Glossar

EU Declaration of Conformity

The EU Declaration of Conformity is the legally binding written declaration by which the manufacturer assumes sole responsibility for a product meeting the requirements of Regulation (EU) 2017/745. It is regulated in Article 19, and its minimum content is specified in Annex IV. It represents the legal conclusion of the conformity assessment procedure and is a prerequisite for the CE marking to be affixed and the product to be placed on the market. Unlike a certificate from a Notified Body, it originates exclusively from the manufacturer and must be kept continuously up-to-date.

Legal Requirements under Article 19

Article 19, paragraph 1, requires the manufacturer to issue the declaration once they have demonstrated that the requirements of the Regulation are met. The declaration must be continuously updated, contain at least the information specified in Annex IV, and be translated into one or more official languages of the Union as required by the Member States where the product is made available. Paragraph 2 stipulates that for products subject to other Union acts that also require a declaration of conformity, a single declaration must be issued for all applicable acts, listing all relevant acts with their references. Paragraph 3 clarifies that by issuing the declaration, the manufacturer assumes responsibility for compliance with both the Regulation and all other applicable acts. Paragraph 4 authorizes the Commission to adapt the minimum content of Annex IV to technical progress through delegated acts in accordance with Article 115.

Minimum Content according to Annex IV

Annex IV requires ten pieces of information. These include the name, registered trade name or registered trademark, and the registration number of the economic operator as per Article 31, and, if applicable, the address of the authorized representative. Additionally, it must state that the declaration is issued under the sole responsibility of the manufacturer, include the Basic UDI-DI as per Annex VI Part C, product or trade name, product code or catalogue number along with a unique identifier for identification and traceability, the intended purpose, and the risk class according to Annex VIII. This is followed by the assurance of conformity, references to applied specifications, if applicable, the name and identification number of the Notified Body with procedures and certificates, any additional information, as well as the place and date of issue, name and function of the signatory, and the signature.

Issuance, Maintenance, and Retention

The manufacturer is responsible for issuing and updating the declaration; within their organization, the person responsible for regulatory compliance under Article 15, paragraph 3, ensures that the declaration is created and kept up-to-date. Changes to the intended purpose, product designation, certificates, applied specifications, or company data trigger an update; a version identifier and an issue date are therefore practically indispensable, even if Annex IV only requires the place and date. According to Article 10, paragraph 8, the declaration, along with the technical documentation and certificates, must be kept for at least ten years, or fifteen years for implantable products, after the last product has been placed on the market. Authorized representatives must have continuous access according to Article 11, paragraph 3.

Languages and Provision

The language requirement follows the market of distribution: the official language prescribed by the Member State where the product is made available is decisive. Multilingual declarations are permissible and common in practice. The declaration does not have to accompany every product packaging but must be made accessible to authorities, Notified Bodies, and economic operators in the supply chain upon request. Electronic provision is possible, provided that identifiability, immutability, and assignment to the respective version are ensured.

Distinction from Certificates, Markings, and Manufacturer’s Declarations

The declaration is not a test certificate. A certificate from the Notified Body documents the result of an external assessment, is time-limited, and is merely referenced in the declaration. The CE marking is the visible consequence of the declaration, not its replacement; it may not be affixed without a valid declaration. Furthermore, the declaration under Annex XV Chapter II Section 4.1 for investigational products in clinical investigations is to be distinguished: investigational products specifically do not bear a CE marking for the investigated intended purpose, and the declaration there merely confirms that the product complies with the basic safety and performance requirements apart from the investigational aspects. The declaration of conformity for custom-made devices under Annex XIII also follows its own provisions and does not replace the declaration under Article 19.

Relevance for clinical trials

For studies involving products not yet CE-marked, the declaration under Article 19 is not the relevant proof; it is replaced by the declaration under Annex XV. If, however, a product already placed on the market is investigated within its intended purpose, the existing declaration is part of the application documents and must be consistent with the investigated application.

If the investigated application deviates from the declared intended purpose, it regularly constitutes an investigation outside the intended purpose, for which the full requirements for clinical investigations apply. Full-service CROs like Mediconomics support sponsors in clarifying this classification before application and in keeping the declarations consistent with the study documentation.

Frequently Asked Questions (FAQ)

Who signs the declaration?

A person authorized to represent the manufacturer; Annex IV requires the name, function, and signature. Professionally, the person under Article 15 is responsible for ensuring that the declaration is created and kept up-to-date.

