Regulatory Open Forum

 View Only
Rimsys 2024 RegEx AMA
Back to discussions
Expand all | Collapse all

Declaration of conformity sign off

  • 1.  Declaration of conformity sign off

    This message was posted by a user wishing to remain anonymous
    Posted 22-May-2020 12:21
    This message was posted by a user wishing to remain anonymous

    As the manufacturer's representative to sign off , we had the CEO to sign off on the DoC. However we are undergoing some organisational changes and are without a CEO currently. Do we have to re-issue the DoC with a new signatory , who can this be signatory ? or Can we continue to use the existing Doc if there are no device changes.


  • 2.  RE: Declaration of conformity sign off

    Posted 22-May-2020 19:09
    The existing DOC can be used if there no additional changes to the content of the DOC.

    ---------------------------------
    Shikha Malik
    Regulatory Affairs Specialist II

    Dallas TX
    United States
    ---------------------------------



    Original Message


  • 3.  RE: Declaration of conformity sign off

    Posted 24-May-2020 06:10
    Not necessarily Shikha, I do not particular agree with Declaration of Conformity (DofC) can still be used if no changes to content of the DofC.

    Keep in mind your DofC is the company's declaration the product complies with all requirements of the EU MDD or EU MDR.  I have seen companies issued non-conformities and I cite these as audit observations when the signature ... the person signing the Declaration of Conformity is no longer with the company or even sadly saw once the DofC was signed by a person who had not worked at the company for 2 years.  This has to be kept current because there needs to be the individual responsible for stating the product complies with safety and performance requirements as established in the Directive or Regulation.  It is also quite important under the EU MDR the Person Responsible for Regulatory Compliance ensures all product compliance is being met.

    The DofC is not like a 510(k) submission which is done once, or a validation report done once, this is a "living" document needing to be updated and maintained over the life of the product including any changes from lot to lot (if required).  The reality is the DofC is the declaration the company is making, with the responsible person making this declaration.  The EU MDR regulation says this, 'Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.' which if you refer back to Annex II, Annex IX, Article 15 there are expectations this signature is from a person responsible for compliance of the product and making said declaration.  How can the signature on the DofC be from a person who no longer works for the company?

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: Declaration of conformity sign off

    Posted 25-May-2020 01:31
    Hi Anon,

    I agree with Richard on that.
    If someone declares that the product conforms with the regulation (MDD or MDR), he must be accountable for that statement. How can he be accountable if he is not in the company anymore?
    And of course, it is not necessary the DoC to be signed by the CEO or the highest in hierarchy. As Richard mentioned, in the MDR it is possible to be signed by the Person for Regulatory Compliance.

    ------------------------------
    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
    ------------------------------

    Original Message


  • 5.  RE: Declaration of conformity sign off

    Posted 25-May-2020 13:34

    In this thread the CEO signed the DoC, but subsequently left the company. Does this require a new DoC? The answers offered are both:
    Yes, prepare a new DoC even if there are no changes in its content
    No, preparing a new DoC isn't required as long as there are no changes to its content

    I'm squarely in the No camp!

    The DoC is a record of the state of affairs of the device at the time of its approval.

    The principle seems to be that the current DoC is no longer valid since the person who signed it is no longer with the company. In other words, it is no longer a valid record.

    I don't know of a requirement in this area.

    Application of the principle has some significant consequences.

    I infer that the CEO has reviewed, approved, and signed the results of each Management Review. This is a record of the state of affairs of the QMS at the time of approval. I would next expect a view that these records are no longer valid and another person must sign them.

    Similarly, the principle suggests that each internal audit report requires a new signature when the auditor leaves the company.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 6.  RE: Declaration of conformity sign off

    Posted 26-May-2020 05:29
    I agree with  Dan on this one.  If nothing changed affecting  the DoC, it does not make sense to re-create it only if the person signing it changed. It is a record.

    However, many regulations change constantly  in EU.

    I would suggest you consider including in your procedures a periodic review that the statements on the DoC are still valid.  For example, this would apply if you make a statement  of compliance  with all relevant  laws, regulations  and Directives,  especially if you have them listed on the DoC. Revise and resign the DoC if necessary. This would  also be necessary  if the product models, or accessories etc. listed on the DoC change.

    I like having the PRRC sign.

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 7.  RE: Declaration of conformity sign off

    Posted 27-May-2020 04:06
    It might be perceived as an administrative burden but eventually the DoC is a legally binding document. Therefore, I'd expect the person signing off on behalf of the manufacturer, is an "authentic" company employee and not a phantom.

