EUDAMED becomes mandatory from 28 May 2026
A practical EUDAMED data readiness playbook for manufacturers
For many medical device and in vitro diagnostic (IVD) manufacturers, European Database on Medical Devices (EUDAMED) has sat in the background for years, technically available, often partially used, and sometimes deferred in favour of national systems. That period is coming to an end. From 28 May 2026, the European Commission has confirmed that the first four EUDAMED modules move from voluntary to mandatory use under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
This change is not a soft “encouragement” or a policy preference. It is a legally triggered obligation following publication of Commission Decision (EU) 2025/2371 in the Official Journal of the European Union (OJEU) on 27 November 2025, which confirmed that these modules are fully functional. The six‑month transition period is already running.
The practical challenge is not access to EUDAMED itself, but data readiness. Organisations that treat this as a simple system switch often underestimate the effort needed to align actor records, UDI hierarchies, device master data and certificate linkages. This article sets out a practical, regulator‑aligned playbook to help manufacturers move from awareness to execution.
What changed: from functionality notice to mandatory use
The regulatory trigger for mandatory EUDAMED use is not an arbitrary date. Under Regulation (EU) 2024/1860, EUDAMED modules become mandatory only once the European Commission formally declares them functional via a notice in the OJEU.
On 27 November 2025, the Commission published such a notice confirming that the following four modules meet their functional specifications:
- Actor registration
- UDI/Device registration
- Notified Bodies & Certificates
- Market Surveillance
This publication automatically triggered a six‑month transition period, ending on 28 May 2026. From that date, obligations linked to these modules must be fulfilled exclusively through EUDAMED. Parallel national databases or alternative processes are no longer sufficient for these areas.
Importantly, not all EUDAMED modules are affected yet. The Vigilance and Clinical Investigations / Performance Studies modules remain outside mandatory scope until they are separately declared functional. This distinction matters when prioritising internal resources and programme scope.
One manufacturer assumed all six modules would become mandatory together and diverted resources into vigilance workflows that remain non‑mandatory. Meanwhile, core actor and device data were left incomplete, creating a potential compliance risk.
Which EUDAMED modules are mandatory and who must act
From 28 May 2026, mandatory use applies to all economic operators whose regulatory obligations map to the four declared modules. This includes manufacturers, authorised representatives (ARs), importers and notified bodies.
Actor registration
All relevant economic operators must be registered in EUDAMED and hold a valid Single Registration Number (SRN) before placing devices on the EU market. The Actor Registration module, previously voluntary, becomes mandatory from 28 May 2026.
UDI/Device registration
- Devices placed on the market on or after 28 May 2026 must be registered in EUDAMED before market placement.
- Devices already on the market before that date benefit from a 12‑month transition, with registration required by 28 November 2026.
Notified bodies & certificates
Notified bodies must upload certificate information into EUDAMED. For MDR and IVDR certificates issued before mandatory use, an 18‑month transition period applies, ending on 28 May 2027.
Market surveillance
Competent authority market surveillance activities linked to EUDAMED become mandatory from 28 May 2026, with no transition period.
Key deadlines and ownership: who does what
Clear ownership is critical. While manufacturers often lead EUDAMED programmes, many obligations sit across multiple parties.
Manufacturers:
- Ensure actor registration is complete and accurate (including correct roles and mandates).
- Register new devices before placement on the market.
- Complete legacy device registration by 28 November 2026.
Authorised Representatives:
- Verify non‑EU manufacturer actor registrations.
- Maintain accurate mandate linkages in EUDAMED.
Importers:
- Register as actors and ensure correct linkages to manufacturers.
Notified Bodies:
- Upload certificate data and maintain certificate lifecycle information within the specified transition period.
From a governance perspective, this means manufacturers must coordinate actively with ARs and notified bodies rather than treating EUDAMED as a purely internal IT activity.
Practical guidance: data readiness EUDAMED checklist
A successful EUDAMED implementation starts with data discipline, not system training. The following checklist reflects what “good” typically looks like in practice (advisory guidance).
Core data foundations
UDI and device master data
Certificates and notified body data
Access and governance
Potential failure modes
Manufacturers preparing for EUDAMED mandatory use should be alert to recurring risk areas such as:
- Duplicate actor registrations created during voluntary use phases.
- Incorrect actor role selection leading to invalid SRNs.
- Inconsistent Basic UDI‑DI groupings across product families.
- Device data that conflicts with technical documentation.
- Legacy devices overlooked during portfolio mapping.
- Certificate records missing clear linkage to registered devices.
- Over‑reliance on notified bodies to “fix” data issues.
- Insufficient internal access controls and administrator coverage.
- Poor reconciliation between internal ERP systems and EUDAMED data.
- Treating EUDAMED readiness as a one‑off project rather than an ongoing compliance activity.
A practical 30‑60‑90 day EUDAMED implementation plan
PharmOut Services & Training
PharmOut supports medical device and IVD manufacturers with practical MDR and IVDR implementation, including EUDAMED readiness, data governance design and internal audits. Our consultants combine regulatory expertise with hands‑on delivery experience to help organisations move from compliance theory to operational reality. Targeted training and advisory support can be tailored to manufacturer size, device complexity and market footprint, aligning with existing quality management systems and regulatory strategies.
Explore elearning and public courses via onlinegmptraining.com, or contact us via the website or via email to tailor workshops to your needs.
Frequently Asked Questions (FAQ)
Mandatory use of the first four EUDAMED modules applies from 28 May 2026, following publication of the European Commission functionality notice in the Official Journal of the European Union.
Mandatory use applies to the Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance modules; Vigilance and Clinical Investigations modules remain non‑mandatory at this stage.
Yes – devices placed on the market before 28 May 2026 benefit from a 12‑month transition period and must be registered in EUDAMED by 28 November 2026.
No – regulators are primarily concerned with data accuracy, consistency, and governance, not system access or user training alone.
Many organisations underestimate the effort required to reconcile actor data, UDI structures, and certificate linkages across internal systems, authorised representatives, and notified bodies.
