MDD class IIa Annex V or VI: specific doubts when implented

[SUZANNE_Manager]

Medical Device Directive - Annex VI assessment

I´m glad

to find a place where i could exchange ideas and doubts about CE marking of medical devices.

I read the MDD 93/42/EEC, the ISO 13485 and I have asked a notified body. but I still have many doubts.

the case is the following:

- medical device class IIa
- contract manufacturer with ISO 9002 or ISO 13485
- we have not a QMS certified
- we have been recommended to follow Annex V or VI of the MDD.

our doubts are:

1) if our contract manufacturer, who gives us the final product, has ISO 9002 or ISO 13485, should we certified ISO 13485 for any of our company´s activities (testing and final verification, dispatch, complain, etc)? because we read that it´s not compulsory but the notified body opinion is the opposite.

2) should the contract manufacturer´s suppliers have ISO 9002 or 13485?


3) and in the case we want to sell a product which has been manufactured under ISO 9002 or ISO 13485, but which has no CE mark. what should we ask for to the manufacturer? as importers, should we certify our activities?

I would be very pleased if someone could help me!!!

 

[Al Rosen]

I´M GLAD TO FIND A PLACE WHERE I COULD EXCHANGE IDEAS AND DOUBTS ABOUT CE MARKING OF MEDICAL DEVICES.
I READ THE MDD 93/42/EEC, THE ISO 13485 AND I HAVE ASKED A NOTIFIED BODY. BUT I STILL HAVE MANY DOUBTS.

THE CASE IS THE FOLLOWING:

- MEDICAL DEVICE CLASS IIa
- CONTRACT MANUFACTURER WITH ISO 9002 OR ISO 13485
- WE HAVE NOT A QMS CERTIFIED
- WE HAVE BEEN RECOMMENDED TO FOLLOW ANNEX V OR VI OF THE MDD.

OUR DOUBTS ARE:

1) IF OUR CONTRACT MANUFACTURER, WHO GIVES US THE FINAL PRODUCT, HAS ISO 9002 OR ISO 13485, SHOULD WE CERTIFIED ISO 13485 FOR ANY OF OUR COMPANY´S ACTIVITIES (TESTING AND FINAL VERIFICATION, DISPATCH, COMPLAIN,ETC)? BECAUSE WE READ THAT IT´S NOT COMPULSORY BUT THE NOTIFIED BODY OPINION IS THE OPPOSITE.

2) SHOULD THE CONTRACT MANUFACTURER´S SUPPLIERS HAVE ISO 9002 OR 13485?


3) AND IN THE CASE WE WANT TO SELL A PRODUCT WHICH HAS BEEN MANUFACTURED UNDER ISO 9002 OR ISO 13485, BUT WHICH HAS NO CE MARK. WHAT SHOULD WE ASK FOR TO THE MANUFACTURER? AS IMPORTERS, SHOULD WE CERTIFY OUR ACTIVITIES?

I WOULD BE VERY PLEASED IF SOMEONE COULD HELP ME!!!

Welcome to the Cove. Please turn off your caps. No need to shout here.

1. ISO 9002 does not exist, so this is not an option. It is replaced by ISO 9001:2000. I tend to agree with your notified body. Since you are placing the device on the market, you shouldt have theISO 13485 QMS. Where did you read that it was not compulsory? Please reference the official document, The Medical Device Directive (MDD), article and section.
2. It depends. Without knowledge of the details of your and your supplier's operation, the question can not be answered. There is no requirement for your suppliers in general to be registered to any QMS, but the extent of the controls required is dependent on the effect of the purchased product on the final device. If you are buying a completed device and only putting your label on it, your supplier needs to be registered to some QMS and since you are placing it on the market, you need to be registered ISO 13485.
3. You cannot legaly place the device on the market without the CE mark. So if you import a device from a "supplier", you must have a quality system that meets the requirements of the MDD. ISO 13485 is standard that is recognized as such. It addresses what you will have to do to control your suppliers in section 7.4.

I general your notified body will dictate what you will have to do to meet the requirements. If you are still in doubt, speak to another NB.

