Contract Manufacturer EC Certificate Scope

Nash27

Involved In Discussions
#1
We are using a contract manufacturer to manufacture some of our products, these products are TGA class IIa non sterile products (nebuliser and mask). Our contract manufacturer have CE marking and EC certificate to manufacture mask but they do not have EC certificate to manufacture nebuliser as they exclusively manufacture for us and their local market (different design) that does not require CE marking requirement.

We have conformity assessment certificate from our notified body to manufacture nebuliser and mask. Contract manufacturer supply some finished product that we simply re-distribute and some bulk-finished product we do the packaging.

My question is;

Whether its necessary for the contract manufacturer to have their nebuliser included under their EC certificate or they do not necessarily need to include nebuliser in their EC certificate considering we are taking whole responsibility of the manufacturing.

Thanks
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
We are using a contract manufacturer to manufacture some of our products, these products are TGA class IIa non sterile products (nebuliser and mask). Our contract manufacturer have CE marking and EC certificate to manufacture mask but they do not have EC certificate to manufacture nebuliser as they exclusively manufacture for us and their local market (different design) that does not require CE marking requirement.

We have conformity assessment certificate from our notified body to manufacture nebuliser and mask. Contract manufacturer supply some finished product that we simply re-distribute and some bulk-finished product we do the packaging.

My question is;

Whether its necessary for the contract manufacturer to have their nebuliser included under their EC certificate or they do not necessarily need to include nebuliser in their EC certificate considering we are taking whole responsibility of the manufacturing.

Thanks
They do not necessarily need to include the nebuliser in their EC certificate considering you are taking whole responsibility of the manufacturing.

Their EC certificate only needs to cover devices they are placing on the EC market.

Cheers,
Ronen.
 
Last edited:

somashekar

Staff member
Super Moderator
#3
We have conformity assessment certificate from our notified body to manufacture nebuliser and mask. Contract manufacturer supply some finished product that we simply re-distribute and some bulk-finished product we do the packaging.
Just asking you if your contract manufacturer has an ISO 13485 and his scope includes manufacture of nebuliser and mask.
 

Nash27

Involved In Discussions
#4
Thanks Ronen, I thought this is right approach.

Specifc to your question Somshekhar;

Please see below their 13485 scope

"Production and Supply of Medical Devices and Components for Infusion Therapy, Transfusion Therapy, Gastroenterology, Urology, Anaesthesia, Surgery, such as Disposable Syringes, Infusion Sets, Blood Transfusion Sets, Scalp Vein Sets, Catheters and Tubes, Urine Bags, Cord Clamps. Production and Supply of Disposables, Hospital Supplies and Surgical Supplies/Products."

Their EC certificate refer to the oxygen and nebuliser mask but does not specify Nebuliser as an individual component.

Can you provide your comments please, Somshekhar!

Thanks
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Thanks Ronen, I thought this is right approach.

Specifc to your question Somshekhar;

Please see below their 13485 scope

"Production and Supply of Medical Devices and Components for Infusion Therapy, Transfusion Therapy, Gastroenterology, Urology, Anaesthesia, Surgery, such as Disposable Syringes, Infusion Sets, Blood Transfusion Sets, Scalp Vein Sets, Catheters and Tubes, Urine Bags, Cord Clamps. Production and Supply of Disposables, Hospital Supplies and Surgical Supplies/Products."

Their EC certificate refer to the oxygen and nebuliser mask but does not specify Nebuliser as an individual component.

Can you provide your comments please, Somshekhar!

Thanks
This might be a little alarming, actually. It seems that designing and making devices such as neubilisers is not exactly in their core business; at least as far as their ISO 13485 coverage is concerned.

Ronen.
 

somashekar

Staff member
Super Moderator
#6
This might be a little alarming, actually. It seems that designing and making devices such as neubilisers is not exactly in their core business; at least as far as their ISO 13485 coverage is concerned.

Ronen.
I was coming to that. Nebuliser is an electromechanical medical device. All the examples in your CM's ISO13485 does not indicate they have a QMS established for your type of medical device requirement. This is the question about selection of your CM for manufacturing your devices.
 

Nash27

Involved In Discussions
#7
Thanks Ronen and Somashekar,

Nebuliser itself is a non-active medical device it can operate when connected through a suitable source of air or compressor. We supply them as individually packed or as part of the nebuliser set. Nebuliser designed by us along with supply of required tool. So technically we are taking whole responsibility of the manufacturing.

The contract manufacturer (CM) is ISO 13485: 2003 certified manufacturing company, manufacturing sterile and non-sterile class IIa devices. The CM is approved by TGA on our conformity assessment certificate approved supplier list. In current scenario we are supplying nebuliser as non-sterile product. What objections can anyone would have?
 

somashekar

Staff member
Super Moderator
#8
Thanks for the clarification Nash. So here the Nebuliser is an assembly of 4 precision plastic injection molded parts. Am I right ?
These are within the capability of your CM. When you demonstrate that you exercise adequate controls on your CM and he has capability for manufacturing such parts which assemble to a Nebuliser, you are perhaps OK.
Your CM can suitably include this into his QMS certification scope as well. Adds value to both of you.
 

Nash27

Involved In Discussions
#9
Yes Somshekar, you are right. I already requested them to include nebuliser in their scope, I reckon I need to be more persistent/pushy with this request.

Thanks for your time.
 
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