PIM for Medical Devices and Pharma: MDR, UDI and EUDAMED Product Data (2026)

Last updated: 3 November 2026.

A medical device manufacturer that wants its PIM to carry UDI data all the way to EUDAMED and the FDA's GUDID should look first at Innovit, Informatica Product 360 with the BYRD Health accelerator, and Syndigo, because they document UDI submission on their own pages. Stibo Systems fits an enterprise that wants governed UDI-DI and Basic UDI-DI relationships in its master data and leaves the submission to a regulatory system. Sales Layer, Pimcore, Viamedici and Akeneo fit when a regulatory information management (RIM) tool already submits and the PIM's job is product content, instructions for use per market, catalogs and distributor feeds.

The vendor is the second decision. The first is which system owns which data. Medtech answers often mix quality management, PLM and regulatory tools into a PIM question, and that is where projects go wrong: two systems both think they own the UDI-DI, or nobody owns the IFU link per language. This page sets out what MDR, IVDR and UDI ask for, which system usually owns each kind of data, how the data reaches EUDAMED and GUDID, and which PIM vendors document medtech features. For the general market, see the best PIM software.

Which PIM fits a medical device or pharma manufacturer?

Start from your regulatory setup, not from the PIM feature list. Three situations cover most manufacturers:

1. No dedicated UDI or RIM tool yet. You need a product data platform that holds UDI attributes per packaging level, validates them against EUDAMED and GUDID rules and submits them, or one that comes with a UDI submission module. Innovit, Syndigo and Informatica Product 360 with BYRD Health document that.
2. A RIM or UDI tool already submits. The PIM then supplies device descriptions, translations, images and IFU links, and takes the identifiers from the regulatory system. Stibo Systems, Sales Layer, Pimcore, Viamedici and Akeneo can all play that role; they differ in how much governance and medtech modeling they document.
3. Pharma. Medicinal product data for regulators follows the IDMP standards and lives in regulatory systems. The PIM serves commercial content to pharmacies, wholesalers and webshops.

In each case the PIM needs an audit trail and approval steps strong enough for your quality team, because a wrong contraindication in a webshop can turn into a labelling issue, not just a typo. Our requirements checklist for B2B PIM covers the general requirements; this page adds the medtech ones.

Which product data do MDR, IVDR and UDI require?

The EU Medical Device Regulation, Regulation (EU) 2017/745, and the In Vitro Diagnostic Medical Devices Regulation, Regulation (EU) 2017/746, introduce a Unique Device Identification (UDI) system for medical devices. According to the Medical Device Coordination Group's guidance MDCG 2018-1 Rev.4 (April 2021), the main UDI provisions sit in Chapter III and Annex VI of both regulations. The Commission's new regulations page states that the IVDR has applied in the EU since 26 May 2022.

The building blocks, as the Commission's UDI page describes them:

Element	What it is	Where it lives	What it means for product data
UDI-DI	Device identifier, specific to a manufacturer and a device, giving access to device information	In the UDI on the label and on every higher packaging level	One per device model and packaging level; an attribute your product model must hold per pack
UDI-PI	Production identifier for the unit of production, such as lot or serial number, expiry or manufacturing date	In the UDI on the label, generated in production	Comes from production and ERP, not from the PIM
Basic UDI-DI	Main key in the UDI database and in certificates, the declaration of conformity and technical documentation	In EUDAMED and regulatory documents; it does not appear on any trade item	Groups devices with the same intended purpose, risk class and essential design and manufacturing characteristics; each UDI-DI links to exactly one Basic UDI-DI
UDI/device registration	The device data set a manufacturer submits for each device placed on the EU market	EUDAMED, UDI/Devices module	Must use the European Medical Device Nomenclature (EMDN)
Label and IFU	The labelling and instructions for use the regulations require	On the device, the packaging and in the IFU	The UDI adds to labelling requirements and does not replace them

Three details matter for a PIM data model. First, MDCG 2018-1 lists changes that require a new UDI-DI: name or trade name, device version or model, labelled as single use, packaged sterile, need for sterilization before use, quantity of devices in a package, critical warnings or contraindications (for example latex or DEHP), and CMR or endocrine disruptor substances. A PIM that lets someone edit those attributes on an existing UDI-DI without a check creates a compliance problem. Second, the same guidance notes that where a manufacturer establishes a maximum number of reuses, Annex VI Part B requires it in the UDI database and it must also appear in the instructions for use. Third, the UDI page states that manufacturers assign the UDI to the device and all higher packaging levels before placing it on the market, so your packaging hierarchy has to be in the data before launch, not after.