 

[wrodnigg]

Dear Suzanne,

the decision which Annex one should follow primarily depends on the product you want to sell.

Do you just want to sell one product, or are you planning to sell differen products? If you just have one, Annex IV would be another possibility.

As a "manufacturer" (the responsible organisation, which sells the device within the EU) you have to fulfill at least some kind of quality management system in order to facilitate traceability of your devices from the ressources to the customers. If you use sub contractors, you are still responsible for this task. And you are also responsible for a vigilance and adverse event reporting process.

If your sub contractor does quality relevant preocessing on your device, you are responsible to ensure, that he enables capable processes. A notified body will accept a 13485 certificate from another notified body, otherwise he will do an audit at the production site of your sub. As al wrote, there aren't any valid 9002 certificates left in our world.

As competent authorities are setting up their task forces for market surveillance, you are strongly recommended NOT to sell any medical device wich is not compliant with the MDD.

As I wrote above, responsible for CE marking is the organization, which is placing the device on the european market: either the manufacturer or the importeur.

(just from an other NB)

 

[SUZANNE_Manager]

Many thanks for all your advices!


Regarding your opinion about taking the ANNEX IV of the MDD, we think that following route IV is not affordable for us, because we understand that in that case, a notified body will ask to test each device, what means an expensive route.
You asked how many devices are we planning to certify. The intention is the certification of only one product (a class IIa).
Are we right?
It is not clear for us if we would have to test EVERY device!!!, or some units of EACH batch manufactured (let's say 200 per year). A consultant told us all the units would have to be tested.


I would appreciate if some of you could analyze and comment the following 2 cases we present.

Assumptions for the cases presented hereafter:
The device will be built by the following companies (based on our design)

- company A which will build the printed circuit board and solder the electronic components on it
- company B which will be the supplier of the display of the device
- company C which will be the supplier of the case (container)
- company D which will be the supplier of the medical grade power supply certified under the 60601-1 and derivatives
- (Only applicable in case 2) company E will manufacture the equipment and will deliver the finished equipment to us.


The cases are:

case 1) OUR COMPANY will be the assembler of the equipment and will perform the final tests.

In this case:

1.1) Having the QMS certified would be an advantage. In case we decide to certify our company under ISO13485, whether

through ANNEX V or ANNEX VI, which activities of our company have to be certified? We understand we are the manufacturers

in this case. Is it possible to certify only the final inspection and testing? We think the NB could also audit our

assembling process randomly according to the MDD.
1.2) what kind of requirements should we ask to our suppliers in order to have a quality control of our product?
1.3) In case the company "A" has a certified QMS, What kind of requirements would they ask us to fill refering to electronic components chosen for our design?
1.4) What if suppliers of specifics components do not have certification or a QMS? Could we choose them, anyway? Will company "A" accept them? There are companies that design very specific and unic chips and have contract manufacturers for the chip manufacturing, normally in Asia, wihtout having a QMS themselves. How could us guarantee the quality of their components and hence our product? Should we?

case 2) A CONTRACT MANUFACTURER give us the final product and OUR COMPANY perform the final tests.

2.1) Should our contract manufacturer be ISO13485 certified if we want to certify our company under ISO13485 taking ANNEX VI?
2.2) Will our NB audits take place at our contract manufacturer's premises? Does this depend on the ANNEX chosen?
2.3) Must our QMS include the contract manufacturer's proceedings or it's enough by showing their QMS certificates?
2.4) What kind of requirements should we be asked by the contract manufacturer refering to the chosen electronic components, displays, encloser, etc?
Should the suppliers have a QMS in order to be able to provide components to a ISO13485 contract manufacturer? In that case, we would have to modify the design!!!!
2.5) Should we certify the final inspection and testing, and the rest of our company's activities or at least implement a QMS over them?


Thanks for all the help you could give us!!!



Suzanne

 

[Al Rosen]

Many thanks for all your advices!


