Follow Us:

EU

Home Medical Device Symbols
Quick Contact

    MDR TECHNICAL FILE GAP ASSESSMENT

    We identify the GAPs and Guide appropriate measures

    Medical Device Symbols

    Medical Device Symbols to be used with medical device labels when supplied. These symbols are a part of the regulatory requirements by leading regulatory bodies including the EU and US FDA.

    Applicable Harmonised Standards

    • EN 1041:2008: Information supplied by the manufacturer of medical devices.
    • EN 15986:2011: Requirements for labeling of medical devices containing phthalates.
    • EN ISO 3826-2:2008: Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets.
    • EN ISO 15223-1:2012: Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.

    Symbols used in Active & Non Active Devices

    Manufacturer Logo

    Manufacturer

    DateofManufacture

    Date of Manufacturer

    Use by Date

    Use by Date

    EC Representative

    EC Representative

    Batch Code

    Batch Code

    Catalogue Number

    Catalogue Number

    Serial Number

    Serial Number

    Sterilize

    Sterilize

    Sterilize Use Aseptic Processing

    Sterilize Use Aseptic Processing

    Sterilize Use Ethyleneoxide

    Sterilize Use Ethyleneoxide

    Sterilize Use Irradiation

    Sterilize Use Irradiation

    Sterilize Use Steam Dryheat

    Sterilize Use Steam Dryheat

    No Resterilize

    No Resterilize

    No Reuse

    No Reuse

    Medical Device Symbols 1

    Nonsterile

    Instruction For Use

    Instruction For Use

    Caution

    Caution

    Natural Rubber Latex

    Natural Rubber Latex

    Damaged Pack

    Damaged Pack

    Sterile fluid Path

    Sterile fluid Path

    Medical Device Symbols 2

    Fragile

    Sunlight Away

    Sunlight Away

    Heat Radioactive Away

    Heat Radioactive Away

    Keep Dry

    Keep Dry

    Temperature Low limit

    Temperature Low limit

    Temperature Upper limit

    Temperature Upper limit

    Temperature Limit

    Temperature Limit

    Humidity

    Humidity

    Atmospheric Pressure

    Atmospheric Pressure

    Biological Risk

    Biological Risk

    Unique Device Identifier

    Unique Device Identifier

    Medical Device

    Medical Device

    Translation

    Translation

    Sterilized Vapourized Hydrogen Peroxide

    Sterilized Vaporized Hydrogen Peroxide

    Single Patient Multiple Use

    Single Patient Multiple Use

    Repackaging

    Repackaging

    Patient Information Website

    Patient Information Website

    Patient Identification

    Patient Identification

    Medicinal Substance

    Human Blood Plasma Derivatives

    Healthcare Centre Doctor

    Healthcare Centre Doctor

    Biological Material Animal Origin

    Biological Material Animal Origin

    Biological Material Human Origin

    Biological Material Human Origin

    Hazardous

    Hazardous

    Non Pyrogenic

    Non Pyrogenic

    In Vitro Diagnostic

    In Vitro Diagnostic

    Sampling Site

    Sampling Site

    Disclaimer

     

    The above Medical Device Symbol images are not in required pixels or size and not the exact representation of standard. The above information is intended for informational purposes only and should not be construed as legal advice for regulatory submissions.