Four issuing entities can provide UDIs in the EU: GS1, HIBCC, ICCBBA and IFA, designated under Implementing Decision (EU) 2019/939 and renewed until 27 June 2029 by Implementing Decision (EU) 2024/2120, according to the Commission's UDI page. GS1 publishes its own UDI guidance for healthcare. If your trade items already carry GS1 identifiers, ask your issuing entity early how its keys map to UDI-DI and Basic UDI-DI. Our guide to GS1, ETIM, ECLASS and BMEcat in a PIM explains how a PIM stores standard identifiers and classifications.

In the United States, the FDA's UDI system page (content current as of 22 July 2022) says the UDI rule generally requires device labelers to put a UDI issued under an FDA-accredited issuing agency's system on labels and packages, in some cases directly on the device, and to submit device information to the Global Unique Device Identification Database (GUDID). GUDID holds only the device identifier, with flags showing which production identifiers appear in the UDI, and its public data is searchable through AccessGUDID (page content current as of 17 December 2024).

For pharma, the European Medicines Agency describes ISO IDMP as five ISO standards for identifying medicinal products (ISO 11238, 11239, 11240, 11615 and 11616), implemented by EMA in a phased programme based on four master data domains: substance, product, organisation and referential (SPOR). The data covers product name, ingredient substances, pharmaceutical product, marketing authorisation, clinical particulars, packaging and manufacturing. That is regulatory master data, owned by regulatory affairs.

PIM, PLM, QMS and regulatory software: which system owns which data?

This is where most medtech PIM projects are won or lost. Each system below is the system of record for its own data. The others read it. The split is the common pattern we see, not a legal rule: what matters is that every attribute has one owner, written down.

Data	System of record	What the PIM does with it
Design, bill of materials, engineering changes, device versions	PLM	Takes released versions and technical specifications; never edits them. See PLM and PIM integration
Design history, document control, CAPA, complaints, training records	QMS	Nothing, or a reference such as a document number; quality records do not belong in a PIM
Approved labelling and IFU content, by market and language	QMS document control or RIM, depending on your process	Stores the released IFU file or link per market and language and publishes it to channels; does not approve it
UDI-DI assignment, Basic UDI-DI, EMDN code, risk class, certificates, registrations per market	RIM or a dedicated UDI tool (in some setups, an MDM or PIM with a UDI module)	Holds a read-only copy for channels and feeds, or is the master when its vendor documents UDI governance and submission
EUDAMED and GUDID submissions and their status	RIM, UDI tool or service provider	Supplies attributes to the submitting system
Material number, prices, stock, lots and serial numbers	ERP	Takes article numbers and commercial data; production identifiers stay in ERP and production
Medicinal product data under IDMP (substances, marketing authorisations)	RIM	Takes identifiers for commercial content; does not maintain regulatory master data
Product descriptions, translations, images, marketing claims, catalog and webshop content, distributor and hospital feeds	PIM	Owns it, with approval steps for anything a regulator would read as labelling

Where this goes wrong in practice: the PIM team creates a new pack size as a variant, the quantity per package changes, and nobody tells regulatory affairs that it needs a new UDI-DI. A good setup either blocks that change in the PIM until the regulatory system has issued the identifier, or keeps UDI fields read-only in the PIM altogether. Our page on PDM vs PIM vs DAM covers the engineering to commercial handoff in general, and PIM vs MDM vs DAM vs PXM explains the system categories.

The tools that buyers often meet in this question play these roles, according to their own pages:

Tool	What it is	Is it a PIM?
Greenlight Guru	Quality management system (QMS) for medical devices, plus electronic data capture for clinical studies	No
Propel	PLM and QMS platform for medical devices; it also lists a Propel PIM module, and its medical device page does not mention UDI or EUDAMED	No, it is a PLM and QMS platform
Rimsys	Regulatory information management with UDI management and EUDAMED and GUDID integration	No
Veeva	Quality (QMS, QualityDocs) and regulatory (RIM) software for medtech	No

Greenlight Guru, Propel, Rimsys and Veeva are QMS, PLM or regulatory tools, not PIMs. They can be the right owner for part of the data in the table above. They are not a replacement for a PIM that publishes product content to webshops, distributors and hospital buyers, and a PIM is not a replacement for them.

Does the PIM submit data to EUDAMED or GUDID, or feed the system that does?

In most setups the PIM feeds the system that submits. The EUDAMED Information Centre names three ways to enter data for the actor, UDI/device and certificate modules: manual entry in the user interface, semi-automated XML upload, and machine-to-machine (M2M) data exchange between an external backend system and EUDAMED. It notes that full automation may cost too much when the volume or frequency of submissions is low. GUDID accepts data through its web interface, one device at a time, or as HL7 SPL files through the FDA Electronic Submissions Gateway for bulk submissions, according to the FDA's GUDID page.

