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FAQEU MDR

Custom-made devices under the EU MDR

EU MDR custom-made status requires a device made for one particular patient under an authorised person's written prescription with specific design characteristics; ordinary made-to-order products do not qualify.

This FAQ helps separate true custom-made devices from mass-produced adaptable devices and to retain the Annex XIII statement, conformity, PMS, vigilance, and manufacturing evidence.

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Author
Sorena AI
Published
May 9, 2026
Updated
Jul 24, 2026
Questions
4

Structured answer sets in this page tree.

Primary sources
3

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 24, 2026
Overview

Under the EU MDR, a is specifically made under a written prescription for the sole use of a particular patient to meet individual conditions and needs. Mass-produced devices adapted for a professional user, or mass-produced through industrial manufacturing processes under prescriptions, are not custom-made devices.

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4 of 4 questions
Question 1

What counts as a custom-made device under the EU MDR?

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 . A device mass-produced by industrial manufacturing processes under written prescriptions is also outside the custom-made definition.

  • Keep the prescription and evidence that the prescriber was authorised under national law.
  • Identify the patient or user by name, acronym, or numerical code in the .
  • Record why the device is not a mass-produced adaptable device or an industrially mass-produced prescription device.

What evidence is needed for custom-made medical devices under the EU MDR?

Keep the written prescription, authorised prescriber details, patient or user identifier, device identification data, , design and manufacturing documentation, GSPR conformity rationale, manufacturing controls, PMS or PSUR records where applicable, vigilance reports, and corrective-action records.

Are mass-produced adaptable devices custom-made devices under the EU MDR?

No. The MDR definition excludes mass-produced devices adapted to a professional user's requirements and devices mass-produced by industrial processes in accordance with authorised written prescriptions.

Citations
Question 2

What statement and documentation must the manufacturer keep?

Before placing a 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.

  • Retain manufacturer and manufacturing-site details, authorised representative details where applicable, and device identification data.
  • Include the prescription-specific characteristics, the authorised prescriber and health institution where applicable, and the identified patient or user.
  • State conformity with Annex I general safety and performance requirements, and explain any requirements not fully met.
Citations
Question 3

How is conformity assessment different?

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 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.

  • Do not use the custom-made route for ordinary configurable or adaptable catalogue devices.
  • Confirm whether the device is class III and implantable before deciding whether notified-body conformity assessment is required.
  • Keep the route decision with the prescription, classification rationale, , and manufacturing documentation.
Citations
Question 4

What PMS and vigilance evidence should be retained?

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.

  • Retain complaint, incident, field safety corrective action, PMCF, corrective-action, and benefit-risk review records.
  • For class IIa, IIb, and III custom-made devices, keep the PSUR with the Annex XIII documentation and justify any grouped PSUR family.
  • Link PMS conclusions back to the prescription characteristics, design rationale, risk management file, and manufacturing controls.
Citations
Recommended next step

Review your custom-made-device evidence pack

Check whether the device is truly custom-made, then keep the prescription, Annex XIII statement, design and manufacturing rationale, PMS, vigilance, and corrective-action records together.

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Talk through implementation

Review your device facts, Annex XIII statement, conformity route, and PMS records.

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Primary sources

References and citations

Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu
Referenced sections
  • Articles 83 to 87 and Annex XIII support PMS, PSUR, PMCF, vigilance, serious-incident, and field-safety-corrective-action evidence for custom-made devices.
"review and document experience gained in the post-production phase"
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