According to Article 2(3) of Regulation (EU) 2017/745, a custom-made device is any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of their professional qualifications which gives, under their responsibility, specific design characteristics and is intended for the sole use of a particular patient. Typical examples include dental work, orthopedic insoles, epitheses, or individually manufactured implants. A specific, shortened conformity route applies: Article 52(8) refers to the procedure set out in Annex XIII, and according to Article 20(1), these products do not bear the CE marking. Nevertheless, the requirements of Annex I must be met.
Definition and Legal Exceptions
The definition contains two explicit counter-exceptions. Mass-produced devices which need to be adapted to meet the specific requirements of any professional user are not considered custom-made devices. Likewise, devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person are also excluded. Thus, the decisive factor is not the individuality of the result, but the method of manufacture and the origin of the design decision. MDCG 2021-3 distinguishes these cases as adaptable and patient-matched products, which undergo the regular conformity assessment path with CE marking. Consequently, additively manufactured products from parameterized series processes are often not custom-made devices.
Procedure According to Annex XIII
Before placing a device on the market, the manufacturer or their authorised representative draws up the statement referred to in Section 1 of Annex XIII. It contains the name and address of the manufacturer and all manufacturing sites, data allowing identification of the device, the statement that the device is intended for exclusive use by a particular patient identified by name, an acronym or a numerical code, the name of the person who issued the prescription, the specific characteristics of the product as specified by the prescription, and a statement that the device conforms to the general safety and performance requirements set out in Annex I, including a justification for any requirements that have not been fully met. Section 2 requires documentation to be kept available regarding manufacturing sites, design, manufacture, and performance, while Section 4 requires the statement to be kept for at least ten years, or fifteen years in the case of implantable devices.
Labeling, UDI, and Class III Implants
Custom-made devices do not bear a CE marking but must be identified as such; for products delivered sterile, Annex I Section 23.3 explicitly requires this label on the sterile packaging. The UDI system under Article 27 does not apply to custom-made devices, and the summary of safety and clinical performance is also not required. A significant tightening applies to Class III implantable custom-made devices: according to the second subparagraph of Article 52(8), the conformity assessment procedure specified in Chapter I of Annex IX or, alternatively, Part A of Annex XI must additionally be carried out. In this scenario, a Notified Body is involved, even though the product still does not bear a CE marking.
Post-Market Surveillance and Vigilance
Post-manufacturing obligations do not lapse. Annex XIII Section 5 requires the manufacturer to review and document experience gained in the post-production phase, including clinical follow-up according to Part B of Annex XIV, to implement necessary corrections, and to report serious incidents and field safety corrective actions according to Article 87(1). For Class IIa, IIb, and III custom-made devices, the periodic safety update report (PSUR) according to Article 86 must be prepared; however, it is not part of the technical documentation according to Annexes II and III, but part of the documentation according to Annex XIII Section 2.
Distinction from Series Products, Investigational Devices, and In-House Manufacturing
Three similar cases must be distinguished from custom-made devices. Adaptable and patient-matched series products are industrially manufactured and require regular conformity assessment with CE marking; individual adaptation takes place within the intended purpose defined by the manufacturer. Investigational devices according to Annex XV also do not bear a CE marking but follow the authorization procedure for clinical investigations; their intended purpose is to gain knowledge, not to treat a patient. Devices manufactured and used only within health institutions according to Article 5(5) are subject to their own exemption regime. The classification must be made before manufacture because it determines documentation, labeling, and reporting obligations.
Relevance for clinical trials
Custom-made devices are not a substitute for a clinical investigation. If an individually manufactured product is used systematically on several patients to gain knowledge about safety or performance, it constitutes a clinical investigation under Article 62 of Regulation (EU) 2017/745, for which the authorization procedure and the requirements of Annex XV apply. The distinction between treatment with follow-up and prospective investigation determines the requirement for authorization, insurance, and informed consent documentation.
For manufacturers, this creates a two-track need for evidence: on the one hand, product-related documentation according to Annex XIII with clinical follow-up, and on the other hand, robust clinical data if a transition to a CE-marked, patient-matched series product is planned. Registry and follow-up concepts must then be designed to be methodologically sound at an early stage. Full-service CROs like Mediconomics support manufacturers in distinguishing between treatment and clinical investigation, in establishing follow-up and registry concepts, in applications according to Annex XV, and in medical writing for clinical investigation plans, follow-up reports, and clinical evaluations.
Frequently Asked Questions (FAQ)
Does a custom-made device bear a CE marking?
No. According to Article 20(1) of Regulation (EU) 2017/745, custom-made devices are exempt from CE marking. Instead, the statement according to Annex XIII Section 1 is issued, and the product is identified as a custom-made device.
Is a Notified Body involved in custom-made devices?
Only for Class III implantable custom-made devices. For these, Article 52(8) additionally requires the procedure according to Chapter I of Annex IX or Part A of Annex XI. All others do not require a Notified Body.
Is a 3D-printed, patient-specific implant automatically a custom-made device?
No. If it is created in an industrial series process from parameterized data, the exception to the definition applies; it must then be assessed regularly as a patient-matched product.
Regulatory References
- Regulation (EU) 2017/745, Article 2(3) – Definition of custom-made device
- Regulation (EU) 2017/745, Article 52(8) and Annex XIII – Procedures for custom-made devices
- Regulation (EU) 2017/745, Article 20(1) and Article 27 – CE marking and UDI system
- Regulation (EU) 2017/745, Article 86 and Article 87(1) – Periodic safety update report and vigilance
- MDCG 2021-3 – Questions and Answers on Custom-Made Devices
