Regulation (EU) 2017/745, known as the MDR, provides a specific regime for custom-made medical devices. This regime is often presented as a simplified route, sometimes even as a form of exemption. That is a mistake.
A custom-made device is not a “personalised” device in the everyday sense of the term. Nor is it a device that is simply manufactured on request, configured from a set of options, adjusted after manufacture or offered in a particular size. To qualify for the regime applicable to custom-made devices, a device must meet a strict definition and follow a specific procedure.
The subject matters, because incorrect qualification creates two opposite risks: wrongly applying a specific regime to a device that should follow the general conformity procedure, or needlessly imposing a classic CE marking scheme on a device that does genuinely fall under Annex XIII.
It should nonetheless be noted that, in the absence of an explicit exception in the MDR (concerning the affixing of a UDI, for instance), manufacturers of custom-made devices must comply with almost the entire Regulation. The custom-made device regime is therefore not a way of escaping the regulatory compliance effort.
The MDR definition of a custom-made device
Article 2 of the MDR defines a custom-made device as a device specifically made in accordance with a written prescription of a person authorised by national law by virtue of their professional qualifications, and intended for the sole use of a particular patient in order to meet their individual conditions and needs. Three elements are essential.
Specific manufacture. The device must be specifically manufactured. It is not a standard product available in stock, even if that product can subsequently be adjusted or selected according to the patient’s anatomy.
Written prescription. The device must be manufactured in accordance with a written prescription, issued by an authorised person — for example a healthcare professional qualified under the applicable law — and setting out the specific design characteristics of the device.
Sole use by a particular patient. Identification may be by name or based on a code, depending on the applicable documentary requirements, but the use must genuinely be individual.
A dental appliance produced from the prescription of a dental surgeon for an identified patient may fall under the custom-made regime. Conversely, a device manufactured in series in several sizes and then selected or adjusted for a patient does not automatically become a custom-made device.
What the custom-made regime is not
The most frequent confusion is to equate “custom-made” with “personalised”. Yet the MDR clearly distinguishes custom-made devices from devices that are series-manufactured and adapted to the needs of a user or patient.
A configurable, parameterisable device, or one offered in variants, may still be a series-manufactured device. This is notably the case where it is produced using repeatable industrial processes, on the basis of an already established design, and then adapted from dimensions, size options or predefined parameters.
The MDCG 2021-3 guidance stresses this distinction between custom-made devices, adaptable devices and patient-matched devices. The criterion is therefore not merely the apparent personalisation of the product, but the combination of a written prescription, specific design characteristics and sole use for a particular patient or user.
This distinction is decisive. A manufacturer cannot choose the custom-made regime to avoid the CE marking of a device that in reality results from series manufacture, even if each unit is adjusted to a patient.
The applicable procedure: Article 52 and Annex XIII
Article 52 of the MDR provides that manufacturers of custom-made devices follow the procedure set out in Annex XIII and draw up the statement provided for by that annex before placing the device on the market.
This statement is not a classic EU declaration of conformity within the meaning of Annex IV. It is specific to custom-made devices and must, in particular, make it possible to identify the manufacturer, the device concerned, the patient or user for whom the device is intended, and the person who issued the prescription. It must also indicate that the device is intended for the sole use of that patient or user.
The custom-made device does not bear the CE marking and is labelled “custom-made device”. It must be accompanied by the Annex XIII statement, made available to the identified patient or user, under the conditions laid down by the MDR.
The obligations that remain applicable
The custom-made regime does not relieve the manufacturer of the obligation to demonstrate the safety and performance of the device. The general safety and performance requirements of Annex I remain applicable, to the extent relevant.
Documentation. The manufacturer must hold documentation sufficient to demonstrate the device’s conformity with the applicable requirements. This documentation, distinct from the technical documentation of Annex II, must cover the design, manufacture and performance of the device: the elements needed to understand the prescription, the materials used, the manufacturing processes, the controls carried out and the justification of the choices made.
Quality management system. The obligations to establish and maintain a quality management system proportionate to the device’s risk class apply. Assessment of the conformity of the quality management system by a notified body is required for custom-made implantable class III devices, and the certificate issued by the notified body must be registered on EUDAMED.
Retention. The manufacturer keeps the statement and the documentation for 10 years after the device is placed on the market — 15 years for implantable devices.
Post-market surveillance. The obligations of post-market surveillance, and in particular post-market clinical follow-up, do not disappear. The manufacturer monitors the data arising from the use of its devices, analyses relevant feedback, takes account of incidents and implements the appropriate corrective actions where necessary. As with the other life-cycle processes (risk management, clinical evaluation), these activities may be conducted on families of products (grouped by intended purpose, materials or manufacturing process) rather than on each individual custom-made device.
PRRC. The designation of a person responsible for regulatory compliance (PRRC) remains applicable to manufacturers of custom-made devices. The MDR also provides clarifications on how the required experience is to be demonstrated in their case.
Vigilance. Vigilance remains applicable. A serious incident involving a custom-made device must be handled and reported in accordance with the requirements of the MDR and the national arrangements — in France, to the ANSM.
The specific case of implantable class III custom-made devices
Implantable class III custom-made devices are subject to heightened attention. In addition to the Annex XIII procedure, Article 52 of the MDR provides for the application of a conformity procedure involving a notified body (Annex IX, Chapter I).
This point is often underestimated. Not all custom-made devices are subject to the same level of procedural requirement. Where a custom-made device is implantable and class III, the manufacturer must anticipate the involvement of a notified body in the quality management system.
Moreover, the requirements specific to implantable devices — traceability, certain information to be supplied — must be examined carefully. The “custom-made” qualification is not enough to set aside the requirements linked to the implantable nature of the device.
Common mistakes to avoid
Error 1: qualifying as custom-made a device that is merely adapted. An orthosis, an instrument, an implant or an accessory selected from a range and then adjusted is not necessarily a custom-made device.
Error 2: believing that the absence of CE marking means the absence of MDR compliance. The custom-made device does not bear the CE marking, but it remains subject to significant regulatory requirements.
Error 3: neglecting the prescription. Without a written prescription setting out specific design characteristics, the very foundation of the custom-made regime is fragile.
Error 4: repeatedly producing similar devices while invoking custom-made status, when the actual process corresponds to personalised series manufacture. In such a case, the regulatory qualification of the product must be re-examined.
Error 5: forgetting the post-market obligations: surveillance, vigilance, documentation kept up to date, analysis of feedback and corrective actions.
Key takeaways
The custom-made device is a specific MDR regime, but it is not a zone outside regulation. It rests on a precise definition, a written prescription, sole use for a particular patient or user, and a documentary procedure specific to Annex XIII.
The central question is therefore not “is the device personalised?”, but “does it strictly meet the MDR definition of a custom-made device?”. In practice, the qualification must be documented on a case-by-case basis: it depends on the intended purpose, the manufacturing method, the prescription, the degree of standardisation, the patient concerned and the market-placement strategy.
For manufacturers, the challenge is twofold: avoid applying the custom-made regime improperly, but also avoid over-qualifying a device that does genuinely fall under Annex XIII. In both cases, a structured regulatory analysis remains essential before placing the device on the market.
Regulatory source: Article 52 and Annex XIII of Regulation (EU) 2017/745 — EUR-Lex