Drafting the Annex IV declaration for self-declared devices
A class I medical device under Regulation (EU) 2017/745 and a class A in vitro diagnostic under Regulation (EU) 2017/746 reach the market on the manufacturer's own declaration. No notified body reviews the file, so the EU declaration of conformity is the document that carries the claim. We draft it with you, item by item against Annex IV, from the technical documentation you already hold.
Who issues the declaration
The route is set by the conformity assessment article, not by preference:
"Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III." (MDR Article 52(7))
For IVDs the parallel text reads: "Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III." (IVDR Article 48(10))
The order matters. The technical documentation comes first and the declaration follows it. A declaration drafted before the file exists declares nothing.
What Annex IV requires
The minimum content is fixed. Annex IV lists, among other items, the name and SRN of the manufacturer and, if applicable, of its authorised representative; a statement that the declaration is issued under the sole responsibility of the manufacturer; the Basic UDI-DI; the product and trade name with its intended purpose; the risk class under the rules of Annex VIII; the conformity statement; references to any common specifications used; and the place and date of issue with the name and function of the signatory.
Article 19(1) adds that the declaration "shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available." Article 19(2) requires a single declaration where other Union acts that also call for a declaration apply to the same device.
What we do
We check that the classification rule you rely on is the one Annex VIII actually applies, and that the class on the declaration matches it. We confirm that the Basic UDI-DI, the SRN and, where you have appointed us, our authorised representative details are entered exactly as they appear in EUDAMED. We draft the declaration against every Annex IV item, list the harmonised standards and common specifications your file relies on, and prepare the language versions you need for the Member States where the device is sold. When your device, standards or classification change, we update the declaration with you.
What stays with the manufacturer
The technical documentation under Annexes II and III is yours to draw up, and the declaration is yours to sign. Article 19(3) is direct about what signing means: "By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device." We do not write technical documentation or clinical evaluations, and we are not a notified body.
When a notified body is still involved
Class I devices placed on the market in sterile condition, with a measuring function, or as reusable surgical instruments (Is, Im and Ir) need a notified body for those aspects, and the declaration must then identify the notified body and the certificate. Sterile class A IVDs follow the same logic. We flag this before drafting, not after.
How to start
Send your device list with the classification you have applied. We reply with a written quote per declaration. If you also need an EU authorised representative, both can run under one engagement.
FAQs
Can a class I manufacturer sign its own declaration?
Yes. Under MDR Article 52(7), class I devices other than custom-made or investigational devices are declared by the manufacturer after the technical documentation in Annexes II and III has been drawn up. Class I devices that are sterile, have a measuring function or are reusable surgical instruments also need a notified body for those aspects.
What language must the declaration be in?
Article 19(1) requires the declaration to be translated into the official Union language or languages required by the Member States where the device is made available. We prepare the language versions you need.
Do you write the technical documentation?
No. The technical documentation under Annexes II and III stays with the manufacturer. We draft the declaration from it and check every item against Annex IV.