Length of validity of a self certified Declaration of Conformity (DoC) for CE mark
- Thread starter rob73
- Start date
F
FredLaBosche
Re: Length of validity of DoC
We usually align the DoC valdity Length to the product or 13485 certificate.
We usually align the DoC valdity Length to the product or 13485 certificate.
S
SteveK
Re: Length of validity of a self certified Declaration of Conformity (DoC) for CE mar
Hi Rob,
We just have:
Declaration of Conformity
We ACME Ltd hereby declare that all devices on the attached schedule conform to the appropriate requirements of the Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC.
We further declare that ABC is appointed as our Notified Body to undertake the provision of Annex II of the Directive.
This on our letterhead and is signed and dated (with a list of our products and Class ref etc). The footer of the document references ISO 13485 (e.g. as referrenced previously), Issue Number etc. Never had any issue about how long it should be valid for from our NB.
Steve
Hello all,
I seem to remember a thread about how long a self certified Declaration of Conformity (CE) should be valid for, but cannot find it! Can any one point me in the right direction?
Rob
Hi Rob,
We just have:
Declaration of Conformity
We ACME Ltd hereby declare that all devices on the attached schedule conform to the appropriate requirements of the Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC.
We further declare that ABC is appointed as our Notified Body to undertake the provision of Annex II of the Directive.
This on our letterhead and is signed and dated (with a list of our products and Class ref etc). The footer of the document references ISO 13485 (e.g. as referrenced previously), Issue Number etc. Never had any issue about how long it should be valid for from our NB.
Steve
Re: Length of validity of a self certified Declaration of Conformity (DoC) for CE mar
I also remember something like this, but also cannot find it. The only ones I managede to find are the discussion involving an NB - which as a clear guidance for the validity.
I've just performed a quick google search and found nothing.
The only clear thing is that you need to register the device with the CA in the country of your AR (and some other countries too as they have requirements for self-certified).
I also remember something like this, but also cannot find it. The only ones I managede to find are the discussion involving an NB - which as a clear guidance for the validity.
I've just performed a quick google search and found nothing.
The only clear thing is that you need to register the device with the CA in the country of your AR (and some other countries too as they have requirements for self-certified).
Last edited:
Re: Length of validity of a self certified Declaration of Conformity (DoC) for CE mar
Could it be this: Declaration of Conformity for a Class III Medical Device Implant
Could it be this: Declaration of Conformity for a Class III Medical Device Implant
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