Documents necessary for registration of a Medical Device

Hello.

I hope that someone can help me with this issue.

We manufacture one dental gel which is present (almost 3 years) in 2 EU countries and there it is classified as a cosmetic product - toothpaste.

From June 2013 on the whole EU territory will be active new cosmetic registration centralized procedure.

Now, we want to register our gel as a medical device (class 1 or class 2A).

Because we posses only ISO 9001 certificate for producing of high functional toothpaste and we are located in Korea for a declaration of our conformity
if we choose a registration in a class 1 we need to:

* prepare Technical file preparation for CA Notification
* Notification of Class I Medical Devices to EUDAMED
* and we need to have own Representative on the whole EU.

Please, could You tell me, which documents we need to posses for preparation of the technical file ?

(we have MSDS for all ingredients, IFRA conformity, Patch tests results. Challenged test results, own instruction manual on a English, Device Description and labeling and packaging review, Clinical Data (Fotos and description from our cases)).

I know that if we choose a registration the group Class 2 A, this declaration must be backed up in all cases with conformity assessment by Notified Body. and then this assessment may, at the manufacturer?s choice, can be completed via an examination and testing of each product or homogeneous batch of products (Annex IV). Probably and then we need to posses similar documents.

Thanks in advanced and Kindest regards from me,

Deny

Technical File requirements for medical devices is attached.

Now, we want to register our gel as a medical device (class 1 or class 2A).

Click to expand...

Please note:Your classification for any medical device shall be based on the requirements of the applicable Directive, supported by a rationale.

Thank You very much Joanne.

I have another question. I hope that You or someone on the net will have time to answer me.

I mentioned before that until now our gel was registered in few EU countries as a cosmetic product (toothpaste).

Our intention now is the gel to be registered as a medical device (Class 1).

One of the ingredients in the dental gel is Chitosan.

I found something on the net - about a chitosan.

Chitin and its derivatives are derived from the animals.

According of the 17 th rule of MDD all medical devices
containing chitin or its derivatives are incorporated in
the III class.

stepitn.eu/wp-content/uploads/2011/03/PM_30_Lodz_Struszczyk.pdf

CRITICAL ASPECTS OF CHITINOUS DERIVATIVES USE
FOR DESIGN OF MEDICAL DEVICES

The most crucial aspects affecting the safety and performance of
medical device made of chitin and its derivatives its:
• purity (medical grade chitosan processes the chitin under
clean-room conditions in a series of verifiable purification
steps);
• re-productivity of chitin sources;
• absence of European Standards regulating directly requirements
for chitin and its derivatives in design of medical devices;
• compliance with the European Standards, e.g. EN ISO 22442-1/2/3
Standards;
• sterilization of medical devices containing chitin or its
derivatives – critical process may affected their biocompatibility

Chitosan is a linear polysaccharide composed of randomly distributed glucosamine. It is made by treating shrimp and other crustacean shells with the alkali sodium hydroxide.

In our gel the level of a chitosan is: 0.05 %

What is Your opinion ?

Is there any chance the gel to be registered in the EU in the class 1 taking in to consideration: the content of the gel (chitosan), our previous registration as a toothpaste, the presence of the gel from 2008 year, no one unwanted registered case and the excellent results from the Challenged test ?

Do You know for similar exceptions ?

Thanks in advanced