The conformity assessment procedure is the procedure required under Article 52 of Regulation (EU) 2017/745 to demonstrate, prior to placing a product on the market, that it meets the requirements of the Regulation. The appropriate route depends on the product’s risk class; the procedures set out in Annexes IX, X and XI are available, and for custom-made devices Annex XIII additionally applies. This is not an approval procedure: it does not end with an authority’s authorisation, but with the manufacturer’s declaration, where applicable supported by certificates issued by a Notified Body. Only then may the CE marking be affixed.
The three procedural annexes
Annex IX governs conformity assessment based on a quality management system and an assessment of the technical documentation. Chapter I covers the quality management system, including application, audit, significant changes and ongoing surveillance, including unannounced audits; Chapter II covers the assessment of the technical documentation, including additional procedures; Chapter III covers the administrative provisions. Annex X governs the EU type-examination, in which the Notified Body examines a representative sample and issues an EU type-examination certificate. Annex XI consists of Part A on production quality assurance, leading to an EU quality assurance certificate, and Part B on product verification of individual products or batches. Annex X is always combined with Annex XI because type-examination alone does not cover series production.
Allocation by risk class
For Class III products, Article 52(3) requires the procedure under Annex IX; alternatively, the manufacturer may choose the route via Annex X in conjunction with Annex XI. For Class IIb products, paragraph 4 applies Annex IX Chapters I and III plus a documentation assessment under Section 4 for at least one representative product per generic product group; for implantable Class IIb products, each product must in principle be assessed, with a final list of exceptions including, among others, suture material, staples, dental fillings, screws, plates and wires. Alternatively, Annex X in conjunction with Annex XI is also possible here. For Class IIa products, paragraph 6 applies Annex IX Chapters I and III with a documentation assessment per product category; alternatively, Annexes II and III in conjunction with Annex XI Section 10 or 18 are sufficient.
Procedures for Class I products
For Class I products, under Article 52(7) the manufacturer declares conformity itself by issuing the EU declaration of conformity under Article 19 after preparing the technical documentation in accordance with Annexes II and III. A Notified Body is not involved. Three special cases depart from this principle: products placed on the market in sterile condition, products with a measuring function, and reusable surgical instruments. In these cases, Annex IX Chapters I and III or Annex XI Part A must also be applied, with the Notified Body’s involvement remaining strictly limited: to the manufacture and maintenance of sterility, to the metrological requirements, or to the aspects relating to reusability.
Additional procedures and custom-made devices
In addition to the main routes, the Regulation provides for specific consultation steps. Annex IX Section 5.1 governs the consultation procedure for clinical evaluation by an expert panel, Section 5.2 the consultation of a medicines authority for products incorporating a medicinal substance, Section 5.3 the procedure for products derived from non-viable tissues or cells, and Section 5.4 the procedure for substances that are absorbed; Article 52(9) to (11) refer to these and to Annex X Section 6. For custom-made devices, Annex XIII applies under paragraph 8; for implantable custom-made Class III devices, Annex IX Chapter I is added, alternatively Annex XI Part A. Under paragraph 12, the Member States determine the language of the documentation.
Distinction from authorisation, declaration and marking
The conformity assessment procedure is the act of demonstrating compliance, not the outcome. The EU declaration of conformity is the legal declaration issued by the manufacturer after completion of the procedure, and the CE marking is the resulting visible marking. A Notified Body certificate is an intermediate result with a limited validity of no more than five years under Article 56(2); it replaces neither the declaration nor the technical documentation. The procedure differs fundamentally from the medicinal product marketing authorisation procedure because no authority grants permission to market; regulatory control begins only with market surveillance. Nor is an ISO 13485 system certificate a conformity assessment procedure; it is voluntary evidence.
Relevance for clinical trials
The chosen route determines when and to what extent clinical data are reviewed. For Class IIa to III products, the Notified Body assesses the clinical evidence in accordance with Annex IX Section 4 and, under Section 4.8, prepares a report on the assessment of the clinical evaluation. Studies must therefore be planned so that reports are available at the time of application and are consistent with the intended purpose and the risk analysis.
If, for Class III, the consultation procedure with the expert panel is added, this extends the timeline and increases the requirements for substantiating the evidence strategy. Full-service CROs such as Mediconomics support manufacturers in aligning the clinical evidence base with the chosen route and in responding in a structured manner to the Notified Body’s questions on the clinical evaluation.
Frequently Asked Questions (FAQ)
Can a manufacturer freely choose the route?
Only within the alternatives provided for each class under Article 52. For Classes IIa to III there are two routes in each case; for Class I, self-declaration generally applies.
Does a certificate replace the technical documentation?
No. The certificate documents only the outcome of an assessment; the technical documentation remains with the manufacturer and must be kept up to date.
Is an ISO 13485 certificate sufficient?
No. It can support the assessment of the quality management system, but it does not fully cover either the product-specific documentation assessment or the Regulation-specific requirements.
Regulatory References
- Regulation (EU) 2017/745, Article 52(1) to (12)
- Regulation (EU) 2017/745, Annex IX Chapters I to III, in particular Sections 4 and 5
- Regulation (EU) 2017/745, Annex X and Annex XI Parts A and B
- Regulation (EU) 2017/745, Annex XIII on custom-made devices
- Regulation (EU) 2017/745, Article 19 and Article 56(2)
