Conformity Assessment required for Self-Cert?

[Lupop77]

Hi all, does anyone have any knowledge of the need for a Conformity Assessment if manufacturing a standard Class I Medical Device under the rules for MDR?

I am aware that Class I devices that are sterile or have a measuring function will require NB approval however if we are self certing a device, do we still have to undergo a Conformity Assessment by our NB to have the CE mark approved? Is a CE conformity assessment for a Class I required or can the CE marking of the device also be self certified?

I'm finding conflicting information, some pages are stating that the conformity assessment is required and can be done alongside a 13485 audit, while other sites are claiming that self certified CE is perfectly acceptable if it meets the requirements for being self cert.

TIA

 

[Sidney Vianna]

self certified

there is no such thing. There is self declaration of conformity.

 

[Lupop77]

Sorry, in my haste I typed self cert but I was referring to self declaration of conformity; is a CE conformity assessment required in this instance?

I'm being asked for a EC CE Certificate for self declared conformity on a class I device and I cannot find clear guidance on whether this is actually required.

 

[Nichole F]

For a class I, non-sterile, non-measuring, non-reusable surgical device, self-certification is the assessment pathway under MDR. There is no notified body involvement. You still need to fulfill the requirements of MDR (declaration of conformity, technical documentation, EC-REP if needed, etc.) but no external party assesses these documents aside from other economic operators or competent authorities if they documents are ever needing to be sent to them. No CE certificate is issued as there is no notified body to issue it. Along the same lines, your CE mark on your device will not have an NB number with it. Essentially your DoC is your CE certificate.

 

[Lupop77]

For a class I, non-sterile, non-measuring, non-reusable surgical device, self-certification is the assessment pathway under MDR. There is no notified body involvement. You still need to fulfill the requirements of MDR (declaration of conformity, technical documentation, EC-REP if needed, etc.) but no external party assesses these documents aside from other economic operators or competent authorities if they documents are ever needing to be sent to them. No CE certificate is issued as there is no notified body to issue it. Along the same lines, your CE mark on your device will not have an NB number with it. Essentially your DoC is your CE certificate.

Thank you so much!