Article 12 MDD... Procedure packs! Requirements to Repack already CE Marked Products

[Bassman84]

Dear Forum Users,

I am new in a regulatory department for medical devices.

I have been given responsibility to look into the requirements to repack already CE marked products for incorporation to a medical system that we are developing.

I see that the limitation is "within their intended purpose" and "limits of use specified by their manufacturers". It is therefore not possible to separate components of a CE marked system i.e. is it possible to add a syringe to a capillary filling device and consider this as CE in the new form?

Sorry if this is a basic problem to the experienced among us...

Thanks!

 

[Stijloor]

Re: Article 12 MDD... Procedure packs! Requirements to Repack already CE Marked Produ

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.

 

[Stijloor]

Re: Article 12 MDD... Procedure packs! Requirements to Repack already CE Marked Produ

One more Quick Bump!

Can someone help with this?

Thank you very much!!

Stijloor.

 

[MIREGMGR]

Re: Article 12 MDD... Procedure packs! Requirements to Repack already CE Marked Produ

I see that the limitation is "within their intended purpose" and "limits of use specified by their manufacturers". It is therefore not possible to separate components of a CE marked system i.e. is it possible to add a syringe to a capillary filling device and consider this as CE in the new form?

I'm sorry, but I don't understand the explanation. Please re-word, or check for missing words, or offer an example.

 

[Jerome]

Re: Article 12 MDD... Procedure packs! Requirements to Repack already CE Marked Produ

I'm not quite sure what you are looking for.
First you say you repack a medical device, but you then want to incorporate it in another device?
quote: ...to repack already CE marked products for incorporation to a medical system...

What is the purpose of repackaging the initial medical device then?
If this is to remove the initial brand, then look for guidance on re-branding of medical devices. (assuming it is produced and certified by another company)
If it is because you use it as an integral part of your new Medical Device, you'll need to re-evaluate it in the perspective of the whole (new) device.

Please elaborate what you are trying to establish.
Other questions that come to mind are:
- Is (or will be) your newly designed system a Medical device?
- if so what class?
- Do you change the intended purpose of the 'earlier certified' medical device?
- What class is that?
- Why do you repack?
- Is the (to be) repacked device certified by you or is it bought in from another company.

I get the feeling you are trying to avoid (new) certification activities by using certified components in a new device, right?