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The definition turns on patient-specific design and prescription control. The device must be made in accordance with a written prescription from a person authorised by national law, the prescription must give specific design characteristics under that person's responsibility, and the device must be intended solely for one particular patient to meet that patient's individual conditions and needs.

Annex XIII uses broader statement wording: it asks the manufacturer to identify the particular patient or user by name, acronym, or numerical code. That statement field does not remove the patient-specific test in Article 2(3), so a manufacturer should not treat ordinary user customization as enough for custom-made status.

The exclusion matters: a mass-produced device that is only adapted to a professional user's requirements is not a custom-made device. A device mass-produced by industrial manufacturing processes under written prescriptions is also outside the custom-made definition.

Before placing a custom-made device on the market, the manufacturer must follow Annex XIII and draw up the required statement. Article 21 also requires the device to be accompanied by that statement, made available to the identified patient or user.

Annex XIII requires documentation that lets competent authorities understand the design, manufacture, and performance of the device, including expected performance, so they can assess conformity. The manufacturer must keep the statement for at least 10 years after placing the device on the market, or at least 15 years for implantable devices.

Custom-made devices do not follow the standard class I, IIa, IIb, or III conformity assessment routes used for non-custom-made devices. Article 52(8) points custom-made-device manufacturers to Annex XIII and the Annex XIII statement before placing the device on the market.

There is an added rule for class III custom-made implantable devices: in addition to Annex XIII, the manufacturer must undergo a conformity assessment under Chapter I of Annex IX or may choose Part A of Annex XI.

Annex XIII requires the manufacturer to review and document post-production experience, including PMCF where applicable, and to apply necessary corrective action. Serious incidents and field safety corrective actions must be reported under Article 87 when the manufacturer learns of them.

For class IIa, IIb, and III custom-made devices, Article 86 and MDCG 2022-21 treat the PSUR as part of the Annex XIII documentation. MDCG 2022-21 also states that custom-made-device PSURs may cover device groups or families if the manufacturer justifies the grouping.

For an MDR legacy device, MDCG 2020-3 Rev.1 frames the test around two questions: does the change concern design or intended purpose, and if so is it significant under Article 120(3c), point (b). A significant design or intended-purpose change prevents continued placing on the market under the AIMDD/MDD transition route for that changed device; the manufacturer would need to place the changed device under the MDR route instead.

This screening does not extend the transition period. Eligible class III and certain class IIb implantable legacy devices can use Article 120 only until 31 December 2027, while other covered class IIb, class IIa, and relevant class I sterile or measuring devices can use it only until 31 December 2028, and only while every applicable transition condition remains satisfied.

Screen intended-purpose changes, design or performance specification changes, software changes, substance and material changes, and sterilisation or sterile-packaging changes. Administrative changes, manufacturing-site moves, supplier changes that keep the same specification, and some QMS or process changes may be outside design or intended purpose, but they still need documentation and any agreed notified-body notification.

MDCG 2020-3 Rev.1 says new AIMDD/MDD certificates are not issued under the transition route. For non-significant changes, the certificate should not be amended, but the notified body may provide written confirmation that the proposed change is not a significant design or intended-purpose change and that the related certificate remains valid if the Article 120 conditions are met.

Regulation (EU) 2023/607 also ties the transition route to continued compliance with AIMDD/MDD, absence of significant design or intended-purpose changes, no unacceptable risk, a QMS under MDR Article 10(9), formal MDR conformity-assessment application, written agreement with a notified body, and transfer or continuation of appropriate surveillance as applicable.

Retain enough evidence for a competent authority, notified body, or decision owner to see the exact change, the pre-change certified state, the Article 120 or MDR provision applied, and why the conclusion follows. MDR Article 10 also requires manufacturers to keep technical documentation up to date and to retain technical documentation, declarations of conformity, and relevant certificates for the required retention period.

For clinical and technical impact, update the technical documentation, risk management file, clinical evaluation or PMCF rationale, verification and validation evidence, usability evidence, supplier/material specifications, sterilisation validation, labels and IFU, PMS or vigilance inputs, and QMS change-control records as applicable.

First check whether the device is implantable. Article 2(5) covers a device intended to be introduced completely into the body, or to replace an epithelial surface or the surface of the eye, by clinical intervention and remain after the procedure. It also covers a device introduced partially by clinical intervention that is intended to remain for at least 30 days. Implantable devices can be class IIa, IIb, or III, and all three groups need an SSCP.

If the device is not implantable, check whether it is class III. The manufacturer classifies the device from its intended purpose and the rules in Annex VIII. When several rules or sub-rules apply, the one producing the highest class controls. The technical documentation must record the selected rule and the reason it applies.

Class III routes include certain devices used in direct contact with the heart, central circulatory system, or central nervous system; active implants and devices that control or monitor them; breast implants and surgical meshes; total or partial joint replacements; spinal disc replacements and implants that contact the spinal column; diagnostic or therapeutic decision software whose output could lead to death or irreversible deterioration; devices that incorporate a medicinal substance with an ancillary action; certain tissue-derived, nanomaterial, and systemically absorbed substance-based devices; and active therapeutic devices such as closed-loop systems or automated external defibrillators. Annex VIII contains the complete rules.