    ------------------------------
    Shirley Kadouri
    Tolochenaz
    Switzerland
    ------------------------------

    Original Message


  • 8.  RE: Declaration of conformity sign off

    Posted 27-May-2020 09:04
    Hi folks.

    There is always the intermediate position between the two polar extreme options (use current document or recreate said document for new signature).  You could simply put together an addendum to your DoC that states that the declaration remains accurate and that the product continues to meet the specifics of the statement which could be signed by the current signatory.  I agree, I like the PRRC being the signatory on such statements because that is, after all, the responsibility that they have accepted by their acceptance of the role.

    ------------------------------
    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
    ------------------------------

    Original Message


  • 9.  RE: Declaration of conformity sign off

    This message was posted by a user wishing to remain anonymous
    Posted 26-May-2020 08:52
    This message was posted by a user wishing to remain anonymous

    You should be fine using the old DoC if Essential Requirements are not impacted. If your procedure doesn't dictate the alternate option, an internal memo shall suffice the need.
    Original Message


  • 10.  RE: Declaration of conformity sign off

    Posted 31-May-2020 15:39
    I also agree with Richard et al; the DoC needs to be re-signed.

    Here's why:
    A DoC is a legal document; and whoever signs it, takes responsibility on-behalf of the legal manufacturer, that the device in question is compliant against the quoted regulation. Additionally, the DoC must be valid on the day the device is being placed within the EU market. If you place the product today, the DoC must be valid today. If the CEO no longer represents the manufacturer (and manufacturer has not officially designate that person to act on their behalf), then the DoC technically becomes invalid on the day CEO leaves the company. I'm not suggesting that your product is all of a sudden unsafe and not compliant anymore; however, in a court of law; that document (DoC) will not hold value. Therefore for your own insurance policy, you need the DoC to be re-signed by someone who can legally represents the manufacturer on the day.    

    I have been a NB auditor/Technical File reviewer for more than a decade and if I observe this situation during an audit, it'll be a non-conformance (most likely Major NC) in most circumstances (unless the I'm auditing the same day/week CEO left the company).

    Hope it helps.

    ------------------------------
    Salman Raza
    Technical Manager - Medical Devices
    Richmond TX
    United States
    ------------------------------

    Original Message


  • 11.  RE: Declaration of conformity sign off

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jun-2020 08:27
    This message was posted by a user wishing to remain anonymous

    It is an interesting discussion and thank you for all. 

    I personally feel the re-signing is strange. 
    For example, if the signer of a contract would leave the company, would the contract become invalid? 
    I am not clear if there is any difference between the signature on a DoC and contract in principle. 

    I had only one experience of the changing signer of DoC but our notified body told nothing about the change of signature to us.
    (I suppose it took a few years util all the DoCs with ex-signer had replaced.) 
    Though it is possible that they just didn't notice about it. 

    However, I like Victor's solution the best, as we can't foresee how a person in charge in a competent authority think about it.
    Original Message


  • 12.  RE: Declaration of conformity sign off

    Posted 01-Jun-2020 10:51
    I agree with Richard, Salman and Victor on this issue. It has to be PRRC and has to be on job. 

    It's not like other business agreements.. If a CEO leaves a company it's a major change to your organizational structure, then if he was signing the DoC too so it's also affecting your products and processes. The change must have been reported in your management review and an auditor would notice it very early during the audit. 

    As Richard said, a person who is not present in the company can't ensure continued safety and effectiveness of the products.

    It's not always about what an auditor or CA would think, It's about doing the right thing pro-actively.

    ------------------------------
    Saqib Tanweer
    Manager QA/RA
    Toronto ON
    Canada
    ------------------------------

    Original Message


  • 13.  RE: Declaration of conformity sign off

    This message was posted by a user wishing to remain anonymous
    Posted 03-Jun-2020 08:32
    This message was posted by a user wishing to remain anonymous

    I still can't see what the difference between a contract and DoC. 
    If a person who is not present in the company can't ensure continued safety and effectiveness of the products, the same thing should happen to the validity of contract. 

    Also, I suppose the person who took over the position of ex-signer can't escape from the responsibility if he/she had signed DoC by him/herself or not. 

    However, unlike a contract, DoC sometimes accompanies with a product and, in such a case, people might feel it strange to see a document signed by the ex-employee.
    Original Message


Related Content