Who signs your Declaration of Conformity?

A

Adele

We are discussing who should be signing our DoC's. Currently, any of the Regulatory staff can do it. Our Notified Body has said they are surprised it isn't someone at senior management level. However, it was said informally and no finding came of it.

Does it specify in the MDD what level should be signing it? I am just familiar with it being an "authorised person".
 
R

Roland Cooke

I like to focus attention by suggesting "whoever's going to prison". :tg:
 
P

Piero

When I have this kind of doubts I look inside the "Blue Guide" of the European Commission ("Guide to the implementation of directives based on the New Approach and the Global Approach"). At para 5.4 they ask for the signature (or equivalent marking) of an Authorised Person.
In my company the EC declaration of conformity are signed by the Engineering Director who was authorised in written by the CEO. This was communicate by means of an Executive Announcement just to avoid that who ever could think to sign such a document. By that signature our Engineering Director takes responsibility for the company that all the Essential Safety Requirements were fulfilled.
 

Ajit Basrur

Leader
Admin
We are discussing who should be signing our DoC's. Currently, any of the Regulatory staff can do it. Our Notified Body has said they are surprised it isn't someone at senior management level. However, it was said informally and no finding came of it.

Does it specify in the MDD what level should be signing it? I am just familiar with it being an "authorised person".

Read this document for better clarification - http://www.conformance.info/kb/pdf/39.pdf
 
B

Bill Goss

A member of management should be signing the DoC, preferable someone with an awareness of what it is they are signing.

When I conduct audits I often ask employees why they sign (approve) certain documents and records and I often find they answer "Because I have always signed them" or "When I was hired the person in my position before me signed them". At that point I know I am on to something. What I am on to is that they really do not know from what angle they are reviewing and therefore approving the document or record. I then suspect that they merely sign these without actually adding any value in the process.

This is scary because there could be a valid reason for their review, to ensure something is correct. But if they are not seeing it that way, the documents and records they sign are being passed on without the necessary scrutiny that is required.

I hope this helps.

Bill Goss
 

Marc

Fully vaccinated are you?
Leader
Is there a difference between a Certificate of Conformance (c of c) and a Declaration of Conformity?
 

GStough

Leader
Super Moderator
Is there a difference between a Certificate of Conformance (c of c) and a Declaration of Conformity?

Yes. A Declaration of Conformity is required by the MDD. A Certificate of Conformance most often is a certificate that the product is in conformance with a specified set of requirements (21 CFR Part 820, customer requirements, established product specifications, etc. or whatever). This is usually requested by a customer and is specific to a production batch, lot, or work order/purchase order.

It is a much more serious thing to sign a Declaration of Conformity, IMO.
 
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Marc

Fully vaccinated are you?
Leader
Thanks for the clarification. I'm not MDD literate so I didn't know. I know what a C of C is. I don't know the distinction between an MDD required Declaration vs. a 'standard' Certificate.

Is the Declaration a government type of form or something like that?
 

GStough

Leader
Super Moderator
Thanks for the clarification. I'm not MDD literate so I didn't know. I know what a C of C is. I don't know the distinction between an MDD required Declaration vs. a 'standard' Certificate.

Is the Declaration a government type of form or something like that?

In order to have a medical device CE marked for marketing in Europe, a Declaration of Conformity is required by all the Member States of the European Union. So, in a nutshell, I guess you could say "yes", it's a "government thing". ;)
 
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