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| In Vitro
Diagnostic Medical Device Directive
The In Vitro Diagnostic Medical Device Directive (IVDMDD), currently in draft, establishes how in vitro diagnostic (IVD) devices will be put on the market and in service. An In vitro diagnostic device is any medical device intended for use in vitro, (i.e., for the testing of samples derived from the human body). The in force date of the (IVDMDD) is January 1, 1997. More about the IVDMDD>> |
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For an update to the above mentioned draft, please download the following PDF file of the DIRECTIVE 98/79/EC of October 1998: About the European Union: Member States: The Agreement on the European Economic Area (EEA) extends the single market of the EU to Norway, Iceland and Lichtenstein. Switzerland is also included through bilateral agreements. More about the EU >> Languages: Medical Devices - The sector covers some 8000 types of products, ranging from simple bandages and spectacles, through life maintaining implantable devices, equipment to screen and diagnose disease and health conditions, to the most sophisticated diagnostic imaging and minimal invasive surgery equipment. More about EU Medical Devices >>
Definition of Medical Devices, accessory, manufacturer
The In Vitro Diagnostic Medical Device Directive (IVDMDD)
Table of Contents
IntroductionThe In Vitro Diagnostic Medical Device Directive (IVDMDD), currently in draft, establishes how in vitro diagnostic (IVD) devices will be put on the market and in service. An In vitro diagnostic device is any medical device intended for use in vitro, (i.e., for the testing of samples derived from the human body). The in force date of the (IVDMDD) is January 1, 1997. In Vitro Diagnostic DeviceA reagent, reagent product, calibrator, control, kit, instrument, equipment, or system, that is used alone or in combination. The draft includes accessories intended by the manufacturer to be used with the IVD device to achieve its intended purpose. The directive also applies to IVDs intended for professional or home use (i.e., for self-testing). LabelsImmediate ContainerThe packaging that protects the content(s) from contamination, and/or damage. Some examples are:
Required informationThe label of an immediate container should include the following information in a legible format:
ExemptionIf the device is too small for a label that is large enough to fit the minimum required information, or if the label would interfere with the readability of the results, the information may be reduced to:
Outer ContainerThe packaging that encloses the immediate container(s) to creating a single unit or an assembly of similar or dissimilar components. Required InformationThe label of the outer container should include the following
information in a legible format:
User InstructionsThe draft IVDMDD requires that each device be accompanied by the information that is necessary for its proper use. RequirementThe user instructions must be on the device itself or on the packaging of each unit, or, when appropriate, on the sales packaging. If full labeling of each unit is not practical, the instructions for use must be displayed on the packaging and/or the instruction sheet provided with one or more devices. ExemptionsDevices where, due to their training and experience, their users would be familiar with its proper use. Instructions for Use - ReagentsRequired InformationIn vitro diagnostic reagents must be provided with instructions for use. These are commonly supplied as a package insert. In special cases, they may be included in the outer container or in an operation manual (CEN, EN 375, p.8). The information is intended to ensure the proper and safe operation of the reagent. Reagents intended for self-testing, should include an explanation of the measurement of results and the follow-up action required. Information from the Label13.7 (a) The instructions for use must contain all applicable information required on the outer container, except:
As needed, some of the information contained in the label may be explained in greater detail in the instruction sheet. Other Information
Instruments and equipmentIn vitro diagnostic instruments also must be accompanied by instructions for use. Usually, these are supplied in the form of a user manual or operating instructions including the information necessary for the proper and safe operation, maintenance and basic troubleshooting of the instrument. The instructions of self-testing devices should be written in terms that are easy-to-understand. Required Information
Labeling of Devices with Hazardous SubstancesRequirementIVDs may include substances that are hazardous and regulated by the Classification, Packaging and Labeling of Dangerous Substances Directive (DSD). Such devices must be labeled clearly an indelibly with the following information: LabelingThe package label must include:
Hazardous SymbolsThe label of the inner and outer contained must contain the appropriate hazardous symbol and signal word. The symbol must be in printed in black on an orange-yellow background. For dangerous substances not yet listed in Annex I of the DSD, refer to the rules in Annex VI of the DSD.
* Symbols are for reference only and not official. Please refer to Directives 91/325/EEC and 92/32/EEC. **For official translations of signal words, Refer to Annex II of 91/325/EEC.Click here for a listing of language abbreviations used by the European Union. If a substance requires more than one symbolThen the requirement to display:
* Unless otherwise indicated in Annex I of the
DSD R-Phrases (Risk Phrases)Indicate the risks from the danger involved in using the substance. Refer to:
List of Risk Phrase codes and their meanings Under ED legislation,
data sheets contain codes for certain risk phrases, such as R1, R12,
etc. These phrases are
used in the classification, packaging, labeling and provision of
information on dangerous substances.
Click here to
download PDF file listing the
meanings of risk phrases.
S-Phrases (Safety Phrases)Indications for the safe use(s) of the substance. Refer to:
List of Safety Phrase codes and their meaningsUnder EC legislation, data sheets contain codes for certain safety phrases,
such as S1, S17 etc.
Click
here to download PDF file
listing the meanings of safety phrase codes.
The number that the European Commission (EEC) assigns to each specific substance is to be included in the label. EEC Label - The label of a product that contains a substance listed in Annex I of the DSD must include the statement "EEC Label". Small Label ExemptionsIf the substance is classified as:
and the package contains 125 mL (milliliters) or less, then the R- and S-Phrases do not have to be included on the label. Other ExemptionsIf the harmful substance is not retailed to the general public, then the label does not have to include R- and S-phrases. Note:Nontoxic>and non-harmful statements must not be included in the label of a product that contains a substance subject to the DSD. ApplicationA label containing the information required by DSD article 23 must be attached to one of more surfaces of the package, so the information may be read horizontally when the package is resting in its normal position. Minimum Label Sizes
ImplementationEach symbol must cover a minimum of one tenth of the label surface, but cannot be smaller than 2 cm2. The label must be attached to the package containing the substance. These measurements apply only to the display of the information required by the DSD and any other necessary health and safety statements. The required information may be printed on a label that is attached to the package or directly on the container. LanguagesMember states may require that the labeling specified in the DSD be printed in their official language or languages before the product is allowed on the market.Back to table of contentsOuter Packages Containing One or More Inner PackagesThe requirements are satisfied if the outer package complies with the labeling specification of international rules on the transport of dangerous substances. The label must also include all the information required by Article 23 of the DSD, except the "danger symbol". ExemptionsMember States may permit that :
Reference Source: International Labeling Requirements for Medical Devices, Medical Equipment, and Diagnostic Products - Charles B. Sidebottom, Interpharm Press, Inc., 1995 Useful Related Links:
CE Dictionary Copyright 1996 - 2008 InterSol, Inc. All Rights Reserved |
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