According to classification rule 15 of the EU Medical Device Directive:
Rule 15
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class IIb.
All devices intended specifically to be used for disinfecting medical devices are in Class IIa. Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.
This rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action.
So, in the EU, depending on the intended use, your HLD can be a class IIa or IIb.
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Andrea Sparti
Regulatory Affairs Manager
Bienne
Switzerland
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Original Message:
Sent: 06-Apr-2018 08:09
From: PURVI GORADIA
Subject: High Level Disinfectant Classification
Hello,
From your comments , I understand that HLD that you are referring is an equipment sterilant and or surface disinfectant.
As per EU classification rules, this will be categorized under Class "B".
Whereas as per GHTF, it is classified as "Class II b".
The countries that you mentioned, refers more or less that the above classification system for HLD.
However, it will be prudent to get final confirmation from respective countries regulatory authority before doing regulatory filing.
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PURVI GORADIA
Manager Regulatory Affairs
Mumbai
India
Original Message:
Sent: 04-Apr-2018 17:43
From: Anonymous Member
Subject: High Level Disinfectant Classification
This message was posted by a user wishing to remain anonymous
Hello Regulatory Colleagues!
I am in search of an easy method to determining the medical device classification of a high level disinfectant (HLD) in the EU, Brazil, China and Japan. Is anyone aware of what the medical device classification may be in these regions or the best way to locate this information? Please note, the HLD will used on medical device hard surfaces only.
Thanks!