The Declaration of Conformity is an important legal document in which manufacturers declare the conformity of their medical devices. In this article you can read about the mistakes you absolutely have to avoid in order to make sure there are no legal consequences.
If you want to write a conformity assessment that complies with the regulations, then I’d recommend reading the ZLG EK-MED 3.9 A 4 document. You can even find a suggestion for the wording there, which you can largely adopt.
According to the ZLG, a Declaration of Conformity must contain:
Naturally, my team and I are happy to:
This means that you can be sure that this document also meets all the regulatory requirements. Don’t give your competitors an unnecessary chance to pester you with warnings.
There are far-reaching civil and criminal consequences of an unauthorized or incorrect conformity assessment. For this reason, you should define - for example, in a process instruction in your QM system - who is responsible for creating this important document and who is responsible for approving it. For small and medium-sized companies, this could be the manager.
You must not declare conformity until you have gone through the conformity assessment procedure for the device. Depending on the class of the medical device, this may require an EC certificate from the notified body.
But you must have declared conformity before affixing the CE mark to your device.
A declaration of conformity must refer precisely to an identifiable device or device type. This identifiability is usually achieved through:
A declaration of conformity for a medical device class is not permitted.
As the manufacturer, you must have the conformity assessment at hand as part of the technical documentation for the device and you must be able to submit it at any time on request. A lot of manufacturers even publish them on their websites.
A wording that does not contain any limit in terms of the period of validity does not meet the regulatory requirements, such as those of the ZLG.
You can limit the validity, for example:
Make sure that you do not refer to "whole" standards in the Declaration of Conformity, because if you do you’ll have to comply with the whole standard, even if parts of it don’t apply to you at all.
In addition, you would have to amend the Declaration of Conformity every time a standard changes.