What the vendors document, checked on 3 November 2026:

• Submits: Innovit describes M2M submission to GUDID, EUDAMED, ausUDID and swissdamed in HL7 SPL, SOAP XML and other formats, with validation rules per database. Syndigo describes a Global UDI Submission service covering FDA GUDID, EUDAMED and other health authorities. Informatica describes Product 360 with the BYRD Health accelerator to create, maintain and syndicate regulatory data for EUDAMED and GUDID, with submission status dashboards.
• Governs or maps, does not claim to submit: Stibo Systems describes governing the device-family, UDI-DI, Basic UDI-DI, packaging and market relationship data that submissions depend on, and says RIM manages regulatory submissions. Sales Layer describes mapping fields for GUDID or EUDAMED. Pimcore names regulatory bodies (UDI, FDA, EUDAMED) as distribution targets without describing the mechanism.
• Not documented: Viamedici and Akeneo do not mention UDI, EUDAMED or GUDID on the pages we checked.

If your PIM does not submit, budget for one of three routes: a RIM or UDI tool, a service provider, or your own M2M integration. Then make the PIM the source of the commercial attributes and the receiver of the regulatory ones, so data flows one way.

Which PIM vendors serve medtech and pharma?

The table lists PIM, MDM and product data vendors that publish medtech or healthcare material, or that buyers ask about for this segment. It is not a ranking. Every cell comes from the vendor's own page, opened on 3 November 2026; "not documented" means the page we checked does not say it, not that the product cannot do it.

Vendor	Documented medtech features	GS1 or GDSN	Audit trail and approvals	Source
Innovit	UDI submission to GUDID, EUDAMED, ausUDID and swissdamed via M2M; validation rules per database; PIM and MDM in the same suite	GDSN data syndication with connectors for atrify, NPC, GHX and others; pre-configured GS1 attributes	Audit trail and submission history, stated to support 21 CFR Part 11 and Annex 11; flexible approval workflows	UDI compliance, home
Informatica Product 360	With the BYRD Health accelerator: templates aligned to GUDID and EUDAMED, validation rules, submission status dashboards, maintained code lists	Not documented on that page	Audit log of data changes, user actions and submission events; workflows not documented on that page	Informatica blog, June 2025
Syndigo	Global UDI Submission service covering GUDID and EUDAMED; GS1-certified medical device content including identifiers, attributes, images and IFU	GS1-certified GDSN data pool	Audit and status notifications on UDI submissions; approval workflows not documented on the healthcare page	Healthcare, GDSN
Stibo Systems	MDM for device-family, UDI-DI, Basic UDI-DI, packaging and market relationship data; supports GxP-controlled processes; leaves submissions to RIM	Not documented on the life sciences page	Lineage, version control, effective dating and approval workflows; audit trail management in its GxP statement	Life sciences, GxP
Sales Layer	Centralizes UDIs and maps UDI-DI to SKUs; maps fields for GUDID or EUDAMED; manages IFUs by market; pushes data to SAP Ariba or GHX	GS1 Connector by partner Qmica maps attributes to GS1 and ETIM values	Full history and version control for RA and QA; approval workflow not described on the medtech page	Medical devices, GS1 connector
Pimcore	Healthcare page: DAM for IFUs with version control and audit trails; names UDI, FDA and EUDAMED as distribution targets without describing how	Not documented (GTIN named as a classification)	Every save of a data object or asset creates a version that can be compared and restored; configurable workflows with notes and events	Healthcare, versioning, workflows
Viamedici	Healthcare page: built-in rules that check product information against regulations before publication; device traceability for recalls; SAP listed	Not documented on the healthcare page	Workflow listed; audit trail not documented on the healthcare page	Healthcare and medical technology
Akeneo	No UDI or EUDAMED features documented; names medical distributor AMG Medical as a customer for multilingual content under medical regulations	Not documented; no GDSN connector found in its App Store	Product history up to 200 versions from the last 3 years, restore on Advanced and Premium packages; Collaboration Workflows with review steps that approve or reject	Product Cloud, version restore, workflows

Two patterns stand out. The vendors that document UDI submission (Innovit, Syndigo, Informatica with BYRD Health) come from healthcare supply chain data, GDSN or enterprise MDM. The general PIMs document strong content governance but leave the regulatory step to another system. Neither is better in itself: it depends on whether you already own a RIM. To compare two enterprise options side by side, see Informatica Product 360 vs Stibo Systems.

Which one fits which starting point?

