Complete UDI implementation, from coding to regulatory submission.

Why now?

UDI has moved from a trend to a requirement

The staggered deadlines under RDC 591/2021 are already in force by risk class, and the FDA and European Union have required UDI for years. Without compliance, the product cannot circulate.

ANVISA

RDC 591/2021

• Staggered deadlines by risk class
• Data in the ANVISA system

DeadlineThe current timetable for each class is confirmed during the initial assessment.

United States

21 CFR Part 830

• Mandatory submission to GUDID
• Established requirement across all classes

DeadlineThe requirement is already in force across all classes.

European Union

MDR 2017/745

• Basic UDI-DI
• EUDAMED registration

DeadlineStaggered obligations by class under the MDR.

Service scope

Everything your company needs to implement UDI, in one project

1. 01

   Initial assessment and gap analysis

   Portfolio assessment, risk classification and mapping of applicable requirements by market and class.

2. 02

   Coding strategy

   Defining the issuing agency, UDI-DI and UDI-PI architecture by product family, and the approach for kits, configurable devices and software (SaMD).

3. 03

   Labelling compliance

   Marking requirements for the label and the device itself (direct marking where applicable), AIDC and HRI formats, and artwork review.

4. 04

   Data structuring

   Preparing the data attributes required by each regulatory database, consistency validation and information governance.

5. 05

   Regulatory submission

   Registration and submission to ANVISA, GUDID (FDA) and EUDAMED (EU), including account and credential management.

6. 06

   QMS integration

   UDI procedures incorporated into the quality management system (ISO 13485), change control and ongoing record maintenance.

Frequently asked questions

Your UDI questions

• 01My company is an importer. Is UDI my responsibility or the manufacturer's?

  Responsibility rests with the product's registration holder in the country. An importer holding the registration assumes the UDI obligation even when manufacturing takes place overseas. Our initial assessment maps responsibility for each product in your portfolio.

• 02Which ANVISA risk classes already have applicable deadlines?

  The deadlines under RDC 591/2021 are staggered by risk class and have been implemented progressively. As the timetable has been adjusted, we confirm the current position for your class during the assessment, so you do not work with outdated dates.

• 03Do I have to use GS1?

  No. GS1 is one of the accredited issuing agencies, but not the only one: HIBCC and ICCBBA are also recognised. Agency selection forms part of the coding strategy and depends on your portfolio and target markets.

• 04Does Software as a Medical Device (SaMD) also require UDI?

  Yes. SaMD is subject to UDI, with specific rules on assigning and presenting the identifier. We address this case specifically within the coding strategy.

• 05I already have UDI for the FDA. Does it apply to ANVISA?

  The coding work already completed can be reused, but each regulatory database has its own data attributes and submission requirements. A UDI in GUDID does not replace ANVISA registration. We reuse what exists and complete what each market still requires.

• 06How long does complete implementation take?

  It depends on the portfolio's size and complexity and the number of markets involved. The initial assessment establishes a realistic timetable by risk class, prioritising the nearest deadlines.