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Whether the medicine spoon, medicine dropper and NASAL ASPIRATOR are medical devices

Pauling

Involved In Discussions
#1
Hi,

Our client want to pack below items together to sold in EU as Medical Set:
1.Thermometer

2.CLIPPER and Scissors
To keep nails short and smooth so babies won't scratch themselves

3.Medicine SpoonTo hold and give the medicine to child.

4.Medicine Dropper
To administer midicine(with dosage marking)

5.NASAL ASPIRATOR
Congestion due to colds is uncomfortable for a baby. The nasal aspiratior will gently relieve baby's discomfort by removing excess mucus to help your baby breath easier.

All above item are under the scope of medical device in US market. Would you pls help to check whether above items in blue are medical device or not in EU?
What requirements should they comply with?

And if pack thermometer class 2 medical device with other product not medical device or class 1 medical device, should the package remark both "CE with NB CODE" and "CE"?

Look forward to your reply.:thanx:
 

arios

Your Mexican Amigo
#2
Re: Whether the medicine spoon, medicine dropper and NASAL ASPIRATOR are medical devi

With regards to the spoon and the medicine droper, I consider the following section of MDD 93/42/EEC Art. 1 applicable:

"3. Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC (1), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product."

Both Class I Medical Devices on the basis of Rule 5 of the Annex IX

I have some doubts with regards to the Class for the nasal aspirator, but in my opinion it is a device as well, most likely a Class I also.

Direction on the req's for class I devices comes from Art 11:

"5. In the case of devices falling within Class I, other than devices
which are custom-made or intended for clinical investigations, the
manufacturer shall, in order to affix the CE marking, follow the
procedure referred to in Annex VII and draw up the EC declaration
of conformity required before placing the device on the market."

Essential requirements of Annex I apply too. Annex VII provides direction for devices with a measuring function
 
Last edited:

Ajit Basrur

Staff member
Admin
#3

xcanals_tecno-med.es

Involved In Discussions
#4
Re: Whether the medicine spoon, medicine dropper and NASAL ASPIRATOR are medical devi

Hello Pauling

You need to establish first of all that the product is a medical device according the European definition of MEDICAL DEVICE stated in the directive 93/42/EEC.

The previous answer is not accurate:
"The definition of medical device is standardized world across, so if its a device in US, it will be a medical device in EU as well"
for example a "menstrual tampon" is a medical device in USA and not in Europe

For the classification of the device you mus follow the annex IX rules and also the MEDDEV guidelines referenced

Let me answer in short to your questions:

1.Thermometer : (electronic, the mercury is banned) medical device class IIa rule 10
2.CLIPPER and Scissors : Not medical device, needs to fulfill the MD definition, review the intended use and include more detail
To keep nails short and smooth so babies won't scratch themselves

3.Medicine Spoon (with dosage marking) To hold and give the medicine to child.
medical device class I with measuring function rule 2

4.Medicine Dropper
To administer medicine(with dosage marking)
medical device class I with measuring function rule 2

5.NASAL ASPIRATOR
Congestion due to colds is uncomfortable for a baby. The nasal aspiratior will gently relieve baby's discomfort by removing excess mucus to help your baby breath easier.
medical device, needs to fulfill the MD definition take care with the intended use. medical device class IIa by rule 11

6. What requirements should they comply with?
You need to establish a Technical File and a ISO 13485 quality system
and obtain a certificate by a NB Notified Body (except for class I products non sterile and w/o a measuring function)
Also remember to include an European Representative in yor labeling (obligatory from 21 mars 2010 acc dir 2007/47/EC)

7. And if pack thermometer class 2 medical device with other product not medical device or class 1 medical device, should the package remark both "CE with NB CODE" and "CE"?
a) You may include both in your NB presentation as "XXXX SET" and the higuher rule prevails (so CE with NB code must be on the package and labelling)
b) or also can be packed together following the procedure pack of article 12
I recommend you the a) route

Regards

Xavier :)
 


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