ction 8.1 of the IVD Directive 98/79/EC requires manufacturers, to supply the information necessary for the safe and proper u of the device but does not provide a lot of details on how this should be done (Annex I, ction 8.1 also indicates that in duly justified and exceptional cas no such instructions for u are needed for a device if it can be properly and safely ud without them).
Currently most instructions for u (IFU) are provided in paper format. However, the documents can be very lengthy due to the need to include multiple printed versions in all the required languages. Also, the cost of using paper can be high to both manufacturers and the environment. Given that most IVDs are ud by healthcare professionals in a clinical environment, with relatively c
ommon access to computers and internet facilities, the possibility of issuing the IFU for professional urs in a format other than paper for example, by CD-Rom or DVD or through different means of supply, for example, an Internet website, has been raid.
2.0 Scope
This guideline has been developed to advi manufacturers on how to provide IFUs and other information for the safe and effective u of IVDs while taking into account any limitations or safeguards to be employed appropriate for the ur population and the media or means of supply chon. It should be read in association with the labelling requirements of Annex I, ction 8 of the IVD Directive 98/79/EC and with the language requirements of the transpositions of article 4(4) of the IVD Directive 98/79/EC by the Member States.
3.0 Definitions
Instructions For U (IFU)
Information provided by the manufacturer to inform the device ur of the product’s proper u and of any precautions to be taken as outlined in Annex I of the IVD Directive 98/79/EC.
Different media: other than paper form, e.g. CD-Rom, DVD, etc.
Different means of supply: provision of IFU by sales force, fax, internet, etc, rather than by inclusion of paper IFU with the device itlf.
Layperson
An individual who does not have formal training in a specific field or discipline (Source ISO 15197 and GHTF SG1 N043). (Training received by a diabetic patient for the safe u of, for example, a gluco meter would not constitute “formal training” in the context of this definition.
Professional U
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U by personnel who have received specialid education and training with regard to procedures utilising in-vitro diagnostic medical devices (Source EN 375).
Point of Care Testing
Testing that is performed near or at the site of a patient with the result leading to a
possible change in the care of a patient. (Source ISO 22870)
Self-Testing
U in the home or similar environments by a layperson who will relate the results of the test to him or herlf (Source EN 376).
4.0 Provision of the IFU for an IVD
The IVD Directive 98/79/EC clearly states that each IVD must be accompanied by the information needed to u it safely and properly taking into account the training and the knowledge of the potential ur. The format in which the IFU shall be supplied is not specified in the IVD Directive. However, the stakeholder connsus is that the appropriate media and means of supply is dependant on the category of urs.
IVDs can be split into two major categories with respect to their ur :
IVD for lf testing
IVD for professional u
4.1 IVDs for Self-Testing
The IVD Directive defines such devices as tho intended by the manufacturer for u by laypersons in a home environment. Such a ur need have no formal education and / or training in using IVD tests. Self-test IVDs may be single u pregnancy tests or may be ud regularly by a layperson to monitor and control a particular glucometers for diabetes. Typically, the result is ud directly by the ur who is the patient.
IFUs for IVDs to be ud principally by laypersons shall always be provided in a paper format with the device. This is becau the ur needs ready access to the IFU but cannot be assumed to have access to the necessary information technology systems to access an electronic format or to obtain the IFU by other means.
4.2 IVDs for Professional U
In general, the IVDs are ud in a healthcare medical laboratory, by professionals who have a formal education and experti in performing IVD tests and using IVD instrumentation. The IVD tests are typically carried out repetitively and in a routine tting as part of a healthcare rvice to the patient. Test results are interpreted by a healthcare professional as part of the clinical management of a patient.
The IFU for IVDs intended for professional u can be provided in either paper or non paper form or be supplied by different means such as:
providing a free of charge telephone number that can be contacted to have the IFU faxed, mailed or e-mailed
making the IFU available at a fax call in number: fax polling
making it available through a designated internet website
or distribution through local sales organisation
Where the manufacturer elects to supply the IFU in a format other than paper, he shall provide a ‘free of charge’ contact number that can be ud in order to have the IFU faxed, mailed or e-mailed to the ur.
