SBS - The best value in QMS software

Labeling Requirements in Part A Class IIb Medical Device Technical File

L

Lanwhere

#1
Hello experts:

I am updating the labeling section of a class IIb technical file. Our company used to list the label part numbers in this section. These labels are device identity label bearing CE mark & manufacturer information, warning labels, labels with electrical symbols, etc. this practice makes our work very difficult because the old labels are obsolete and new labels are created frequently each time we launch new models in the newly registered countries within or beyond EU territory.

I am wondering if it is necessary to list every label part number in the labeling section and add or delete the label part numbers when changes are made.

A more specific example is that we just created a label with a power supply direction symbol next to the power supply connector. Because the label is new, the new label part number has to be included in the technical file per our current practice. This label has been reviewed by our CB scheme lab and included in the CB report, which is reference in the labeling section of the ER checklist.

The NB-Med for technical file and design dossier does not specify what kind of labels should be included in the technical file part A. So different person has his or her own interpretation. TUV's technical file guidance recommends using labeling examples to demonstrate compliance.

Can you let me know 1) if this perticular power suppli label needs to be listed in the technical file part A; 2) what is the common practice to meet the labeling requirements in technical file part A.

This ia a simple question, but takes quite a few words to explain clearly (maybe clear as mad?). Your time and help will be greatly appreciated.

Thanks
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Labeling on the device is a technical information to the user. It is also a regulatory information. Let us first understand that this is very important in the technical file.
Next is to link your current labels directory directly in the technical file, and let the file reviewer to be able to view the label and all its contents.
Do not duplicate the work. Instead in your labeling section, make a mention to an annex folder that shows up all labels concerned to the devices in the technical file and keep that folder live.
 
Y

yana prus

#3
Great advice from Somashekar. I usually make a reference in Part A to the Part B where main regulatory labels are detailed, and make another reference in Part A to DMR where all the labels are listed.
 
Thread starter Similar threads Forum Replies Date
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
JoCam Labeling to Customer Requirements EU Medical Device Regulations 1
A Labeling - 2017/745 - EUMDR Requirements and Trademark Issues EU Medical Device Regulations 0
K Labeling requirements - Date of manufacture for software devices EU Medical Device Regulations 5
T Labeling Requirements - Creams in tubes EU Medical Device Regulations 3
E FDA Supplier Labeling Requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
M Putting AR's name and address on label - Authorized Representative Labeling Requirements CE Marking (Conformité Européene) / CB Scheme 0
I Requirements for different Labeling Levels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J FDA regulations vs. IEC 60601-1 Labeling Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M "Minor" Address Change Implications on Product Labeling Requirements Misc. Quality Assurance and Business Systems Related Topics 2
J ITA (Investigational Testing Authorizations) - Labeling requirements Canada Medical Device Regulations 1
C Labeling and UDI requirements for medical device kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Labeling requirements for procedure pack 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Labeling Requirements for Acquired Medical Device Inventory Other US Medical Device Regulations 2
B Labeling requirements for Servicing and Repairing Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 2
F MDD Article 12 Labeling Requirements for CE Marked Medical Device - Help CE Marking (Conformité Européene) / CB Scheme 4
Z Labeling Requirements for Free Samples supporting Clinical Evaluation EU Medical Device Regulations 2
D Sterile Medical Device Temperature and Humidity (Storage) Labeling Requirements EU Medical Device Regulations 5
JoCam Labeling Requirements for Medical Devices Made in China EU Medical Device Regulations 6
A Japan Medical Device Labeling Requirements Japan Medical Device Regulations 5
G Labeling requirements for individual units for medical devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
B Labeling requirements of Alcohol (Isopropanol) Swabs EU Medical Device Regulations 3
S GHS Labeling Requirements question Occupational Health & Safety Management Standards 6
Q CE-Labeling requirements: Year of manufacture for Software EU Medical Device Regulations 3
F 2015 Sudan Medical Device Registration and Labeling Language Requirements Other Medical Device Regulations World-Wide 3
J Medical Device Labeling and Symbols - US and EU Requirements CE Marking (Conformité Européene) / CB Scheme 6
D Automotive Labeling Requirements for LH and RH Parts IATF 16949 - Automotive Quality Systems Standard 4
K GHS (global harmonized system) Labeling requirements for Small Packages Occupational Health & Safety Management Standards 2
R Labeling, translation requirements including software interface: EU & other markets EU Medical Device Regulations 2
B Brazil ANVISA Medical Device Labeling/IFU Requirements Other Medical Device Regulations World-Wide 1
N Labeling Requirements for Medical Devices in Hong Kong Other ISO and International Standards and European Regulations 2
Y Labeling requirements for X-ray detector Other US Medical Device Regulations 1
S Class I Device - Reusable Instruments labeling requirements Imported Legacy Blogs 2
J IEC 60601 Third Edition Labeling Requirements - Section 5.2.2.1 (g) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T Measurement Equipment Shelf Rack Labeling Requirements question General Measurement Device and Calibration Topics 5
N DEHP/DHP Labeling Requirements TGA Other Medical Device and Orthopedic Related Topics 2
T IEC 60601 3rd Labeling Requirements and Software GUI IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P Thailand Medical Device Labeling Content Requirements Other Medical Device Regulations World-Wide 3
G Labeling Requirements - Medical Device is Rx in USA, non-Rx in EU 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number) EU Medical Device Regulations 7
W Calibration and Measuring Device Labeling Requirements Quality Manager and Management Related Issues 4
Y Medical Device Accessory Labeling Requirements Other Medical Device Regulations World-Wide 1
T Requirements for Private Labeling a Class III (PMA) Medical Device in the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Indian Labeling Requirements for Imported Medical Devices Other Medical Device Regulations World-Wide 9
L Medical Device Battery Labeling Requirements in the US US Food and Drug Administration (FDA) 1
J Own Brand Labeling NB (Notified Body) requirements EU Medical Device Regulations 3
M 21CFR820.120 Device Labeling Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T FDA Labeling Requirements Vs Health Canada Requirements Other US Medical Device Regulations 5

Similar threads

Top Bottom