ISO 13485 · Expert · 14 min lesson
Auditing UDI, EUDAMED, labelling and economic operators (MDR Articles 13 to 16 and 27 to 33)
EU MDR 2017/745 Articles 13, 14, 16, 27 to 31 and 33, Annex I chapter III section 23, Annex VI Part C; Implementing Regulation (EU) 2021/2226
What you will learn
- Audit UDI assignment, UDI carriers and the matching device record in the database.
- Audit importer and distributor duties, contracts and records under Articles 13, 14 and 16.
- Check labelling and instructions for use against Annex I chapter III and write a graded finding.
Key takeaways
- The unique device identifier is built under Article 27 and the label, ERP record and database record must agree character by character.
- Article 29 requires the Basic UDI-DI and core data in the database; the first four EUDAMED modules have been mandatory since 28 May 2026.
- Importers (Article 13) verify before placing; distributors (Article 14) check before making available; both forward complaints immediately.
- Article 16 moves manufacturer duties to anyone who markets under its own name, changes the intended purpose or modifies the device.
- Labels and instructions follow Annex I section 23; electronic instructions need the conditions of Implementing Regulation 2021/2226.
Free practice question
Halden Surgical changes the carton for HS-DRN-01 and the label printer produces a new UDI-DI. The regulatory team has not updated the registered record and no change request exists.
What is the audit conclusion?
No finding, because the database can be updated whenever convenient.
Not quite. Article 29 expects the data in the database to be correct when the device is placed on the market.
Observation, because the barcode scans correctly at the factory.
Not quite. A scan only shows readability and does not prove that the label equals the registered record under Article 27.
Nonconformity: label and registered record disagree and change control has not captured the change.
Correct. Articles 27 and 29 require consistent identifier data, and ISO 13485 clause 7.3.9 requires controlled design changes.
Nonconformity for the importer only.
Not quite. The manufacturer assigns the identifier and supplies the data under Articles 27 and 29, so the cause lies with it.
Key terms
- UDI-DI: The fixed part of the unique device identifier that identifies a device model and packaging level (Article 27, Annex VI Part C).
- UDI-PI: The variable part of the identifier, such as lot, serial number or dates (Annex VI Part C).
- Basic UDI-DI: The main key of a device group in the database, shown on certificates and the declaration of conformity (Article 29).
- EUDAMED: The European database on medical devices described in Article 33, including actor, UDI and device, certificate and market surveillance modules.
- importer: An economic operator in the Union that places a device from a third country on the market (Article 13).
- distributor: A person in the supply chain, other than manufacturer or importer, who makes a device available on the market (Article 14).
- eIFU: Instructions for use supplied in electronic form under Implementing Regulation (EU) 2021/2226.
Official sources
- Regulation (EU) 2017/745 on medical devices (EUR-Lex)
- Commission Implementing Regulation (EU) 2021/2226 on electronic instructions for use of medical devices (EUR-Lex)
- European Commission: UDI and device registration in EUDAMED
- BASG: mandatory use of the first four EUDAMED modules (notice on Decision (EU) 2025/2371)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.