In-House / Custom-Made Devices | MedTech Compliance Guide

EU requirements

Classification: Custom-made devices follow a distinct MDR Annex XIII procedure rather than standard CE-marking and conformity assessment. Devices manufactured and used within a health institution have a narrower Article 5(5) exemption subject to strict conditions.
Conformity pathway: There is no standard CE-marking or Notified Body route for a compliant custom-made device. The manufacturer issues an Annex XIII section 1 statement and retains documentation under section 2 for at least 10 years, or 15 years for implantable devices.

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01Confirm custom-made status under Article 2(3) versus in-house status under Article 5(5).Source: MDR Annex XIII
02Draft the Annex XIII statement with patient or prescriber identification and GSPR conformity.Source: MDR Annex XIII
03Maintain documentation under Annex XIII section 2.Source: MDR Annex XIII
04Retain the statement for at least 10 years, or 15 years if implantable.Source: MDR Annex XIII
05Implement PMS and PMCF review and report serious incidents and FSCAs.
06For in-house devices, verify every Article 5(5) condition.

Classification: The Custom Device Exemption under FD&C Act section 520(b) may apply regardless of class when all eligibility criteria are met.
Conformity pathway: A qualifying custom device is exempt from premarket requirements, subject to conditions including a limit of five units per year of each device type and a Custom Device Annual Report.

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01Confirm Section 520(b) eligibility, including a patient-specific need and no generally available substantial equivalent.Source: FDA Custom Device Exemption Guidance
02Track production against the five-units-per-year, per-device-type limit.Source: FDA Custom Device Exemption Guidance
03Prepare and submit the Custom Device Annual Report.Source: FDA Custom Device Exemption Guidance
04Maintain complaint files.
05Document the design and manufacturing rationale supporting the exemption.