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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 for one particular patient or user.

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 MDR legacy devices, 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.

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.

Assign the Basic UDI-DI at the device model grouping level. It is the main key for records in the UDI database and is referenced in documents such as product certificates, EU declarations of conformity, technical documentation, and, where relevant, SSCP or PSUR materials.

Assign the UDI-DI at the device and packaging level. It is specific to a manufacturer and device model, is unique at each level of device packaging, and works with the UDI-PI to form the UDI conveyed by the UDI carrier.

The UDI carrier is the label or device marking mechanism that conveys the UDI, normally through AIDC and, where applicable, human-readable interpretation. It is an additional UDI requirement and does not supersede other MDR labelling requirements.

EUDAMED is the registration destination for UDI/device information. The Commission UDI/device registration page states that manufacturers must submit UDI/device information in EUDAMED for devices they place on the EU market and points to data sets covering MDR UDI and device data.

A new UDI-DI is required when a change could lead to misidentification of the device or ambiguity in traceability. MDCG 2022-7 repeats the MDR Annex VI examples and gives practical examples for package quantity and substance-based devices.

The clearest triggers include changes to the name or trade name, device version or model, single-use status, sterile packaging status, need for sterilisation before use, package quantity, or critical warnings and contraindications such as latex or DEHP.

Keep a record that links the identifier to the product facts that justified it. The useful record is not just the code; it is the grouping rationale, issuing entity rule, packaging level, label or carrier evidence, EUDAMED submission data, and any change assessment that explains why the identifier stayed the same or changed.

For reprocessing and relabelling situations, keep traceability back to the original device identifier where the guidance or MDR rule calls for it. MDCG 2022-7 says a reprocessor who becomes the manufacturer should keep the original product UDI in technical documentation and the QMS, and MDR Annex VI requires manufacturers that relabel or repackage devices with their own label to retain the original manufacturer's UDI.

PMCF is a continuous process that updates the clinical evaluation under Article 61 and Annex XIV, Part B. It must be addressed in the manufacturer's PMS plan and performed under a documented PMCF plan.

The plan should identify the device and covered variants, intended purpose, users, patient population, indications, contraindications, warnings, classification, expected lifetime, and the PMCF objectives for that device. It should also reference the clinical evaluation report and risk management file so the post-market clinical questions being followed are clear.

Keep evidence showing that PMCF was planned, performed, analysed, and used to update the device file. The retained record should let a reviewer trace each PMCF activity from the clinical question or risk being monitored to the data source, method, result, conclusion, and follow-up action.

The PMCF evaluation report becomes part of the clinical evaluation report and technical documentation. PMCF conclusions must be considered in the clinical evaluation and risk management; where PMCF identifies a need for preventive or corrective measures, the manufacturer must implement them.

Start with the intended purpose as stated in labels, instructions for use, advertising, clinical documentation, and software release material. MDR classification is based on intended purpose and inherent risk, and Annex VIII applies the strictest applicable rule when more than one rule fits the device.

Treat the reassessment as a conformity-route question, not just a label update. Moving from class I self-declaration into class Is, Im, Ir, IIa, IIb, or III can add notified-body involvement; moving between higher classes can change the depth of technical documentation, clinical evaluation, certificate scope, and surveillance expectations.

For software, reassess the medical purpose, the information the software provides, the clinical decision it supports, the user population and setting, and whether the software drives or influences another device. A change in algorithm, output, indication, user group, integration, or risk-control logic can change the Annex VIII analysis.

The evidence file should let a reviewer see why the old class is still valid or why the device needs a new conformity route. Keep the classification rationale with the technical documentation rather than as a separate project note.

Where a notified body is involved, retain the submission, questions, decisions, certificate supplement or new-certificate path, and any surveillance-transfer or transitional-provision correspondence. Where the conclusion is that no class change occurred, retain the negative analysis and the facts that made the change non-significant or outside the rule change.

The MDR allows a clinical evaluation to rely on clinical data for another device only where equivalence to the device under evaluation can be demonstrated. This is not a shortcut around clinical evaluation: the clinical evaluation still has to be planned, continuously conducted, documented, and supported by a clinical evaluation report.

The equivalence argument has to cover technical, biological, and clinical characteristics. The comparison should identify differences, explain why they are not clinically significant for safety or clinical performance, and point to the underlying data rather than relying on a shared product category or broad similarity claim.

For implantable devices and class III devices, MDR equivalence is more constrained. MDCG 2020-5 explains that clinical investigations are generally expected unless the device is a modification of a device already marketed by the same manufacturer and equivalence is demonstrated under the MDR.

Where a manufacturer of an implantable or class III device claims equivalence to a device from another manufacturer, MDCG 2020-5 identifies the MDR contract requirement: the manufacturer needs full access to the technical documentation on an ongoing basis. The guidance also notes that this means relying on a device certified only under the old directives will not be possible for that route.

Equivalence evidence should remain connected to the clinical evaluation and PMCF plan. MDR Annex XIV treats PMCF as the continuous process that updates the clinical evaluation, confirms safety and performance over the device lifetime, checks the benefit-risk ratio, and detects emerging risks on factual evidence.

Equivalent or similar devices may also matter after market entry, but not as a substitute for data on the device under evaluation. PMCF should identify which equivalent or similar-device data will be monitored, why it is relevant, and how new findings will update the clinical evaluation, risk management, or corrective actions.

Retain a reviewer-ready record showing which device was assessed, which presumed equivalent device was used, what data were available, and why the manufacturer concluded that the MDR equivalence criteria were met. The record should sit with the clinical evaluation report and technical documentation, not in an informal rationale detached from the conformity-assessment file.

The strongest evidence package is a structured equivalence table with device-by-device comparisons, data references, identified differences, scientific justifications, and conclusions on whether any difference is clinically significant.

A product, including software, is within the MDR device definition when the manufacturer intends it to be used for one or more MDR medical purposes for human beings. Core medical-purpose language includes diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease, injury, or disability; investigation, replacement, or modification of anatomy or a physiological or pathological process or state; and certain in vitro information uses.

The MDR does not limit intended purpose to a single formal statement. It is read from data supplied by the manufacturer on the label, instructions for use, promotional or sales materials or statements, and as specified in the clinical evaluation. Advertising and product claims also matter because Article 7 prohibits claims that mislead users or patients about intended purpose, safety, or performance.