The EU declaration of conformity is one of the most important documents in the regulatory file of a medical device. Through this document, the manufacturer declares under its sole responsibility that its device complies with all the applicable requirements of Regulation (EU) 2017/745 (MDR).
Beyond a mere administrative formality, the declaration of conformity constitutes a legal commitment. It is the precondition for affixing the CE marking and may be requested at any time by the competent authorities during a check or an inspection.
But what exactly must it contain? What are the mistakes most frequently found during MDR audits?
What is the EU declaration of conformity for?
The declaration of conformity is the official act by which the manufacturer attests that:
- the device satisfies the general safety and performance requirements of the MDR;
- the appropriate conformity assessment procedure has been carried out;
- the necessary certificates have been obtained where the involvement of a notified body is required;
- the technical documentation is available and kept up to date.
Without a valid declaration of conformity, a medical device cannot be lawfully placed on the European market. Annex IV of Regulation (EU) 2017/745 precisely defines its minimum content.
Who must draw up the EU declaration of conformity?
The only economic operator required to produce this declaration is the manufacturer. In practice, it is the person responsible for regulatory compliance (PRRC) who draws it up, in one or more of the official languages of the countries where the device is marketed, and who keeps it up to date.
Because of its legal nature, the manufacturer must keep the declaration available to the competent authorities, as well as to the other economic operators where relevant (authorised representative, importer, distributor).
Like any pivotal document linked to conformity, the EU declaration of conformity must be retained and kept available even after the last device has been marketed. Both the manufacturer and the authorised representative must retain it for 10 years from the placing on the market of the last device, or 15 years for implantable devices.
Mandatory content under Annex IV of the MDR
1 — Identification of the manufacturer and, where applicable, the authorised representative. Name and business name of the manufacturer (or registered trademark), the single registration number (SRN) of the manufacturer and that of the authorised representative where applicable, and the full address of the registered place of business of the manufacturer and its authorised representative. This information must correspond exactly to that on the labelling and the EUDAMED registration.
2 — Statement of responsibility by the manufacturer. An explicit wording must state that the declaration is issued under the sole responsibility of the manufacturer. This mention gives substance to the company’s legal commitment towards the authorities and users.
3 — Clear identification of the device. Name and trade name, product reference or catalogue number (or any other unambiguous reference, a photograph for example), intended purpose and Basic UDI-DI. The aim is to avoid any confusion about the product covered.
4 — Class of the device and procedure followed. Class of the device (I, Is, Im, Ir, IIa, IIb or III), the conformity assessment procedure applied and the MDR annexes used. This information demonstrates that the regulatory route chosen is appropriate to the level of risk.
5 — Explicit reference to the MDR. The declaration must clearly state that the device conforms to Regulation (EU) 2017/745. A generic wording of the type “compliant with the applicable European regulations” is insufficient. If other Union legislation also requires an EU declaration of conformity, the manufacturer gathers all the elements in a single declaration and lists the legislation concerned.
6 — Harmonised standards and common specifications applied. Harmonised standards, common specifications and other relevant technical references. It is recommended to indicate the full reference, the title and the applicable year or version.
7 — Information on the notified body. For devices requiring its involvement: name, identification number and reference of the certificate(s) issued. This mention allows the authorities to quickly verify the validity of the assessment.
8 — Place and date of issue. They make it possible to verify that the declaration is consistent with the version of the device actually placed on the market.
9 — Signature of the authorised person. The document must be signed by a person having the authority necessary to legally bind the manufacturer: name and function of the signatory, mention of the person on whose behalf the declaration is issued, and signature.
The 5 most common mistakes found during MDR audits
Error 1: reusing an old declaration derived from Directive 93/42/EEC. This is one of the most common non-conformities. Declarations drawn up under the MDD do not automatically meet the requirements of the MDR: the regulatory references, the documentary structure and certain obligations have evolved — even the name of the declaration differs. A new declaration must be established in accordance with Annex IV of the MDR.
Error 2: forgetting to update the declaration. The declaration of conformity is a living document. It must be reviewed at each significant change concerning the device, its classification, the applicable certificates, the standards used or the contact details of the manufacturer or the authorised representative. An obsolete declaration may be regarded as a major non-conformity.
Error 3: using withdrawn or superseded standards. Many manufacturers continue to cite versions of standards that no longer appear in the lists recognised by the European Commission. A withdrawn standard no longer confers the presumption of conformity. Regular regulatory monitoring is essential.
Error 4: having the declaration signed by an unauthorised person. The signature legally binds the manufacturer. When the signatory is not the legal representative, a documented delegation of authority must be available. Auditors frequently check this point.
Error 5: grouping regulatorily different devices in a single declaration. This approach is only acceptable if the devices share the same class, the same conformity assessment procedure, the same certificates and the same normative references. Otherwise, separate declarations or clearly structured annexes are necessary.
In summary
The EU declaration of conformity is far more than an administrative document: it constitutes the manufacturer’s official commitment towards the authorities, healthcare professionals and patients. An incomplete, obsolete or incorrectly signed declaration can call into question the regulatory conformity of a device and lead to observations during an audit or an inspection.
A regular review of this document, consistent with the technical documentation and the MDR certificates, is therefore essential to durably secure the placing of medical devices on the market.
Regulatory source: Annex IV of Regulation (EU) 2017/745 — EUR-Lex