How to write a Declaration of Conformity? (MDR and IVDR)

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.

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.

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.

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.

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.