REF symbol with product code in the IFU

kunal9218

Starting to get Involved
#1
Hi,
I am getting a push back from the Product Core team to not include REF symbol and product codes in the IFU. My point was that MDR requires REF in the IFU. Can someone please back me up with some valid explanation regarding the same?
 
Elsmar Forum Sponsor

rob73

looking for answers
#2
Actually the MDR only requires the name or trade name of the device, the labelling requires "the details strictly necessary for a user to identify the device" i.e. device part number (REF). Personally i think it is good practice to put all the information required to identify the device in the IFU.
 
Thread starter Similar threads Forum Replies Date
M Appropriate use of the REF symbol in IVD kits and kit components Other Medical Device Related Standards 2
K REF code and Consult IFU in Shipping carton boxes. EU Medical Device Regulations 1
S REF and CE mark symbols on multi-component device EU Medical Device Regulations 3
Rameshwar25 Linearity Study - Tolerance for which Ref Value Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
hogheavenfarm Reference Distance - Print which shows "1.656 REF" as a dimension Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
A Linearity and Eccentricity Point Definitions - Ref: ISO/IEC 17025:2005 ISO 17025 related Discussions 1
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
D Tolerance symbol Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
K Contains hazardous substance symbol EU Medical Device Regulations 1
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
A Read instruction manual - What Graphic Symbol must I use? US Food and Drug Administration (FDA) 7
E Stand-by vs. ON/OFF symbol IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K ISO 15223-1 Sterile barrier system - The 3-layer symbol EU Medical Device Regulations 1
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K EIFU indicator symbol - Class I labels as per EU MDR EU Medical Device Regulations 3
J Create your own symbol? Other Medical Device Related Standards 7
S ISO 18223-2 Temperature symbol in the Legend table in the Instructions for Use Other ISO and International Standards and European Regulations 4
K Medical Device Symbol(s) on Accessories EU Medical Device Regulations 28
shimonv Symbol for temperature limit EU Medical Device Regulations 6
echo7tango Circled-Z symbol on a syringe — what is it for, what does it mean? China Medical Device Regulations 21
V "Manufacturer Symbol on Device is missed due to space constraint" EU requirement EU Medical Device Regulations 11
J ISO 15223-1: Keep dry vs. humidity limitation label symbol Other Medical Device Related Standards 2
Z IFU (Instructions for Use) Symbol - 7010:M002 - can it be in black? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M GD&T tolerance or band? Using a symbol like parallelism // Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
J Use of Caduceus symbol on Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B Old GD&T Symbol "~" Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
O Can a Profile of a Surface have a Diameter Symbol? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Labeling/Marking Location for BF Symbol IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
F RFID Symbol for Medical Devices EU Medical Device Regulations 3
I Use of the Non-Sterile Symbol (EN980/ISO7000/ISO15223-1) Other Medical Device Related Standards 3
P CE Marked IVD Labelling Canada - Conformity symbol? Canada Medical Device Regulations 6
E Unfamiliar Blueprint Symbol - Hex Symbols Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
A Reference Source for Polarity Symbol Other ISO and International Standards and European Regulations 1
C CE Mark Label Symbol Requirements on a Medical Device CE Marking (Conformité Européene) / CB Scheme 3
A Does anybody know in which Standard can this attached Alarm Symbol be found? Other Medical Device Related Standards 3
B ISO 3864-4 Symbol Color Regulations Other ISO and International Standards and European Regulations 4
N Latex Free symbol for use in UK? EU Medical Device Regulations 3
K Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number) EU Medical Device Regulations 7
R Storage Symbol for Labeling ISO 13485:2016 - Medical Device Quality Management Systems 3
M US FDA Harmonization of Label Symbol Rules 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q Symbol Identification Help Other Medical Device Related Standards 14
J Symbol for manufacturing date - Is ISO 980 expired? CE Marking (Conformité Européene) / CB Scheme 11
N Symbol for Medical Device Sterile Packaging - "Inspect Seal Before Opening" Other Medical Device Related Standards 5
C Tolerance and Uncertainty have the same Symbol - How to Calculate the Tolerance Measurement Uncertainty (MU) 1
S Medical Device Labeling - Is there a Thermo Disinfector/Washer Symbol Other Medical Device Related Standards 7
B Do we need to put the box around the SN symbol listed in EN 980? Other ISO and International Standards and European Regulations 5
A Medical Device Labeling - Non-Pyrogenic Symbol Other Medical Device Related Standards 6
N Unknown Medical Symbol in Product Label ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom