Is CE Mark required for Hand Sanitizers to be sold in Europe ?

[DannyK]

A North American company is looking to sell hand sanitizers in Europe. The hand sanitizers are anti microbial.

Is there a requirement for CE marking? If yes, to what directive.

What is the process for achieving approval to legally sell into Europe?

[Ajit Basrur]

In Reply to Parent Post by DannyK

A North American company is looking to sell hand sanitizers in Europe. The hand sanitizers are anti microbial.

Is there a requirement for CE marking? If yes, to what directive.

What is the process for achieving approval to legally sell into Europe?

I have moved your question to the CE section to get more directed responses.

Btw, this is a very interesting question and I was wondering if hand sanitizers are considered PPE (Personal protective Equipment)

[Gert Sorensen]

I had a look into this -and this is definitely a grey area.

Disinfectants for the medical field can be considered as an accessory to a medical device and labelled with a CE-mark awarded by a Notified Body in accordance with the Directive 93/42/EEG.

Disinfectants that are intended to be used for other purposes than in the medical field are called multi-purpose disinfectants and these are considered to be biocides according to the Directive 98/8/EC.

[JustinP]

The question is: who sells it in europe and who declares it as a medical product, if it was one. You will need an european representative who signs responsible for the european market.
Justin

[DannyK]

The company has a representative in Europe.

From my own research, the hand sanitizer can be dealt with under the cosmetics directive or if a claim is made as antimicrobial, it could be considered as a medicine.

Who could you contact to determine what is the best way forward?

Would it be a good idea to contact the Certification Body?

Thanks for your help.

[Ajit Basrur]

I think thats a better option ......and pl let us know too

[Persson - 2010]

In Reply to Parent Post by DannyK

A North American company is looking to sell hand sanitizers in Europe. The hand sanitizers are anti microbial.

Is there a requirement for CE marking? If yes, to what directive.

What is the process for achieving approval to legally sell into Europe?

DISINFECTANTS:
o used to disinfect the skin of patients are usually regulated as medicinal products, not medical devices.
o used by healthcare professionals to disinfect themselves (or other items not classified as medical devices), are usually regulated as
Biocides.