Regulation/Standard for Labelling in the UK - Medical Device Directions for Use

R

ramkannan13

#1
Hi All,

I would really appreciate , if the forum members can help me in Labelling- DFU .

What are the legal / regulatory requirement to be followd to write a CAUTION sign in the Direction For Use.

And also if someone can give an example how i can justify that i used so so.. so...section from this Regulation to say this is CAUTION sign and not WARNING sign .

P.S: Regulation/ Standards pertaining to the UK

:thanx:
Rk
 
Elsmar Forum Sponsor
S

SteveK

#2
Hi All,

I would really appreciate , if the forum members can help me in Labelling- DFU .

What are the legal / regulatory requirement to be followd to write a CAUTION sign in the Direction For Use.

And also if someone can give an example how i can justify that i used so so.. so...section from this Regulation to say this is CAUTION sign and not WARNING sign .

P.S: Regulation/ Standards pertaining to the UK

:thanx:
Rk
I basically think it up to you how you define the terms for the UK market. See:

http://www.precisionmedical.com/downloads/manuals/502444.pdf

Although it is a USA company, this manual I think gives a good example of how such terms are used i.e. giving the definition and then seeding them as appropriate throughout the document.:2cents:

Steve
 
R

ramkannan13

#3
Thanks Steve, Much appreciated! But still researching on the legal side of the CAUTION and WARNING. :thanks:
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Thanks Steve, Much appreciated! But still researching on the legal side of the CAUTION and WARNING. :thanks:
Hi,

I am not aware of any such formal partition into warnings and caution notes.
The obvious references to information supplied by the manufacturer would be Essential Requirement 13 (MDD annex 1) and EN 1041.

Cheers,
Ronen.
 
R

ramkannan13

#5
Hi,

I am not aware of any such formal partition into warnings and caution notes.
The obvious references to information supplied by the manufacturer would be Essential Requirement 13 (MDD annex 1) and EN 1041.

Cheers,
Ronen.
Thanks Ronen .
 
#6
I found a helpful article in the MDDI archives:

http://www.mddionline.com/article/are-your-product-safety-labels-state-art

(from April 2004)

It details the differing requirements for labels in the US and Europe. the US tend to use the "Signal Words" Danger / Warning / Caution whilst the European approach is the use of symbols in triangles or circles.

The Signal Words are defined in US standard ANSI Z535.4 The article explains the different meaning for each and the different colours to be used.

The European approach is based around the ISO 7000 database of symbols (Warnings / prohibitions/ mandatory actions).

The article goes on to explain how to make a label that satisfies both sets of requirements.

Hope this helps.
 
R

ramkannan13

#7
I found a helpful article in the MDDI archives:

http://www.mddionline.com/article/are-your-product-safety-labels-state-art

(from April 2004)

It details the differing requirements for labels in the US and Europe. the US tend to use the "Signal Words" Danger / Warning / Caution whilst the European approach is the use of symbols in triangles or circles.

The Signal Words are defined in US standard ANSI Z535.4 The article explains the different meaning for each and the different colours to be used.

The European approach is based around the ISO 7000 database of symbols (Warnings / prohibitions/ mandatory actions).

The article goes on to explain how to make a label that satisfies both sets of requirements.

Hope this helps.
Nice article on the Product Development Insight from legal and Regulatory perspective, very useful ! Many thanks :)
 

sagai

Quite Involved in Discussions
#8
Seems to me Warning is for events can end up in death or serious injuries, whilst Cautions are for the ones ending up in minor or moderate injuries.
I am not quite sure the article is valid about mandating any standard for this purpose, anyway.
Cheers
 
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