EU MDR (Regulation (EU) 2017/745) adopted, replacing the Medical Devices Directive and the Active Implantable Medical Devices Directive.
MDR
EUDAMED Compliance for Medical Device Manufacturers
Register your devices in EUDAMED, structure your UDI data, and manage global registry compliance from one platform. Get EUDAMED-ready in three days with osapiens rapid onboarding.
EUDAMED is mandatory from May 28, 2026. Devices already on the EU market must be registered by November 27, 2026.
Next deadline:
28 May 2026: mandatory use of four EUDAMED modules enters force: Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, and Market Surveillance.
From this date, all new MDR and IVDR devices must be registered in EUDAMED before being placed on the EU market. Parallel national systems and alternative processes are no longer sufficient. 28 May 2026 is a hard regulatory deadline confirmed by Commission Decision (EU) 2025/2371: companies not registered risk losing access to the EU market. A second deadline follows on 27 November 2026, by which all devices already on the market before 28 May 2026 must also be registered.
Regulation timeline
What the regulation requires
EU MDR (Regulation (EU) 2017/745) entered into force on May 26, 2021, replacing the Medical Devices Directive and the Active Implantable Medical Devices Directive. It applies to any manufacturer, authorized representative, or importer that places medical devices on the EU market.
Core obligations include CE markings through conformity assessments, a quality management system that meets Article 10 requirements, Unique Device Identifier (UDI) assignment under Article 27, and registration of all devices and economic operators in EUDAMED.
From May 28, 2026, four EUDAMED modules are mandatory: Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, and Market Surveillance.
Common EUDAMED implementation challenges
Product data from ERP, PLM, and PIM systems rarely maps directly to EUDAMED
Every EUDAMED module has its own data model, attribute requirements, and validation rules. Most manufacturers hold device master data across ERP, PLM, and PIM systems in formats that do not map directly to EUDAMED's required structure. At the scale of a full device catalog, the extraction, transformation, and validation work is substantial and error-prone without automated tooling.
Global UDI registries each define their own data models, submission formats, and validation requirements
EUDAMED, FDA GUDID, SWISSDAMED, and TGA AusUDID each require separate data preparation and submission processes. SWISSDAMED mandatory device registration begins in July 2026, meaning manufacturers face two European registration deadlines within months of each other. Companies managing each registry as a separate exercise accumulate fragmented records, inconsistent product descriptions, and growing manual workloads with every new market entry.
Devices already on the EU market before May 28, 2026 must be registered in EUDAMED by November 27, 2026
For manufacturers with broad device catalogs, this creates a time-limited backlog on top of the ongoing obligation for new devices. Identifying which devices are in scope, sourcing the required UDI and product data, and completing submissions within the six-month window requires a structured program, not a manual approach.
Submission errors block market access
Each EUDAMED module applies attribute-level validation rules before a record is accepted. Errors in device classification, certificate linkage, or actor data cause submission rejections that delay market access. Identifying and correcting the source of a rejection often requires working back through multiple internal data owners and systems.
osapiens HUB for Medical Devices
Register, validate, and manage UDI data across EUDAMED and global registries.
The osapiens HUB for Medical Devices consolidates UDI and product data from ERP, PLM, PIM, and existing XLSX exports into a single validated data foundation. It structures and prepares your device catalog to meet the requirements of EUDAMED, FDA GUDID, SWISSDAMED, TGA AusUDID, and other global UDI registries.
One data foundation for EUDAMED and every global registry.
Device identity, UDI data, actor registration, and certificate records are managed on one centralized platform. The HUB structures product data to meet the specific attribute requirements of EUDAMED, FDA GUDID, SWISSDAMED, TGA AusUDID, and GDSN without re-keying between systems. Data entered once is automatically validated, transformed, and formatted for each registry.
Attribute-level validation catches errors before submission.
Before any records are submitted to EUDAMED or a global registry, the osapiens HUB runs attribute-level validation aligned to each authority's current data model and rules. Records with gaps, attributes that fail validation, and required corrections are all visible before the submission attempt. osapiens experts co-chair the EUDAMED IT Expert Group at MedTech Europe, ensuring the platform stays aligned with EUDAMED requirements as they evolve.
Full traceability from source data to EUDAMED registration.
Every device record prepared and submitted through the osapiens HUB carries a documented audit trail: data source, validation status, submission timestamp, and EUDAMED acceptance status. Access controls govern what different teams can view and edit. The platform supports both the mandatory deadline of May 28, 2026 and the legacy device registration window of November 27, 2026 .
Frequently asked questions (FAQs)
EUDAMED is the European Commission's central IT system for medical devices, established under EU MDR and EU IVDR. It provides a continuously updated record of the lifecycle of medical devices made available in the EU. EUDAMED is composed of six modules: actor registration, UDI and device registration, notified bodies and certificates, clinical investigations, vigilance and post-market surveillance, and market surveillance. From May 28, 2026, the first four modules are mandatory.
All economic operators involved in placing MDR or IVDR devices on the EU market must register: manufacturers, authorized representatives, importers, and sponsors of clinical investigations. Registration in the Actor module and obtaining a Single Registration Number (SRN) is required before any device registration can be submitted.
The four mandatory modules are: Actor Registration (all economic operators register and receive an SRN), UDI and Device Registration (every device placed on the EU market must be registered before first placement), Notified Bodies and Certificates (certificates issued under MDR and IVDR are recorded), and Market Surveillance (vigilance and post-market safety reporting). The Clinical Investigations and PMCF Studies modules are not mandatory in this first phase.
From May 28, 2026, a new MDR or IVDR device cannot legally be placed on the EU market without prior registration in EUDAMED. Parallel national systems and legacy processes are no longer accepted. Non-registered companies risk being blocked from the EU market — one of the largest medical device markets globally.
Yes. Devices placed on the EU market before May 28, 2026 must be registered in EUDAMED by November 27, 2026. Manufacturers have a six-month window to complete legacy device registrations. For companies with broad catalogs, this creates a structured backlog program that runs in parallel with the ongoing obligation for new devices.
EUDAMED, SWISSDAMED, FDA GUDID, and TGA AusUDID are separate, independently operated registries. Each authority defines its own data model, attribute requirements and submission format. Compliance with EUDAMED does not satisfy obligations in other jurisdictions. SWISSDAMED mandatory device registration begins in July 2026, meaning manufacturers face two mandatory European registration deadlines within months of each other.
Preparation time depends primarily on the completeness and structure of existing product master data. Companies with well-governed ERP and PLM data typically complete EUDAMED readiness faster than those working from fragmented spreadsheets. For manufacturers with more than a few dozen devices, the legacy device backlog deadline of November 27, 2026 means this work needs to begin immediately.
EU MDR replaced the 1993 MDD and applies identically across all EU Member States without national transposition. Key changes include stricter conformity assessment for class IIa and IIb devices, mandatory clinical evaluation against current evidence, post-market clinical follow-up requirements, the UDI system and EUDAMED registration which did not exist under the MDD, and expanded scope to Annex XVI products.