Your starting point	Look first at	Why
No RIM or UDI tool, devices sold in the EU and US, hospital buyers who want GDSN data	Innovit, Syndigo	Both document UDI submission and GDSN publication
Large manufacturer with an Informatica or enterprise MDM landscape	Informatica Product 360, Stibo Systems	Documented UDI templates and audit log (Informatica with BYRD Health), or governed UDI-DI and Basic UDI-DI relationships (Stibo Systems)
A RIM such as Rimsys or Veeva RIM already submits; you need IFUs per market, catalogs and webshop content	Sales Layer, Pimcore, Akeneo	Content governance with history and workflows; UDI data received from the RIM
SAP-centric manufacturer with many variants and print catalogs	Viamedici, Stibo Systems	SAP integration and enterprise MDM, with UDI data governed or received from regulatory systems
Distributor or wholesaler of medical products publishing manufacturer data	Syndigo, Sales Layer, Akeneo	GDSN or hospital channel output, and multilingual content
Pharma manufacturer	Your RIM first, then a PIM for commercial content	No vendor in our table documents IDMP on the pages we checked

Questions to ask every vendor

Ask for a demo on your own data, with a device that has three packaging levels and two markets. Then ask:

1. Which UDI attributes does your standard data model hold per packaging level, and is the Basic UDI-DI a separate entity?
2. Can you block a change to a UDI-DI trigger attribute (for example quantity per package or sterile status) until a new UDI-DI is issued?
3. Do you submit to EUDAMED and GUDID yourselves, through a partner, or not at all? Which method: M2M, XML upload or HL7 SPL?
4. Show the audit trail for one attribute change: who, when, old and new value, and the approval.
5. Which electronic records and signatures controls do you document, and do you provide validation documentation for GxP use?
6. How do you store IFUs and labels per market and language, and who approves a new version?
7. Which GDSN data pools do you connect to, natively or through a partner?
8. Which customers in medical devices or pharma run this setup today, and can we speak to one?

How we evaluated

We read the primary EU and US sources on MDR, IVDR, UDI, EUDAMED and GUDID on the European Commission's and the FDA's websites, the MDCG guidance on the Basic UDI-DI, and the EMA page on IDMP. For vendors, we started from the PIM and MDM vendors that buyers name for this segment, opened each vendor's own industry page, product page or help center on 3 November 2026, and filled the table only from what those pages state. Where a page does not mention a feature, the cell says not documented. We also opened the own pages of Greenlight Guru, Propel, Rimsys and Veeva to describe their role. We left out AtroPIM and inriver because their pages we found document no medtech-specific features, SAP because buyers usually meet it as the ERP that holds the material master rather than as the PIM, and Piminto because we could not find a source that identifies the product. The pattern in the ownership table is our editorial judgment from implementation practice, not a legal requirement.

PIMvendors is an independent PIM selection platform. The order of the vendor table follows how directly each vendor documents UDI submission, not a score. Regulations and EUDAMED modules change, so check the Commission's pages before you plan. For a curated medtech shortlist, see also pimselection.com's page on PIM for medical devices. To run the selection itself, follow how to select the right PIM and our guide to product data quality and governance.

Sources

• EUR-Lex, Regulation (EU) 2017/745 on medical devices, primary legal text, referenced 3 November 2026.
• EUR-Lex, Regulation (EU) 2017/746 on in vitro diagnostic medical devices, primary legal text, referenced 3 November 2026.
• European Commission, Unique Device Identifier (UDI), checked 3 November 2026.
• European Commission, EUDAMED overview, checked 3 November 2026.
• European Commission, EUDAMED UDI/device registration, checked 3 November 2026.
• European Commission, New regulations, checked 3 November 2026.
• Medical Device Coordination Group, MDCG 2018-1 Rev.4, Guidance on Basic UDI-DI and changes to UDI-DI, April 2021.
• European Commission, EUDAMED Information Centre, Guidelines on data exchange, checked 3 November 2026.
• FDA, Unique Device Identification System (UDI System), content current as of 22 July 2022, checked 3 November 2026.
• FDA, Global Unique Device Identification Database (GUDID), content current as of 17 December 2024, checked 3 November 2026.
• GS1, Unique Device Identification (UDI), referenced 3 November 2026.
• European Medicines Agency, Data on medicines (ISO IDMP standards): overview, checked 3 November 2026.
• Innovit, UDI compliance and home page, checked 3 November 2026.
• Informatica, From years to months: accelerate medical device compliance timelines, June 2025, checked 3 November 2026.
• Syndigo, Healthcare and GDSN, checked 3 November 2026.
• Stibo Systems, Life sciences and GxP compliance, checked 3 November 2026.
• Sales Layer, PIM for medical device manufacturers and GS1 Connector by Qmica, checked 3 November 2026.
• Pimcore, Healthcare and life sciences, Versioning and Workflow Management documentation, checked 3 November 2026.
• Viamedici, Healthcare and medical technology, checked 3 November 2026.
• Akeneo, Product Cloud, Restore a previous product version and What are Collaboration Workflows, checked 3 November 2026.
• Greenlight Guru, home page, checked 3 November 2026.
• Propel, Medical devices, checked 3 November 2026.
• Rimsys, home page, checked 3 November 2026.
• Veeva, MedTech, checked 3 November 2026.