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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.