Julie Omohundro Tautvydas, different regulatory jurisdictions have different classification schemes. Are you talking about EU (MDD or MDR?) or some other jurisdiction?

Does the glue (even when partly) stay IN the body. Than its mostlikely 3

Tautvydas Kazlauskas Thank you kindly for replying.
Julie O. im interested in CE mark certification in EU.
Marc Schoenmakers Yes, it does. I also thought that it should be 3, but since there are no strict boundries between IIb & III, i wanted to make sure.
Also, don't know how true its is, but i've heard that it can even depend on specific Notified Body, some would agree with IIb, others - only with III.

You need certified/qualified regulatory advice to be 100% sure, but i believe it will be IIb, as long as all the 'product' is absorbed and completely removes itself over a period of time from the body. If it's a permanent, which is highly unlikely, it would be a III.

You require the product to be sterile before use. That makes it class 3

Barry Fitch Key to understand whether MDD or MDr. You will need to fully document your rationale and and consider all rules against the intended purpose and consider the materials. All NBs will want to see how you arrived at the classification. Agree that if remains and is wholly absorbed is likely to be Class III

I agree with Marc, if glue residual in body then EU 3

Cuitlahuac Velazquez If you're not sure, you can use the keyword directory in the PRODUCT CODE CLASSIFICATION DATABASE. In most cases this database will identify the classification regulation in the CFR.

You will need to identify the intended use, the whether or not it is sterile, if it will be used in conjunction with another device (e.g. combo product) and which global regulatory agency you need to comply with.

To start with, you can try the FDA Product Code Builder which will help get you headed in the right direction. https://www.accessdata.fda.gov/scripts/ora/pcb/index.cfm

Michael Tar

Since you seem to be asking about classification in Europe, I would refer you to my colleague Adrian Keene. He’s on LinkedIn or you can email him at akeene@namsa.com.

. Biom’Up’s Hemoblast Bellows is a Class III device so yours is probably also Class III.

Robert Packard

There is a guidance document for the EU device classification that should be used: MEDDEV 2.4/1 rev 9. Here’s a hyperlink: http://ec.europa.eu/DocsRoom/documents/10337/attachments/1/translations/en/renditions/native
In addition, I think it’s worth noting that Barry Fitch was Head of the Intertek Notified Body–certainly a qualified regulatory expert.
The answer to the question for EU is Class III. The explanation is provided on page 20 of the guidance document. The applicable rule is 8, indent #3. The short rationale is that the product is absorbed by the body–even if not completely. Sterility is not the determining factor.
When you are writing a classification rationale, you need to write an explanation for why each rule applies or does not apply. You should actually start with the Special Rules, because they will “trump” other rules. For example, blood bags will be Class IIb according to Rule 18.
Ultimately, your company and the NB must agree. But NB’s sometimes need to be persuaded when they take too conservative of a classification position. I have successfully reclassified several products from Class III to Class IIb over the years, but this is not one you can classify as IIb.
Rob Packard
https://medicaldeviceacademy.com
rob@13485cert.com