CE Mark - FDA - Class I traction systems - What is involved and how long does it take

[LGDeneault]

Hello All!

The company that I work for manufactures FDA - Class I traction systems for the lower back and neck. We would like to put the CE Mark on these systems but I don't know what is required or how long this all will take. Have any thoughts...

Best Regards,

LEE

 

[Claes Gefvenberg]

We would like to put the CE Mark on these systems but I don't know what is required or how long this all will take.

Hello Lee,

I suggest a look at this link for starters: https://www.ce-marking.org/index.html, and hope that other more savvy Cove dwellers can add further info if necessary.

/Claes

 

[Downey White]

In the past I found much useful to gather some general information

https://www.ce-mark.com

Hope can give you some hints.

 

[CarolX]

Lee-

I moved your thread to a more appropriate board.

Please scroll down to the bottom of the page for links to similar threads. You may find more info in those threads.

 

[Al Rosen]

Hello All!

The company that I work for manufactures FDA - Class I traction systems for the lower back and neck. We would like to put the CE Mark on these systems but I don't know what is required or how long this all will take. Have any thoughts...

Best Regards,

LEE

Lee:

1. Using the Medical Device Directive(MDD) Annex IX, verify that the device is class I.
2. Detemine the Annex (probably VII) you will use to enter the market. Annex VII is self certification and can only be used for Class I devices.
3. You will then need to comply with the Essential requirements in Annex I and establish a Technical File and comply with the requirements outlined in Annex VII.
4. Sign a declaration of Conformity and CE mark the device.

I have attached a copy of the MDD.


I would say it can be done in 1-6 months since it is a self certification(does not require a notified body) and depends on how much data you have to meet the essential requirements and TF.

 

[LGDeneault]

CE Mark...?

Thanks EVERYONE!

I truly am grateful for ALL of your help!



Best Regards,

LEE