Single Use Disposable Dental Syringe - CE Marking Advice

P

Pureason

#1
Hello

I am new to the forum and imagine this question had been asked a number of times previously. A search on here has resulted in lots of results therefore I have decided to start a new thread for advice.

We have designed a single use disposable dental syringe similar to the one featured here 'www dot hynodent dot ch' made of polypropylene (same material as regular syringes). We plan to outsource manufacturing to an existing syringe manufacturer who produces regular medical syringes and has CE approvals for his products. I would like to CE mark my product to include my name on the packaging. I would like to understand the below:

  • What is the CE classification of a product such as hynodent. The device will only be used in the oral cavity and will not include an anaesthetic cartridge or sterile needle. It will only consist of plastic components.The anaesthetic solution will physically not come in contact with the device as it will be channelled through the needle.Can it be classified as a class I non-sterile and non-measuring medical device? and be CE marked through self certification?
  • If the medical device can be classified as class I non-sterile and non-measuring, can the product be sterilised to ensure it is clinically clean for used but not labelled as sterile or is sterilisation not permitted if the product is CE marked as class I non-sterile and non-measuring?
  • If the medical device can be classified as a class I non-sterile and non-measuring, can it include a scale be included? The scale is not essential for its intended clinical use and potentially unlikely to be of any benefit for the users of the device.

Also, I understand that class I sterile can take months to obtain and can be expensive. It requires a full QMS assessment by a notified body, is this correct?

Can you advice on the above and also help with obtaining CE? If there are any consultants out there who can help, I would be interest to discuss this in further detail

regards
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello Pureason and welcome to the Cove :bigwave:

If the medical device can be classified as class I non-sterile and non-measuring, can the product be sterilised to ensure it is clinically clean for used but not labelled as sterile or is sterilisation not permitted if the product is CE marked as class I non-sterile and non-measuring?
If there's a clinical need to ensure that the syringe is clean, and it will consequently be sterilised as part of its original manufacture, I think that not labelling it as sterile would not matter (at best). If sterilisation is necessary then proper controls must be in place, and this is what the NB is supposed to check when auditing class I sterile devices. If you classify your device as class I NMNS and self-certify, while at the same time deeeming sterilisation necessary and sterilising the device during its original manufacture, you are circumventing this oversight.

If the medical device can be classified as a class I non-sterile and non-measuring, can it include a scale be included? The scale is not essential for its intended clinical use and potentially unlikely to be of any benefit for the users of the device.
If the intended use, as well as the device's IFU you issue, don't include any use of that scale (e.g. it's there just because it's part of the OEM's existing design) then I would say that that device can be considered non-measuring. To be on the safe side, I would add a warning in the IFU that the scale should not be used or relied upon in any way.

Also, I understand that class I sterile can take months to obtain and can be expensive. It requires a full QMS assessment by a notified body, is this correct?
Partly correct. The Notified Body is only supposed to assess aspects of manufacture that relate to sterility; not the whole QMS.

Can you advice on the above and also help with obtaining CE? If there are any consultants out there who can help, I would be interest to discuss this in further detail
Please feel welcome to send me a private message and we can take it from there.

Cheers,
Ronen.
 
Last edited:
P

Pureason

#3
Your reply is appreciated Ronen.

As a new user, I am unable to send you a PM. Can you drop me your email?
 

dgrainger

Trusted Information Resource
#5
Hi,

You will need to check the requirements given by the manufacturer of any medicine intended to be injected (ER 7.3).
If there are DOSAGE AND ADMINISTRATION requirements then you may require a measurement function.
 
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