Regarding your opinion about taking the ANNEX IV of the MDD, we think that following route IV is not affordable for us, because we understand that in that case, a notified body will ask to test each device, what means an expensive route.
You asked how many devices are we planning to certify. The intention is the certification of only one product (a class IIa).
Are we right?
It is not clear for us if we would have to test EVERY device!!!, or some units of EACH batch manufactured (let's say 200 per year). A consultant told us all the units would have to be tested.


I would appreciate if some of you could analyze and comment the following 2 cases we present.

Assumptions for the cases presented hereafter:
The device will be built by the following companies (based on our design)

- company A which will build the printed circuit board and solder the electronic components on it
- company B which will be the supplier of the display of the device
- company C which will be the supplier of the case (container)
- company D which will be the supplier of the medical grade power supply certified under the 60601-1 and derivatives
- (Only applicable in case 2) company E will manufacture the equipment and will deliver the finished equipment to us.


The cases are:

case 1) OUR COMPANY will be the assembler of the equipment and will perform the final tests.

In this case:

1.1) Having the QMS certified would be an advantage. In case we decide to certify our company under ISO13485, whether

through ANNEX V or ANNEX VI, which activities of our company have to be certified? We understand we are the manufacturers

in this case. Is it possible to certify only the final inspection and testing? We think the NB could also audit our

assembling process randomly according to the MDD.
1.2) what kind of requirements should we ask to our suppliers in order to have a quality control of our product?
1.3) In case the company "A" has a certified QMS, What kind of requirements would they ask us to fill refering to electronic components chosen for our design?
1.4) What if suppliers of specifics components do not have certification or a QMS? Could we choose them, anyway? Will company "A" accept them? There are companies that design very specific and unic chips and have contract manufacturers for the chip manufacturing, normally in Asia, wihtout having a QMS themselves. How could us guarantee the quality of their components and hence our product? Should we?

case 2) A CONTRACT MANUFACTURER give us the final product and OUR COMPANY perform the final tests.

2.1) Should our contract manufacturer be ISO13485 certified if we want to certify our company under ISO13485 taking ANNEX VI?
2.2) Will our NB audits take place at our contract manufacturer's premises? Does this depend on the ANNEX chosen?
2.3) Must our QMS include the contract manufacturer's proceedings or it's enough by showing their QMS certificates?
2.4) What kind of requirements should we be asked by the contract manufacturer refering to the chosen electronic components, displays, encloser, etc?
Should the suppliers have a QMS in order to be able to provide components to a ISO13485 contract manufacturer? In that case, we would have to modify the design!!!!
2.5) Should we certify the final inspection and testing, and the rest of our company's activities or at least implement a QMS over them?


Thanks for all the help you could give us!!!



Suzanne

Suzzane:

• Who's design is this and who controls it?

• A, B, C & D are suppliers and don't neccesarily require registration to a quality system, but who & how are the suppliers going to be controlled (who verifies the supplied components & how are they verified as acceptable)? Someone needs to do this.

It seems to me that the questions you pose are better answered by your Notified Body.

1. You cannot get around having a Quality System.
2. You have to control your suppliers.
3. You have to control your Contract Manufacturer.

The extent of controls will vary due to the complexity and criticality of the processes.

If you have spoken to a NB and are not convinced that you will have to do these things, contact another NB and verify it.



You may find the following sites helpful
MDQ Consultancy

Walkang Tech Consulting

 

[SUZANNE_Manager]

Device´s language/user manual´s language

Hello!
As usual, I have always received excellent advice from you! Thank U!
And I hope, this time won´t be an exception...
Now... I have some doubts about my device (a class IIa)...
Should the device come in the language of each country it is planned to be sold? or is it enough to have only the user manual in each language?
Thanks a lot!!!
Suzzane

 

[Al Rosen]

Hello!
As usual, I have always received excellent advice from you! Thank U!
And I hope, this time won´t be an exception...
Now... I have some doubts about my device (a class IIa)...
Should the device come in the language of each country it is planned to be sold? or is it enough to have only the user manual in each language?
Thanks a lot!!!
Suzzane

I believe it is everything in Annex I #13. The language requirements are up to the individual countries. The subject was also discussed in this thread.