A Declaration of Conformity is the manufacturer's claim

A CE mark on a device box reads, to most people outside the file, as a stamp of approval — something a regulator granted after checking the device over. What actually authorizes that mark is a document the manufacturer writes and signs itself: the EU declaration of conformity. A notified body's certificate can sit behind that declaration for a device that needs one, and often does. But the declaration is not the certificate, and treating the two as interchangeable misses the one feature of the document that actually matters — whose name is on it, and what that name is on the hook for.

Article 19 puts the claim, and the liability, on the manufacturer

Article 19(1) requires the manufacturer to draw up an EU declaration of conformity for each device, stating that the requirements of the Regulation have been fulfilled in relation to that device. Annex IV, which sets the declaration's minimum content, makes the ownership explicit rather than implied: item two of the annex requires a statement that the declaration is issued under the sole responsibility of the manufacturer. Not the notified body that may have reviewed the technical documentation, and not a distributor or importer further down the chain — the manufacturer, alone, is making the claim and carrying what follows from it being wrong.

What the document actually has to say

Annex IV's list is short but specific: the manufacturer's name and registered place of business, and its Single Registration Number where one has already been issued under Article 31; the sole-responsibility statement; the device's Basic UDI-DI; enough identifying detail — product name, code, or catalogue number — to trace the specific device the declaration covers; and the device's risk class under Annex VIII. Where a notified body was involved in the conformity assessment, the declaration also has to name that body and reference its certificate. None of this is boilerplate a template fills in once and forgets: the SRN field alone can't be completed honestly until the Article 31 registration this blog has already covered is actually in hand, which is exactly why treating the two registrations as one step causes a declaration to be drafted before it has anything real to reference.

The declaration doesn't wait for the certificate to be finished; it depends on it

For anything above Class I, self-declared devices, a notified body's involvement in the conformity assessment procedure comes first, and its certificate is what the declaration then cites as the basis for the class-appropriate parts of its own claim. That ordering matters because it's easy to read the sequence backwards — to treat the declaration as the manufacturer's own paperwork, running in parallel to a certificate process that's really the substantive check. It isn't parallel. The declaration is the document that asserts conformity to the whole Regulation, including everything the GSPR checklist has to trace hazard by hazard; the certificate, where one exists, is the evidence for the piece of that claim a notified body actually reviewed. A GSPR checklist is what makes the declaration's own sole-responsibility statement defensible rather than aspirational.

It's a living document, not a launch artifact

Article 19(3) requires the manufacturer to keep the declaration continuously updated. A design change, a new intended use, an updated harmonised standard the device now conforms to instead of the one it cited before — any of these can move the declaration out of date even where the underlying certificate hasn't yet been reissued. And the declaration doesn't get filed once and forgotten afterward: Article 10(8) requires the manufacturer to keep it, along with the technical documentation and any relevant certificate, available to competent authorities for at least ten years after the last device it covers is placed on the market — fifteen for an implantable device. A declaration that was accurate at CE marking and has never been touched since is a document quietly drifting out of sync with the device it claims to describe.

Where this meets the rest of the file

A declaration-of-conformity record that ties each Annex IV element to its actual source — the Article 31 SRN, the GSPR checklist behind the sole-responsibility statement, the notified body certificate it references where one applies — rather than treating the document as a form filled in once at launch, is previewed in the launch catalog. If your program maintains this differently, the shelf takes that correction directly.