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MDR 745 - EU Declaration of Conformity - Signature Requirements

lacri

Registered
#1
Currently in many company the DoC is signed by the Managment (or the CEO).
Considering the MDR, who signes the EU declaration of conformity?
The person responsible is the same as the one who signes the DoC and releases the product in the market like the QP- pharma?

It is not clear in the MDR Infact, the MDR Regulation states that:
  1. art. 15 Person responsible for regulatory compliance "shall at least be responsible for ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released"
  2. ANNEX IV EU DECLARATION OF CONFORMITY says that " 10. 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"
Someone can solve this issue?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
I think it can be anyone, as long as the org formally bestows that authority on them (typically, somewhere in the QMS).
 

Mikilk

Involved In Discussions
#3
I would say it can be anyone from the top management as long he/she got the authorization for that but I do think that due to the fact that the PRRC has some responsibility to make sure the appropriate processes are in place, it is good practice to have PRRC sign on this DOC in additional to the formal qualified person
 
#4
TLDR: persons officially designated to represent the manufacturer (i.e. at the legal entity level, not QMS). The QMS might facilitate in official delegation of that power of representation (intuitively the PPRC is a prime target), but the system should also ensure to look out for changes in management setup that might change the validity of the DoC's signature state. The PRRC should review and bite into change control like a pitbull if they take this role upon them due to liability-risk.

To get (EU) Declarations of Conformity (DoC) the context is important. I'll be quite definitive on the current (2019-10) state of the matter so other Elsmar visitors do not need to go on a web-browsing adventure.
It is a 'generic' requirement of several EU regulations/directives. It is also specified in the EU's blue guide (and less of interest right now: DECISION No 768/2008/EC), which then lies down further guidance in ISO 17050-1 (the DoC) and -2 (The supporting design file).
It is usually a singular record as when multiple regulations apply, their results should be integrated into one DoC, where a dossier of relevant indivudal DoC's is regarded as adequate.

The highest level document, the blue guide, states: "By drawing up and signing the EU declaration of conformity, the manufacturer assumes responsibility for the compliance of the product."
The purpose of the Declaration of Conformity is never stated broadly in the literary journey's I've made, but logically speaking it is your recorded promise to the outside world, customer and regulator alike, that your device conforms to mentioned/applicable regulations and standards "attestation of conformity to meet demands from the market and regulators for confidence". By extension I would assume it serves as evidence of taking upon oneself the obligation to ensure that product does conform, and claims and expectations will be met which can be called upon in case of willful breach or gross negligence to show you claimed awareness of the requirements.

As the manufacturer as an entity is the one assuming the responsibility for compliance, one would expect the person(s) signing the DoC to have that power of representation. In all the countries' laws I know, this is not a matter of the QMS, but usually also involves registering at the Chamber of Commerce or a similar entity.
This is substantiated by point 8 on the model declaration: "The date of issue of the declaration; signature and title or an equivalent marking of authorised person (214) (215); this could be any date after the completion of the conformity assessment"
Footnote (214) states "This could be the Managing Director of the company or another representative of the company to whom this responsibility has been delegated."
The ISO standard simply states in 6.1 g) "the signature (or equivalent sign of validation), name and function of the authorized person(s) acting on
behalf of the issuer;"
Also of interest is 10.2 c): "The issuer of the declaration of conformity shall have procedures in place to re-evaluate the validity of the declaration of conformity, in the event of ... changes in the ownership or structure of management of the supplier, if relevant"
As such items are not listed elsewhere within a DoC, this means you should watch out for changes in representatives of the company, and update the DoC signatory accordingly.
Its annex A also states: 2) "The responsible issuer should be unequivocally specified. For large organizations, it may be necessary to
specify operational groups or departments." so some leeway giving the CEO at the top of the pyramid rest is explicitly allowed.
Annex A also states 7) "Full name and function of the signing person(s) authorised by the issuer's management to sign on its behalf should be given. The number of signatures, or equivalent, included will be the minimum determined by the legal form of the issuer’s organization."

On to the EU MDR:
The pertinent bit of the Annex IV is "10. 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."
for and on behalf of whom allows for clear delegation on every DoC. (Not limiting it to the Person Responsible for Regulatory Compliance (PRRC).
For the PRRC the important part is in Article 15.
"3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued."
While there is a responsibility to ensure conformity is checked before device release, and they have the responsibility to ensure both the DoC and its supporting documentation are there and up-to-date, it does not state that they must or should be the person signing the DoC.

This part does intuitively combine with the previous bit that efficiently speaking the PRRC is the person best suited to sign these (given that you implement the appropriate and explicit systems and delegations for it, including re-issuing it when the persons allowed to represent the company change). However, liability-wise it does not mesh well with some styles of change control that might be employed by companies, as a DoC already signed by such a person might continue to cover a 'trivial' change that they were unable to stop (different or higher-management approved it) or are simply unaware of. So the manner of change control should be an important exploration point for any PRRC thinking of taking the role upon them, and they should lobby hard to at least see every change, if not being a veto member whose signature cannot float upwards in their temporary absence.

ps. on translations "The EU declaration of conformity must be translated into the language or languages required by the Member State in which the product is placed or made available on the market (218)." & "If a translation of the EU declaration of conformity has been produced by another economic operator and is not signed by the manufacturer, a copy of the original EU declaration of conformity signed by the manufacturer must also be provided together with the translated version."
pps. the blue guide and the referenced ISO standard already contained the expectation that the version/date of the requirement documents (regulations, standards) is specified.
 
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