EU Definition of Labeling or the meaning of the MDD (Medical Devices)

[fialor]

Hi All,
Could anyone point me in the right direction for definition or guidance on labelling within the EU or the meaning of the MDD?
I undertstand the requirements of the FDA as regards ;abelling but cannot seem to find anything on the EU?
Thanks

 

[amjadrana]

Dear Fialor,

MDD means Medical Device Directive with the details below. You have to fulfill these requirements according to MDD before you can place your medical devices on market in the EU:

COUNCIL DIRECTIVE 93/42/EEC
of 14 June 1993
concerning medical devices
(OJ L 169, 12.7.1993, p. 1)

Amended by:

►M1 Directive 98/79/EC of the European Parliament and of the Council of
27 October 1998
L 331 1 7.12.1998
►M2 Directive 2000/70/EC of the European Parliament and of the Council of
16 November 2000
L 313 22 13.12.2000
►M3 Directive 2001/104/EC of the European Parliament and of the Council
of 7 December 2001
L 6 50 10.1.2002
►M4 Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003
L 284 1 31.10.2003
►M5 Directive 2007/47/EC of the European Parliament and of the Council of
5 September 2007
L 247 21 21.9.2007

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF

The consolidated copy that includes all amendments can be obtained from the link above. In case the link does not work, please copy and paste in your browser.

The labelling requirements for EU are detailed in Article 17 regarding placing of CE Mark and in Annex I - Essential Requirements (paragraph 13 deals exclusively with labelling requirements).
I hope this information will be starting point for you.

Amjad Rana

 

[fialor]

Thank you Amjadrana.

I think my question may have been a bit too vague. I am very familiar with the MDD requirements as regards labelling.

My question is "Does the MDD or other Guidance Documents in the EU define Labelling?"
The MDD uses Labelling a number of times in the directive but I have not yet come across any document that offers up a definition of it in teh EU.
Perhaps someone else has?

Thanks for the response.

 

[Marcelo]

As far as I remember, nor the Medical Device directives nor related guidance documents have a definition for labelling. Please note that some directives, such as the Textile directive, do have a definition.

The text of the proposed new regulation has the following:

‘label’ means the written, printed, or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;

 

[fialor]

Marcelo Antunes thanks.
I was rather hoping that the term would have been defined elsewhere.
Fialor

 

[Marcelo]

I was rather hoping that the term would have been defined elsewhere.

My impression is that it is defined elsewhere. There are some directives (such as the CE Marking Directive) that also apply when you apply any Directive. However, I did a quick search today and did not found any definition (and I'm pretty sure I did this before).

On the other hand, the fact that some other Directives do have a definition may mean that there's no general definition.

 

[AneMedDev]

Hi!

Maybe you can find something in this document from 2011:
- Label and Instructions for Use for Medical Devices - GHTF
It is defined as 'historic information' on their website, but maybe it can help you anyway.

 

[paulag]

The draft EU Medical Device Regulation defines "Label" as