EUDAMED Manager Formfield Mapping Guide

This manual explains which formfields from which meddevo collections appear in the EUDAMED Manager and how values are populated and exported to EUDAMED. Use it to quickly answer: “Where does EUDAMED get this value from in meddevo?”

Scope and prerequisites

• The starting point is always a Product entry in the products collection.
• Ensure the product is linked to:
• • A Basic UDI-DI (if applicable)
  • One or more UDI-DIs
  • A Product Group (for the device/model name)
  • Legal Manufacturer (for SRN)
  • Countries (for market info)
  • Critical Warnings (if used)
  • Medicinal Purpose (SPP only)

How the Manager assembles data

• The EUDAMED Manager reads the Product and follows its reference/connection formfields into related collections.
• Choice values are translated to EUDAMED codes (e.g., risk class, UDI status, UDI-PI type, issuing entity).
• Multilingual text is exported per language; HTML is stripped.
• Countries are resolved to EUDAMED-compatible ISO codes via the Countries & Regions collection.

How to read the mapping tables

• EUDAMED field and EUDAMED ID: the name and identifier used by EUDAMED.
• meddevo collection: where the value lives.
• Formfield (label) and Formfield (system name): the human-readable label may be customized per workspace; the system name is stable. When in doubt, match on the system name.

Collections that feed EUDAMED

Basic UDI-DI

UDI-DI (from the UDI-DI record)

UDI-DI (from the Product record)

Rules, fallbacks, and defaults

• Issuing Entity: defaults to GS1 when empty (both Basic UDI-DI and UDI-DI).
• Risk Class: if not set on Basic UDI-DI, falls back to the Product’s class; if still not available, Class I is used for MDR devices (IVDR and legacy follow analogous logic).
• Quantity per package: defaults to 1 if empty or not a positive number.
• Product/Trade name: multilingual; empty languages are dropped.
• Additional description: HTML is stripped before export.
• Countries: selections are resolved to EUDAMED ISO codes via Countries & Regions.
• First placed on the market: is flagged as “originally placed”; if missing from the marketed list, it is prepended.

Choosing the primary UDI-DI

• The record whose UDI-DI Type includes “Primary” is the primary device identifier.
• Direct Marking is never promoted to Primary; it is exported as the device marking.
• All other linked UDI-DIs become packaging levels following the “Consisting of” chain.
• If no qualifying Primary exists, the product is skipped and listed in the report.

Value translations

• meddevo translates choice values to EUDAMED codes, including:
• • Risk class (MDR/IVDR)
  • UDI status (On the market, No longer placed on the market, Not intended for the EU market)
  • Issuing entity (GS1, IFA, HIBCC, ICCBBA, EUDAMED for legacy)
  • Type of UDI-PI (Batch, Serial, Expiration date, Manufacturing date, Software identification)

Locked after registration (change control)

• Changing these requires a new Basic UDI-DI:
• • Risk class
  • SPP type
  • All Basic UDI-DI characteristics (tissues/cells, active, implantable, measuring function, reusable surgical instrument, software, and IVD flags)
• Changing these requires a new UDI-DI:
• • Reference/Catalogue number
  • Quantity per package
  • Sterile/Need for sterilisation
  • Latex
  • Reprocessed single-use
  • Labelled as single use
  • Maximum number of reuses
  • Clinical sizes
• Conditionally locked: Unit of Use UDI-DI, Direct Marking UDI-DI, Secondary UDI-DI.

Known gaps (maintain directly in EUDAMED)

• Suture/Staple/Dental filling/Brace (MDR) — FLD-UDID-265
• Tissues/cells of microbial origin (IVD) — FLD-UDID-34
• Device certificate information attached at registration — FLD-UDID-39
• Authorised Representative comments — FLD-UDID-37
• Intended purpose other than medical (Annex XVI) — FLD-UDID-147
• Secondary UDI-DI — FLD-UDID-293
• Reagent/Instrument — FLD-UDID-262 / FLD-UDID-264 (read back for comparison only)

Legacy device limitations

• IVDD risk class: no dedicated Product formfield; IVDD devices lack a class to send and are skipped.
• AIMDD discriminator: no separate flag from MDD; applicable legislation for legacy active implantables cannot be determined.

Pre-submission checklist

• Product has:
• • Linked Basic UDI-DI (if applicable) and at least one UDI-DI marked as Primary
  • Linked Product Group (for the device/model name)
  • Legal Manufacturer contact with SRN
  • Countries set (marketed and “first placed on the market”)
• UDI-DI statuses use EUDAMED wording or recognized defaults.
• Clinical Sizes rows are complete per their precision (value/range/text).
• No HTML remains in rich text formfields you expect to export.

Troubleshooting common issues

• Missing primary UDI-DI: ensure at least one UDI-DI Type includes “Primary”.
• Invalid UDI status blocks export: use recognized values (On the market, No longer placed on the market, Not intended for the EU market).
• Clinical size not appearing: the row is incomplete for its chosen precision; fill required columns or remove the row.
• Device/model name incorrect: update the linked Product Group name (the Product name is not used for FLD-UDID-22).
• Issuing Entity empty: defaults to GS1; set explicitly if you need another agency.

Getting support

If a value appears in EUDAMED differently than this guide describes, contact support and include:

• Product Code
• EUDAMED field ID (FLD-UDID-…)
• meddevo formfield system name
• A brief description and, if possible, a screenshot of the relevant meddevo form section.