Must a separate declaration be issued for each product?

A declaration can cover multiple products, provided that all information required by Annex IV for each product is clearly assignable, especially the Basic UDI-DI, product code, intended purpose, class, and certificates.

What applies if a product is also subject to other legal acts?

According to Article 19, paragraph 2, a single declaration is issued for all applicable Union legal acts, listing each affected act with its reference.

Regulatory References

Regulation (EU) 2017/745, Article 19, paragraphs 1 to 4
Regulation (EU) 2017/745, Annex IV, points 1 to 10
Regulation (EU) 2017/745, Article 10, paragraph 8, Article 11, paragraph 3, and Article 31
Regulation (EU) 2017/745, Article 15, paragraph 3, and Article 20 on CE marking
Regulation (EU) 2017/745, Annex VI Part C, Annex XIII, and Annex XV Chapter II Section 4.1

Dr. Richard Smith

Dr. Richard Smith verbindet über drei Jahrzehnte medizinische, pharmazeutische und unternehmerische Expertise in der internationalen Arzneimittelentwicklung. Als Gründer und langjähriger Chairman von Pharmakopius International hat er den europäischen CRO-Markt mitgeprägt und bringt dieses Wissen heute als Autor und Berater bei Mediconomics ein. Als britischer Mediziner, promovierter Wissenschaftler und zertifizierter Biologe verläuft seine Laufbahn konsequent an der Schnittstelle von Klinik, Wissenschaft und Unternehmensführung. Seine Ausbildung umfasst einen Bachelor of Science, die medizinischen Grade MB ChB sowie einen forschungsbasierten Doctor of Medicine. Als Fellow der Faculty of Pharmaceutical Medicine des Royal College of Physicians (FFPM) gehört er zu jenem exklusiven Kreis von Medizinern, die Pharmaceutical Medicine als eigenständige Disziplin maßgeblich mitgestalten; ergänzt wird sein Profil durch das Diploma of Pharmaceutical Medicine, die Zertifizierung als Biologe (C.Biol., F.I.Biol.) sowie die Fellowship des Institute of Management (F.Inst.M.) – eine seltene Kombination aus medizinischer, naturwissenschaftlicher und betriebswirtschaftlicher Qualifikation. 1998 setzte Dr. Richard Smith mit dem erfolgreichen Trade Sale von Pharmakoplus International, einem international aufgestellten Dienstleistungsunternehmen mit Standorten in Großbritannien, Frankreich, Deutschland, Polen und den USA und über 100 Mitarbeitenden, einen Meilenstein seiner unternehmerischen Laufbahn; der Fokus lag auf pharmazeutischer Produktentwicklung von der präklinischen Phase bis zur Zulassung. Diese Expertise in paneuropäischer und transatlantischer Studiensteuerung, Regulatory Affairs und pharmazeutischem Projektmanagement macht ihn bis heute zum gefragten Sparringspartner für Sponsoren, die anspruchsvolle klinische Programme in multiplen Jurisdiktionen umsetzen. Seine fachliche Autorität spiegelt sich in zahlreichen Führungsrollen wider: als früherer Chairman der British Association of Pharmaceutical Physicians (BRAPP), früherer Vice-Chairman der Association of Independent Clinical Research Contractors (AICRC), früheres Mitglied des Medical Committee der Association of the British Pharmaceutical Industry (ABPI), Mitglied des Finance Committee der BioIndustry Association sowie Chairman des Livery Committee der Worshipful Society of Apothecaries. Darüber hinaus ist er Mitglied der British Medical Association, Fellow des Institute of Biology, Fellow des British Institute of Management sowie Fellow der Royal Numismatic Society. Bei Mediconomics schreibt und berät Dr. Richard Smith zu internationaler klinischer Arzneimittelentwicklung in den Phasen I bis IV, zum Aufbau und zur Steuerung multinationaler CRO-Strukturen, zu Regulatory Strategy in EU, UK und USA, zu Pharmaceutical Medicine und Good Clinical Practice (GCP), zu Medical Affairs und medizinisch-wissenschaftlicher Publikationsarbeit sowie zu Due Diligence, Lizenzierung und Trade-Sale-Prozessen in der Pharma-Industrie. Er spricht Englisch als Muttersprache sowie fließend Französisch und Deutsch – eine Grundlage für die reibungslose Zusammenarbeit mit Sponsoren, Prüfzentren und Behörden in ganz Europa.