Legislation

Current legislation

Medical Devices are regulated by three main Directives:

Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
[158 KB]
The Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
[265 KB]
Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998)
[188 KB]

Active implantable medical devices

In vitro diagnostic medical devices

(Other) Medical devices

Original directive

Directive 90/385

Directive 98/79 pdf

[347 KB]

Amendment 1

[347 KB]

Amendment 2

Directive 93/68

Directive 2000/70

Amendment 3

Regulation 1882/2003 pdf

[218 KB]

Directive 2001/104

Amendment 4

Directive 2007/47

Regulation 1882/2003 pdf

[218 KB]

Amendment 5

Directive 2007/47 pdf

[185 KB]

Latest consolidated version

11.10.2007 pdf

[158 KB] including amend ment No. 4

20.11.2003 pdf

[188 KB] including amend ment No. 1

11.10.2007 pdf

[265 KB] including amend ment No. 5

Latest but one consolidated version

20.11.2003 including amend ment No. 3

20.11.2003 including amend ment No. 4

You can find more detailed information about the medical devices legal framework on these following pages:

source

Bottle/Nipple

Teething & Soothing

Medical Device

Feeding & Fun Cutlery

Gift Set

Enter Your Email Id

Nurturing Care

When it comes to baby care and bringing up a healthy, happy baby, the requirements are pretty simple-just a little bit of knowledge and a whole lot of love. While you supply the love, we can help with the knowledge and products.

Medical devices have assumed an even greater importance in care and welfare and often play a decisive role for diagnosis and treatment. Nuby offers many quality products in Medical Devices, Hygiene and Mother Care category and each product carries out internal checks to ensure that they must meet their requirement. For ensuring heath and safety, each product pack has safety and quality information.

Medical Devices :

Nasal aspirator :

The pediatrician recommended method for immediate relief of nasal congestion in infants is aspiration.
This simple, effective procedure uses the gentle suction provided by first squeezing the bulb portion of the aspirator, then placing the end gently against baby's nostril and releasing the pressure on the bulb & after this clean tip's matter.

Medicine dropper/Bottle/Spoon

Ensures accurate dosage
Enables children to take there medicines themselves

Hygiene

NÛBY™ Disposable wet wipes are Alcohol free, meant for babies and toddler’s soft skin, contains jojoba oil for moisturizing effect and is dermatological tested which gives an assurance of quality.
Cotton swabs with an option of Stopper buds, makes it comfortable for a mother to use for the baby and pre-sterilized cotton makes it germs proof.

Mother's Comfort

The Nuby Nipple protector is designed to help alleviate a mother’s sore and chapped nipples during breast feeding.
It features a soft tringular shape that encourages the natural contact between mother and child.
Since the protector is both tasteless and odorless , a baby is better exposed to their mother’s natural scent.
This soft silicone not only allows the nipple protector to fit cofortably, It helps to ease the transition from breast feeding to bottle feeding.

Medical Kit

Nuby offers many products under this category like Digital Thermometer, Nasal Aspirator, Ear Cleaning Syringe Set with Tip made of soft TPE, Medicine Spoon, Medicine Dropper, Syringe and Medicine Bottle with Silicone Nipple.