MDCG 2021-19: UDI integration within the quality management system, explained

Who this applies to

MDCG 2021-19 is for manufacturers and other operators that assume manufacturer obligations under the MDR or IVDR. Its central point is simple: assigning a code is only one part of UDI compliance. The organisation must verify assignments and keep UDI data valid and consistent across products, labels, records and EUDAMED.

That work belongs in the QMS because UDI decisions affect design, regulatory documentation, production, suppliers, post-market surveillance and vigilance.

Establish governance before assigning identifiers

Create a UDI implementation plan that covers:

• applicable legal and stakeholder requirements;
• the rules of the chosen EU-designated issuing entity;
• named internal owners and interfaces between regulatory, quality, engineering, operations and IT;
• external responsibilities for suppliers, authorised representatives, importers and distributors;
• implementation milestones and controlled updates; and
• methods for verifying continued compliance.

Define who approves Basic UDI-DI groupings, creates UDI-DIs, selects UDI-PIs, controls master data, releases labels and submits changes to EUDAMED. Avoid leaving different systems with different unnamed owners.

Cover the full operational chain

When an identifier changes, retain the previous UDI in the appropriate quality records. That historical link is particularly important for relabelled or repackaged devices.

Validate the tools that carry UDI data

Label printing should be verified and validated, and printing equipment maintained. Barcode scanners and verification methods should confirm that the human-readable and machine-readable forms encode the intended identifier.

Software used for label generation, identifier management or machine-to-machine EUDAMED upload should be validated for its intended use. Changes to those validated processes and systems need an impact assessment. Vendor ownership of a tool does not transfer the manufacturer's responsibility for the resulting data.

What this means for you, practically

The Basic UDI-DI, UDI-DI and UDI-PI serve different purposes, but the relationships between them must remain controlled. Product master data should also agree with declarations, certificates, technical documentation, labels, packaging and EUDAMED.

A useful release gate verifies:

1. the Basic UDI-DI grouping and UDI-DI decision;
2. applicable packaging-level and direct-marking requirements;
3. label content and barcode quality;
4. links to production and post-market records;
5. EUDAMED data and update responsibility; and
6. retained evidence of review, approval and training.

Use MDCG 2018-1 for the core grouping and UDI-DI change rules, MDCG 2018-5 for software releases and MDCG 2022-7 for specific UDI questions.

Read the official MDCG 2021-19 guidance.