Exception
IFUs for IVDs that are specifically intended by the manufacturer for u at point of care shall be provided with each device in paper format. This is becau there may not be ready access to information technology systems at the point of u of the IVD.
5.0 Instructions for U for Reagents, Reagent Kits, and Specimen Receptacles
This ction outlines the conditions for the provision of the IFU in a format other than paper and the minimum information that shall accompany an IVD if a manufacturer choos to provide the IFU by other means of supply. In all cas the manufacturer shall comply with the labelling requirements outlined in Annex I, ction 8 of IVD Directive 98/79/EC and with the language requirements of the transpositions of article 4(4) of the IVD Directive 98/79/EC by the Member States.
Note: Under article 10.2 of the IVD Directive, the manufacturer may be requested by the Competent Authority to provide information on the labelling and the IFU. The information provided at that moment should be equal to what is provided to the ur irrespective of the media or means of supply.
5.1 Conditions for the Provision of an IFU by other Media or Different Means of
Supply
刑法修正案九1. The device must only be ud as outlined in ction 4.2
2. The manufacturer must ensure the proper design and function of the IFU for all media and
means of supply and document the verification and validation of same as part of the quality system. This should be reviewed by a Notified Body, if applicable, as part of the conformity asssment process.
3. The manufacturer, informed by the views of healthcare professionals, must have carefully
平等王considered as part of his risk management, the risks associated with the provision of the IFU by other media and means of supply especially in light of the product usage and the professional urs’ need. This should be reviewed by a Notified Body, if applicable, as part of the conformity asssment process.
4. The ur should be informed via the catalogue and / or the device labeling and / or any
other appropriate communication that the IFU for the device will be supplied by other means to ensure that the ur will have the IFU at the moment of u including any necessary equipment to read the IFU.
5. Where IFUs are posted on an internet website, manufacturer must comply with the
additional requirements as defined in ction 5.3 below.清脆的反义词
6. The manufacturer must have a system in place to provide in a timely manner a paper
version of the IFU on request by the ur at no additional cost.
7. The manufacturer must comply with the information requirements as defined in ction 5.2
below when the IFU is provided by different means of supply.
8. For revisions to the IFU there shall be a clear indication on the device label to indicate to
the ur that the IFU has been changed by reference to the latest revision.
9. If a revision to the IFU is necessary due to a field safety corrective action the manufacturer
must ensure that each ur of the device, that is already placed on the market, is informed about the change and provided with either the information on how to obtain the latest version of the IFU by other means or be provided with the IFU as a paper copy or other appropriate media.
5.2 Information to be Supplied with IVD when the IFU is Supplied by Different Means of
Supply
The following information shall be supplied with each device when the IFU is provided by other means:
The name and address of the manufacturer or authorized reprentative
The various options to obtain, free of charge, the applicable version of the IFU, except when provided with the initial delivery of the instrument in a controlled way.
A unique reference (and any other information needed by the ur) to identify the right
version of the IFU. This reference should allow the ur to retrieve the applicable IFU using any of the options provided.潜伏在办公室
When the IVD is considered dangerous for the ur (e.g. chemical, radioactive and/or biological risk), the outer container should include the appropriate hazard symbol(s) and the corresponding risk and safety phra numbers. But in ca of specific biological risk, e.g.
where an IVD reagent includes substances of human or animal origin, or when no symbol is available, a warning should be given in the additional information supplied with each device concerning their potentially infectious nature taking into account the risk pod by the nature or amo
unt of the substances.
Where appropriate, any batch specific related information not provided in the IFU obtained by other means (e.g. the value of a certain parameter to be ud on an instrument or any specific ttings to be ud on a particular type of instrument etc).
In ca of revision to the IFU a clear indication on the device to alert the ur that IFU has changed. This also applies in situations where the IFU is changed as a result of a safety field corrective action.
This information can appear on the device label if space permits or can be provided on a parate sheet included with the device.
The following is an example of how this information may be prented with an IVD when the IFU is provided by other means of supply:
Note 1: This is only an example and is not binding for format or content.
5.3 Internet Website – Additional Requirements for Provision of IFU
