The word “Declaration of Conformity” is written 38 times on the EU MDR 2017/745. This is, if I may say, a pillar on the Medical Device Regulation process.
I know when you read, the requirements, this looks easy. It’s just a document that you sign to congratulate yourself of the great job you have done and to swear that you have respected all the laws.
Pretty strange, as at the end for class higher than class I, anyway the Notified Body will verify it.
But in reality, this is also a checkpoint for the company. They will not sign it before all the Technical Documentation is ready. This will be the document signed by the Management Representative which will give him the power and responsibility to say that the product is ready for launch.
What a ritual.
Don’t miss on this article the free template provided to you regarding the Declaration of Conformity. In case you need more documents to help you with your projects, check here.
Table of content
What is a Declaration of Conformity for medical devices?
You can also call it DoC if you prefer.
This is a document that is written by the Medical Device manufacturer. There is no specific format so this means you have to open your editing software and start write what is required to be on this document.
Stay until the end because I have a creative idea for you. So please read the last box at the bottom of the article when you’ll arrive there.
The content is described on Annex IV of the MDR 2017/745.
This document is an evidence that the manufacturer of a CE marked product confirm its compliance to the applicable legislation.
On my interpretation, this document should be considered like a promise on the honor that the manufacturer respect the rules defined.
Rules for the EC Declaration of Conformity
Let me list you a summary of some specificity for the EU Declaration of Conformity. These are listed on Article 19 of the MDR 2017/745.
You should include a statement that says that you are fulfilling the MDR 2017/745 requirements
The EU Declaration of Conformity should continuously be updated.
This means that you should include an expiry date on it. I usually put 1 year.
Or you should stipulate on a procedure like “Change management” when a change should trigger the update of the Declaration of Conformity.
Note: Have a look at the chapter about the transition to MDR & IVDR
The EU Declaration of Conformity should contain some minimum information. Those information are listed on Annex IV of the Medical Device Regulation MDR 2017/745.
I will provide more information on next chapters “Minimum content of the Declaration of Conformity”.
The Declaration of Conformity should be written on an official Union language.
But if you are making this DoC to another Member State, you’ll need to translate it to the official language of this country.
In the case your products needs a declaration of conformity for many legislation, you can list all the compliant legislation on one document.
So no need to create 3 or 4 declaration of conformity.
The minimum content of the Declaration of Conformity is listed on Annex IV. But the European Union Commission can still adopt a delegated act to update that in the case of technical progress.
This is authorized by Article 115 of the MDR.
Minimum content of the EC Declaration of Conformity
What is the minimum requirement for the Declaration of Conformity? This is described on Annex IV of the MDR 2017/745.
To identify the legal manufacturer, you should write on the Declaration of Conformity its name or the registered trade name or registered trade mark.
SRN stands for “Single Registration Number”. This number is provided by an electronic system that should be set up by the European Commission. Check Article 30.
So, as soon as you have this SRN, you’ll need to include it on your Declaration of Conformity.
In the case you have an Authorised Representative, you should also include his SRN.
You should indicate the place of business, with contact detail of both the Manufacturer and the Authorised Representative (if applicable)
The DoC should contain a statement like this one:
This declaration of conformity is issued under the sole responsibility of [MANUFACTURER NAME]
For those that don’t know what is the Basic UDI-DI, I refer you to another article I wrote about UDI.
The Basic UDI-DI should be requested for a group of product. As soon as you have it, you should incorporate it on the Declaration of Conformity.
You’ll need to identify now the product. The way you’ll provide should be clear so we can have no doubt that this DoC is linked to the product listed.
For that you can use:
- Trade name
- Product code
- Catalogue number
- or other unambiguous reference (Photograph…)
- Intended purpose
The risk class as defined by Annex VIII of the Medical Device Regulation MDR 2017/745 should be included. If this is something that is completely unknown to you, I also have an article that you should read.
As described on previous chapter, you’ll need to write a statement that is saying that you comply to this regulation.
But in the case your product comply to other ones, you can also include them.
The device covered by the present EU declaration is in conformity with the (EU) MDR 2017/745 and with the [OTHER UNION LEGISLATION].
In the case you are using a Common Specification to declare your conformity, you’ll need also to list them.
In the case your product is:
- Class Is
- Class Im
- Class Ir
- Class IIa
- Class IIb
- Class III
Everything except class I, you’ll need to include some information about your Notified Body.
- Notified Body identification number
- Description of the conformity assessment procedure
- The CE Certificate number
As mentioned on the title of this chapter, these are the minimum requirements. But you can add more information if needed. This is up to each manufacturer
At the end of this document you need to identify some key information
- Place and date of issue
- Name and function of the person who signed
- If applicable the indication for and on behalf of who this person signed
One information that I would recommend to clarify is the validity of this document.
For that, you can use many ways. You can mention:
- Valid for X years
- Expiry date: DATE
Mindmap of the requirements
I created this mindmap to summarise the information mentioned previously. You will then be able to upload it and use it as a checklist for the creation of your declaration of conformity.
Technical Documentation Templates
- Template compliant to requirements of MDR 2017/745 Annex II and III.
- Formatted with the chapters already defined.
- Guidance provided to help you identify the content to include
- General Safety and Performance Requirements compliant to Annex I.
- Include guidance to prove evidence to the requirements.
Good Declaration of Conformity Practice
One good practice is to create a specific procedure for the “Creation, maintenance and storage of the Declaration of Conformity”.
But this can also be embedded inside another bigger procedure if you prefer. You just need to write what you are doing somewhere on your quality management system.
This procedure can then define how this declaration should be created with the reference to a template. This would avoid that the DoC has multiple formats which can confuse an auditor.
The rules for the maintenance of DoC can be included. The validity period and the reason for the update should be included.
For example, in the case the person who signed the declaration of conformity left the company, you should mention that a backup person should sign a new version.
As this declaration of conformity should be available at any time when required, the record retention process should also be defined. Or if you have a separate record retention procedure, you should consider this document as “Vital” unless you use another wording.
MDR & IVDR transition
One of the important question to answer, is when to change your Declaration of Conformity while there is a transition for MDR 2017/745 and IVDR 2017/746.
If you read Article 19th of the MDR, you can see that you need to update continuously your Declaration of Conformity.
And what triggers this update?
On Article 52(7), for class I products, it is mentioned that the manufacturer should first draw the technical documentation and then issue the Declaration of Conformity.
This means that a change to the technical documentation is a trigger to the update of the declaration of conformity.
So, if you ask yourself, when you need to update your Declaration of Conformity during the transition, use the Technical File update approach.
As soon as you update your technical documentation to make it compliant to the MDR or IVDR, you should issue a new DoC with the appropriate statement.
For products that still are under MDD because they have a certificate, the DoC can be changed when the requirements to MDR or IVDR will be fulfilled.
But for all products involved on the Hard Transition, they will need to get updated as of May 26th, 2020 for MDR and May 26th, 2022 for IVDR.
Think out of the Box
Example: Declaration of conformity Template (MDR & IVDR)
I captured all the information that are needed on the DoC in this template. I did highlighted in yellow mark the elements that you should change. This is suitable for Class I, IIa, IIb or III. But if you need more than only the DoC, check all the templates for complying to MDR 2017/745 at https://school.easymedicaldevice.com/shop/
Don’t forget to leave a comment if you have a question on the Declaration of Conformity or DoC.
Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at email@example.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.