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Joseph Nguyen
MDR Program Manager at 3Shape
February 2017
EC Declaration of Conformities – required content
< 1 min reading time

Hello everyone,

What’s the content of your DoCs?

According to the EU Official Journal published in 2008, the required content are:
“1. No xxxxxx (unique identification of the product):
2.Name and address of the manufacturer and/or his authorised representative:
3.This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
4.Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):
5.The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: ………
6.References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:
7.Where applicable, the notified body … (name, number)… performed … (description of intervention) … and issued the certificate: ….
8.Additional information:

Signed for and on behalf of: ………………………….

(place and date of issue)

(name, function) (signature)”

I’m particular interested in knowing whether or not one can avoid Point 6 “References to the relevant harmonized standards used or references…..”?

In my relatively short career within RA, I’ve never seen a DoC that contains a list of harmonized standards as this would require too much maintenance. The DoC format that i’m used to only contains references to applied Directives/Regulations and so far none of the notified bodies involved have commented this.

What’s your experience?

BR
J

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Posted by Joseph Nguyen
Asked on February 10, 2017 12:00 am
180 views
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Julie Omohundro My experience is the same as yours. I am used to seeing them listed in the Essential Requirements Checklist. I think this is a better place to list them. I guess the NBs agree

PS You can google the names of the two documents and find lots and lots of examples and templates.
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Joseph Nguyen Thanks for the input, Julie. It's well noted.
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Unfortunately, these are mandatory fields (EEC 93/42) and you should integrate relevant information in your DoC.
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Antonin Cuc In the each of Member State EU, there are declared Authorised body and Authorities bodies - for the each segment of defined dangerous products - there are the international agreement to respect the Conclusions from lists of Protocols with cerrtifications Products - You could take as a Producer from the member State to the some else Authority body to decision about mandatory respects the Lists of the Directives of New Approach vhich you should respects, so as contextual harmonised list touched EN standards, duties in Clinic Tests, mandatory parameteres of main Technician requirements of Products before to finish agreements for free Markt EU, etc. There are some variants to supervised constant Quality of Products, responseability of Producer, Supervisors - and continual controlling processing, innocations, etc. When there are in international Market some Quality problems - It should be immediately international announced, rescue Market EU, including to decide about satisfactions..
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It's mandatory by MD directive and it's something important to follow for you, NB, and... customers..
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What is your medical device class? Yannis is righty, normally you write there the harmonized standard with your product like DIN EN 61010-1:2011 in a doC for a IVD (98/79/EC) device.
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Karen Zhou Based on my own experience, we need to provide harmonized standards on the declaration of conformity. With the new MDR coming up, it appears that EU will require not just harmonized standards, but also common specifications (CS).
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Nebrido Santiago Prior to the revision, point 6 is optional - i've some companies listed them even not required but with the new propose eu regulation its now a mandatory.
If you have a periodic review of your whole tech docs you will cover this anyway as part of the maintenance
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Annika Fahlén You need to share which harminized standards that have been applied in both the DoC and in the technical file. You could use an appendix which may be easier to keep updated with a reference in the DoC.
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Aaron Liang I have seen it listed on the DOC as per the statutory interpretation but I think there is flexibility on how you list or reference it depending on your NB and the product. For example it may make sense to list the DOC if you only have 13485 and a relevant product standard which are relatively static and don't require much in the way of maintenance.
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Joseph Nguyen Hi Yannis, I'm well aware that it's required content but why is it that many manufacturers don't have this information in the DoC and it's seemingly accepted by notified bodies? :) so it seems that there's a certain presidency in the industry that contradicts the directive.
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Fabio Carmonini According to my knowledge, the list of harmonized standards on the Declaration of Conformity is NOT explictly requested by 93/42 MDD, BUT it is requested by Reg.768/2008, IEC 17050-1 (not specific for MDD), Machine directive 2006/42/EC (not specific for MDD), it will be for new EMDR (Annex III) and in particular is requested by Blue Guide 2016:
http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=7326

Look for paragraph 4.4:

"5. All relevant Union harmonisation legislation complied with; the referenced standards or other technical specifications
(such as national technical standards and specifications) in a precise, complete and clearly defined way; this implies
that the version and/or date of the relevant standard is specified. "

My conclusion: a NB could also accept a Declaration without list of harmonised standard (since there is no obligation from 92/42 MDD), anyway I strongly suggest to include the list of the EN standards, when possible
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Joseph Nguyen Dear all, I think we all agree on what's required (and not required) according to the MDD - no doubt about that part.

What I'm interested in is the justification for NOT having direct references to harmonized standards in the DoC, because there must be some kind of "best practice" hence the acknowledgement of so many NBs.
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Ales Martinovsky Hi everyone, We also see huge variations among notified bodies approach. Some of them even do not require list of standards other than reference to relevant directive (MDD 93/42/EEC). Some manufacturers print "date of validity" on the DoC, in relation to validity of certificate. This is an other case of non undestanding the fundamentals... This type of "variation" makes things difficult in case that one competent authority starts to be more strict, like recently in the Czech Rep.
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Julie Omohundro Joseph, simply put, if the NBs haven't required companies to do something, many companies are not going be doing it, and many of those who are doing it are not doing it because their NB required them to do it, but because it was in the MDD, and they thought this meant that they had to do it.
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In my experience, the applicable harmonized standards aren't required to be in the DoC in the current version of the MDD but will be in the new EU Medical Device Regulation that should be published later this year.
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Karen Zhou Some companies choose to include these references for different reasons. It depends on your company. They are not required by the Notified Body. But as I mentioned earlier, the new MDR will change things.
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Eddie Anderson, RAC I've found that it's many times dependent on the NB; some are more strict about this than others; and also dependent on the product; if, for instance, the product does not require NB approval and is self-declaration, the company may not include all of the required information. I don't think it is more a matter of enforcement rather than requirement. The enforcement might be tightened with the new MDR.
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Harmonised standards are reported in several declarations of conformity I saw. It is true, in some case, they are not reported. However, the greatest part of European regulations about whatsoever product certification imposes (each with its words) reporting the standards actually followed by manufacturer during the risk management process for enhancing the effectiveness index of the adopted risk control measures. So my suggestion is to report at least the main standards used to manage the "device-itself" sources of risks, e.g. for electromedicals IEC 60601 with ISO 14971, for low-voltage equipments the IEC 61010, for machinery the harmonised A standards (ISO 12100)... and other rules only if they actually have been completely followed for design choices. I think it is the correct mindset to proceed, in my experience. I guess I clarified your doubts.
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My experience is that there is a product specification which *does* list the harmonized standards that it complies with, and this is referenced on the certificate. If the standards change, then it's good to have documented evidence is that the manufacturing is compliant with the updated standards. So you don't just update only the list every time something changes as there might be a need for a real change. E.g. Compliance to 11xxx might stay at an old version for 1-2 years past a new one coming out, till the validation cycle has gone past and compliance with the new one is confirmed.
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Lorenz Runge Hi folks,
this situation shows the gap between intended theory and the real practical life of the european legislation. In theory the applied standards shows up the pathway to reach compliance with the essential requirements. For this reason it makes sense to list them in the declaration of conformity.
In practice there are so many standards (that are permanently changing) you have to show compliance with, that your declaration of conformity starts to become a running gag.
We do have in our technical documentation chapter called " list of applicable and applied standards" and this list is referenced in our declaration of conformity.
That´s how we addressed the MDD requirement and makes it still feasible.
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