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BASIC OF MEDICAL DEVICE LABELLING - Coggle Diagram
BASIC OF
MEDICAL DEVICE LABELLING
Basic of Label
Label
written, printed, electronic, graphic matter affixed to MD/its packaging system/accompanying a MD
To ensure product quality & safety
Types of Content in Labeling
Variable content
Varies across each document
Created at point of implementation of the asset
Fixed content
Remains same across all docs
Implemented in the original design of the asset
Contents of
the Label
How the device should be used, maintained & stored
Any residual device risk, warnings, limitations or contraindications
Intended use/purpose of the device
Sterilization details
Traceability details
UDI details
Importer / Distributor / translator identity
Labeling commensurate with the technical knowledge, experience, education or training of intended users
Manufacturer identity
The avoidance of prescriptive country-specific requirements for text, content, format of labeling that offers no benefit to the device user or, where applicable, the patient
Device identity
Level of Labelling
Primary Label
Secondary Label
Tertiary Label
Process involved in labelling
[3] Remediation of Gaps
Find the solution for the gaps
Complete/Partial Gap --> No Gap
[4] Redlining of Gaps
Graphical representation of gaps
Recommended tools
Adobe Illustrator
Adobe Acrobat pro
[2] Labeling Gap Assessment
the process of systematically examining a medical device's clinical evidence portfolio to determine whether it demonstrates conformity with all relevant requirements. it is a crucial 1st step in developing and maintaining an regulatory compliance strategy
[5] Graphical Updation of Labels & IFU
(Graphic Updation, Proof reading & Submission)
Once updates completed
Files will be shared with Pfroof reader for review
After proof readers approval
files will be uploaded in PLM or submitted to notified body
Based on the redlines
Graphic Designer will update the Labels, IFUs, Manuals
(tools: Adobe Illustrator, Adobe InDesign, Adobe frameMaker)
[1] Input study & Input data collection
Input study
What product is
Classification product
Type of product
Manufacturing details
Label types
Packaging details
Input data collection
Product Drawings
Risk Benefit Analysis docs
Label & IFU
Clinical Evaluation Report
Packaging
Safety Data Sheets
Technical Documentatiosn (STED)
Instruction For use (IFU)
Infor by manufacturer to enable safe &proper of an MD
is portion of the
accompanying information
that is essential for the safe and effective use of a MD or accessory directed to the user of the MD
is might be provided in the booklet format or paper insert
for some devices: IFU might be not required in case of the person or the user familiar with how to use the device
IFU need to educate the intended user about the device and it need to help intended user to use the device
Content of IFU
Manufacturer (Manftr)
Name & address of
manftr
with the appropriate symbol need to be mentioned in the IFU
In case of the European Union, if the legal
manftr
is not located within Europe means, they also need to include the EC REP (European comission Representative
Identification of the MD
Name does not uniquely identify MD, an additional means shall also be given (catalogue/ ref number)
Device contains modules or software's - need to be identified by name and its version
Name of MD need to be mentioned to identify device
Intended Use and user
Intended use: purpose of device to be used
Benefits and limitations with respect to the intended use need to be mentioned
Storage & handling
Environmental requirements & handling/ storage conditions
Warning & precautions
Residual risk (installation, operation, maintenance, transportation, storage, disposal
known interferences that present significant risk
Instrument installation
Should be mentioned when users carried out installation
Infor on available accessories including proper connectivity
Action upon delivery
Site preparation prior installation
Bringing into operation
Theory of operation
Basic principles of the technology used in instrument operation
Functions
(for each MD func)
the subsystems & their perpose
functinal specifications for major subsystems
Performance of MD
Ability of device to achieve intended perpose
Limitations of use
Preparation prior to operation
Ordering Infor for accessories & consumables
Instrument checks for safe & correct operation (including calibration)
Special materials/equipment requied
Hardware adjustments
Any training of user
Apart from these all other prior actions required
Operating procedure
Shall include all phases of the operation
Detaiiled description
Control procedure
Adequate infor about the performance of MD & a means verify it performs within specifications
Special functions
Data output, notation, storage, security, transfer
Special setting
Automatic features
Interface protocol
Shut-down procedure
Switching the MD off
Temporarily taking MD out of operation
Placing MD on stand-by
Maintenance
Guisdance on sterilization, decontamination or disinfection - by user
Components list (working materials & tools)
Instruction for cleaning (compatible materials, procedure, frequency) - by user
Servicing contact infor
Preventive maintenance (nature & frequency) - user
Recommended spare parts & consummables - replaced by user
Troubleshooting
Malfunctions that can be correct by user
Malfuncs necessitating service calls
Determining causes of common malfuncs
Measures to be taken in the event of a change in the performance characteristics of MD
Interpretation of malfuncs messages
Disposal Infor
Safe disposal of hazardous waste materials, accessories & instruments at their end of life
Standards
ISO 15223-1:2021
ISO 15223-1:2021, MDs
Symbols to be used with MD labels, labeling & infor to be supplied
Part 2: Symbol development, selection and validation
EN ISO 20417, MDs
Infor to be supplied by the manftr
IEC 60878
Graphic symbols for Electrical equipment in the Medical Practice
ISO 14971:2019, MDs
Application of risk mgmt to MDs
ISO 13485:2016, MDs
Quality mgmt systems (QMS)
ISO 7000, database
Graphical symbols for use on equipment - Registered symbols
Symbols
Manufacturer
Sterilitty
Storage
Safe Use
IVD-specific
Transfusion/Infusion
Others
Software's used
Prisym ID
EASYLABEL
BarTender
TEKLYNX
LOFTWARE
NiceLabel
Introduction to MD