Examples in MDCG classification guidance include prosthetic heart valves, vascular stents, cochlear implants and their accessories, breast implants, surgical meshes, total or partial joint replacements, software used to make treatment decisions for acute stroke, antibiotic bone cement, automated external defibrillators, and automated closed-loop insulin-delivery systems. Classification still depends on the intended purpose and applicable rule for the specific device.

Under Rule 8, some ancillary joint or spinal components, including certain screws, wedges, plates, and instruments, remain outside class III. The component still needs an SSCP if it meets the definition of an implantable device.

The SSCP gives the public an updated summary of the device's clinical data, safety, and clinical performance. The instructions for use, implant card, and advice from a healthcare professional remain separate, and the SSCP must be free of promotional claims.

Work through the trigger in order. Start with the Article 2(5) implantable-device definition because an implantable class IIa or IIb device still needs an SSCP. If the device is not implantable, apply every relevant Annex VIII rule and use the highest resulting class. Then check whether the device is custom-made or investigational, because Article 32 excludes both.

Classify from the intended purpose and device characteristics, then record the duration of use, invasiveness, anatomical site, active or software function, materials, and every rule considered. The worked cases show the reasoning pattern. The manufacturer still needs a device-specific classification rationale.

Use controlled technical documentation for every SSCP statement. MDCG 2019-9 Rev.1 organises the public summary around the content groups below. Keep the wording objective and understandable to the intended user, and leave out promotional claims.

The MDR does not assign a permanent class to a product name. The manufacturer applies Annex VIII to the device's intended purpose, duration of use, invasiveness, anatomy, materials, software impact, and other characteristics. The examples below show common classifications from MDCG 2021-24 Rev.1; a specific device may classify differently when its intended purpose or characteristics differ.

For this SSCP question, class I devices are outside Article 32. Class IIa and IIb devices need an SSCP only when they meet the definition of an implantable device. Every class III device needs an SSCP, whether implantable or not, unless it is custom-made or investigational.

Source the SSCP from the device's technical documentation: the controlled evidence set that shows how the device meets the MDR. Keep a traceable record showing the source for each public statement and confirming that it still matches the current technical documentation.

For the clinical section, retain the clinical evaluation plan and report, the evidence used to support conformity, both favourable and unfavourable clinical data, and the post-market clinical follow-up (PMCF) plan and evaluation report. If the clinical evaluation relies on equivalence to another device, retain the equivalence rationale and evidence showing that the manufacturer has sufficient access to the equivalent device's data.

Sorena AI assembled this page from Regulation (EU) 2017/745, MDCG 2019-9 Rev.1, MDCG 2021-24 Rev.1, MDCG 2026-4, and the European Commission's EUDAMED overview. Each statement about eligibility, classification, content, evidence, publication, and updates was mapped to those sources. Repeated explanations were combined into standalone answers and worked cases.

AI assisted with source comparison, drafting, and organisation. Readers can use the citations to check each conclusion against the controlling regulation and current Commission guidance. No named human regulatory or clinical reviewer is claimed. For a specific device, confirm the intended purpose, classification rationale, notified-body instructions, applicable Member State language requirements, and current EUDAMED process before acting.

Source review current as of 23 July 2026. This revision added the standalone decision test, class-based worked cases, a scannable SSCP content checklist, translation and lifecycle answers, internal reading paths, and the June 2026 EUDAMED transition guidance. The page date reflects those substantive changes.

The manufacturer decides the Basic UDI-DI grouping from its technical knowledge and the issuing entity's rules. Group only devices that share the same intended purpose, risk class, and essential design and manufacturing characteristics. The Basic UDI-DI is the main database and documentation key; it appears in the EU declaration of conformity and, where applicable, product certificates, technical documentation, the summary of safety and clinical performance (SSCP), and the periodic safety update report (PSUR). It is not placed on the device label.

Assign a UDI-DI to the device model and a separate UDI-DI to each higher packaging level, excluding shipping containers. The UDI-DI is specific to a manufacturer and device. It combines with the production identifier, or UDI-PI, to form the UDI conveyed by the UDI carrier. A Basic UDI-DI may link to one or more UDI-DIs, but each device UDI-DI links to one Basic UDI-DI in EUDAMED.

The UDI carrier is the AIDC and HRI representation of the UDI. As a general rule, it is placed on the label or device itself and on higher packaging levels. Annex VI contains exceptions for space constraints, certain individually packaged class I and IIa single-use devices, retail point-of-sale packaging, direct marking, and systems or procedure packs. The UDI requirement does not replace the rest of the MDR labelling requirements.

Manufacturers must submit UDI/device information in EUDAMED for devices subject to the registration requirements. The UDI/Devices module has been mandatory since 28 May 2026. Before placing a device other than a custom-made device on the market, the manufacturer must enter or verify the applicable Annex VI device information and keep it updated. A UDI-DI record does not prove that the device conforms to the MDR.