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ce mark and ce marking, class ii medical device, exports and exporting, mdd (medical device directive), medical device listing codes and classifications, medical devices (general)
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Old 8th June 2004, 09:52 PM
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Question What is the process of getting a CE Mark?

Hi everybody, I have been following this cove for sometimes and was very amazed by the reply given by all the specialist in the forum. I am kinda new in Medical Devices industry, and would like to seek help from all of you. My company plan to import our products to EU (Class IIa products in MDD classification). I understand that in order to export to EU, we need to apply for CE mark. Can anyone kindly brief me how long do we need to take for CE mark application and how is the process of getting it? Beside getting CE mark, do we need any other market clearance for exporting to EU?

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Old 8th June 2004, 10:19 PM
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Quote:
In Reply to Parent Post by Hello

Hi everybody, I have been following this cove for sometimes and was very amazed by the reply given by all the specialist in the forum. I am kinda new in Medical Devices industry, and would like to seek help from all of you. My company plan to import our products to EU (Class IIa products in MDD classification). I understand that in order to export to EU, we need to apply for CE mark. Can anyone kindly brief me how long do we need to take for CE mark application and how is the process of getting it? Beside getting CE mark, do we need any other market clearance for exporting to EU?
The time it takes depends on what Annex you use. If you are going with the MDD Annex II, Full Quality Assurance, you will need:
  1. Select a Notified Body experienced with your type of device
  2. Become registered to ISO 13485.
  3. Develop a Technical File
Take a look at these threads
http://elsmar.com/Forums/showthread.php?t=8498
http://elsmar.com/Forums/showthread.php?t=8658

Just the MDD.

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Old 11th June 2004, 01:39 AM
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Thanks Al.

We are going to be audited for our ISO 13485:2003 next month. Do we need to select the same NB for CE mark and ISO 13485:2003?

Do you have any idea how long will it takes after we submit our technical file to them in order to acquire the CE mark?
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Old 11th June 2004, 11:52 AM
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Quote:
In Reply to Parent Post by Hello

Thanks Al.

We are going to be audited for our ISO 13485:2003 next month. Do we need to select the same NB for CE mark and ISO 13485:2003?

Do you have any idea how long will it takes after we submit our technical file to them in order to acquire the CE mark?
Yes it will be the same body, since they will review your technical file periodically. Ours does the TF review during our QMS audits. Ask them how long it will take to review your TF and issue the certificate.

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Old 11th June 2004, 05:33 PM
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Technical File Review

Our initial ISO audit was done in Fall 2002. The one Technical File our NB needed to review and approve was not ready at that time. Only one of our products is Annex IIb. The rest are Self-Declaring. We sent it to them when it was ready and it took 1 month for their review and reply. But, that was near the big push for December 7th 2003. They were really backed up at that time. It all depends on the type of product, the amount of data included in the the file and the work load of your NB.
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Old 14th June 2004, 09:54 AM
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There is no explicit need to have the same CB for ISO 13485- and MDD- certification, but it makes sense.

There is also no explicit need to have a 13485 certificate for compliance acc. the MDD (but audits would take more time, if there is no assumption of conformity acc. 13485...).

It makes sense to use the same NB for both the MDD and ISO 13485, because you can make a combined audit which costs less time and money.
(I know companies, which have one CB for 9001, one for 13485 and a NB for MDD...)

The best way for striving a "notified" CE-mark is:

a) be sure wchich class your device is
b) choose thed Annex of MDD (Annex II, V or VI plus II or VII)
c) establish a QM system (EN 13485 helps a lot)
d) complete your technical file
e) get certified

You should contact your notified body of trust as soon as possible to discuss the path of certification and some other details.

The time required for the whole certification procedure depends primarily on the ammount of different products to be certified, the number of employees in production and the chosen annex (and at last but not least on the NB

If there were no adverse events it might be possible to close a file within one month (if everything is prepared and perfect also 2 Weeks are impossible - but doable [but thats the extraordinary exception, not common practice])

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Old 15th June 2004, 10:29 PM
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Thanks guys, your information has given me a clearer picture. Well, shall I say that after our CE application has been certified, we can sell freely in EU market?
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Old 17th June 2004, 10:01 AM
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I have written down a "Medical Device CE-Lifecycle" acc. to the MDD and attached the document.

There you can find the important steps for CE-marking of medical devices.

Note that a CE-marked device is never an "fly and forget" issue. Either the manufacturer is under surveillance by a notified body, or by the competent authority (they are setting up teams for this job at the moment).

Periodically management of the technical documentation and the risk management file will be a hot topic as well as the "post market surveillance" (Article 10 of MDD).

And a last thing: manufacturers outside the EC need an "‘authorised representative" within the EC.

HTH-HAND
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