Irrigation Kits Labeling Guidelines

[Gangavaram]

Hi Members,

I have a Medical Device with carbamide peroxide bottle and saline can. This product is classified as Irrigation Kits in US.

Could some one help me with Labeling requirements / guideline for this type of products in EU.

Thanks a lot in advance for everyone's support.



Regards,
Pradeep

 

[Ronen E]

Hi Members,

I have a Medical Device with carbamide peroxide bottle and saline can. This product is classified as Irrigation Kits in US.

Could some one help me with Labeling requirements / guideline for this type of products in EU.

Thanks a lot in advance for everyone's support.



Regards,
Pradeep

Hi,

If it meets the Medical device definition in the MDD (42/93/EEC) --

‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

or the Accessory definition --

‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;

then the basic labeling requirements are as stated in Essential Requirement #13 (MDD annex I). Please note that the labeling should support compliance with all applicable Essential Requirements, as well.

Cheers,
Ronen.

 

[Gangavaram]

Hi Ronen,

Thanks a lot for the reply.

I have few more confusions and questions on this product on applicable regulations.

1. The product under question is Ear Drops with saline each having different expiry dates.
2. The marketing unit packed with the above 2 items carries the earliest expiry date.
3. Is there any regulation on listing expiry dates for these type of products
4. Any suggestion on classifying this product in EU.

Look forward to suggestions and comments.

Regards,
Pradeep

 

[Ronen E]

Have a look at MDD Aeticle 12.

Cheers,
Ronen.