EUDAMED and swissdamed Mandatory Registration Requirements

Mandatory registration in EUDAMED and swissdamed is finally here. By 28 May 2026, manufacturers marketing medical devices and IVDs in the EU must have completed their EUDAMED actor registration (SRN). From 28 May 2026 onward, devices first placed on the EU market must be registered in EUDAMED (UDI/Device module) before distribution. In Switzerland, the swissdamed database will also require device registration starting July 2026.

Learn more about our MDRM support, where we handle both EUDAMED and swissdamed registration support.

Questions on how MedEnvoy can support? Contact us today.

What are the EUDAMED Registration Deadlines? 

Four EUDAMED modules are already up and running for voluntary use: Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance. However, beginning 28 May 2026 these four modules will be mandatory, and manufacturers will be required to use the Actors and UDI/Devices modules. This means all devices placed on the market for the first time after that date must be registered before placement on the market takes place. 

What are the swissdamed Registration Deadlines? 

Following the breakdown of the EU–Switzerland Mutual Recognition Agreement, Swissmedic launched its own medical device database: swissdamed. The Actors module went live on 6 August 2024 and is currently mandatory for all Swiss manufacturers, Authorized Representatives, and Importers.  

The Devices module becomes mandatory on 1 July 2026, with a transition period ending 31 December 2026 (except for devices subject to vigilance action). All medical devices, IVDs, and system/procedure packs sold in Switzerland that are either new to the market or subject to vigilance reporting must be registered by that date. Until then, the Devices module is available for voluntary registration, which manufacturers are encouraged to do via their Swiss Authorized Representative (CH-REP). 

• 6 August 2024: Actor registration mandatory for all Switzerland-based Economic Operators. 
• 1 July 2026: Device registration becomes mandatory; beginning of transition period. 
• By 31 December 2026: All devices must be registered in swissdamed. 

Device registration fees start July 2026. The exact fees for registration are pending.

EUDAMED Registration Requirements 

As discussed, EUDAMED’s Actors, Devices, Certificates, and Market Surveillance modules will be mandatory as of 28 May 2026, but manufacturers will primarily use the Actors and Devices modules. The main obligations for manufacturers for these modules are outlined below:

Actor Module (Economic Operator Registration): Currently voluntary, but mandatory from 28 May 2026, the Actor module covers manufacturers, authorized representatives (EU-based), system/procedure pack producers, and importers. 

• All Economic Operators must register to obtain a Single Registration Number (SRN). 
• For manufacturers and SPP producers, Actor registration must be complete before any device can be registered in the Devices module. 

Devices Module (UDI Registration): Currently voluntary, but mandatory from 28 May 2026, this module requires manufacturers of devices and IVDs under MDR/IVDR to upload structured device data. Key data elements include: 

• Basic UDI-DI 
• Risk class 
• Storage and handling conditions 
• Critical warnings 
• Catalogue number, etc. 

Notified Bodies upload certificate data via the Certificates module, but manufacturers must ensure their Basic UDI-DI is registered and correctly linked to relevant certificates to complete device registration. 

Swissdamed Registration Requirements 

At this time, swissdamed only has two modules, which are outlined below:

Actor Module (Economic Operator Registration): Mandatory since 6 August 2024, the Actor module covers Swiss-based manufacturers, authorized representatives (CH-REPs), importers, and Swiss-based procedure pack producers. 

• Swiss manufacturers must register directly. 
• Non-Swiss manufacturers cannot access swissdamed. Instead, their CH-REP must register and link the foreign manufacturer in swissdamed. 
• Registration in this module is required before any device can be registered in the UDI module. 

Devices Module (UDI Registration): As of 18 August 2025, medical devices (including IVDs, systems, and procedure packs) can be registered on a voluntary basis. swissdamed’s design is based on EUDAMED and the data elements are largely the same, specifically Basic UDI and UDI-DI data. Some EU-specific data elements do not appear in swissdamed (e.g., market status in EU member states). swissdamed-specific data elements include: 

• Swiss market status 
• Swiss single registration number (CHRN), if applicable 
• Swiss authorized representative, if applicable 
• Versioning of records 

How to Submit Data to EUDAMED and swissdamed 

EUDAMED offers three methods for submitting registration data, each with distinct technical requirements and use cases. swissdamed’s data model is largely aligned with EUDAMED, but there are structural differences and no link between the two systems. Data must be uploaded to each system separately.

Here are EUDAMED’s three upload options along with their swissdamed implications: 

Submission Method	How It Works	Pros	Cons	swissdamed Compatibility
User Interface (UI) (Manual Entry)	Users log into the EUDAMED portal and manually enter device and actor data using a web browser. No technical setup is required.	No IT development required. Suitable for low-volume or one-off submissions.	Time-consuming and error-prone at scale. Not practical for large portfolios or frequent updates.	Not currently supported. Device data must be submitted via XML.
XML Upload via UI (Semi-automated)	Structured XML files are uploaded and downloaded through the EUDAMED portal. Files must conform to EUDAMED’s XSD schemas and validation rules.	Enables bulk uploads and reduces repetitive manual entry.	Requires some IT support to generate compliant XML. Validation errors can cause delays.	Supported. swissdamed accepts XML uploads aligned with EUDAMED’s current XSD schema.
Machine-to-Machine (M2M) (Fully automated)	A direct system-to-system connection submits structured XML data to EUDAMED in real time without manual intervention.	Scalable and efficient for large portfolios. Minimizes long-term manual effort and errors.	Complex and costly to implement. Best suited for high-volume manufacturers.	Not supported at this stage. Only XML uploads are currently accepted.

How to Choose your EUDAMED Data Transfer Method 

Select the appropriate data transfer method based on your data volume, internal IT capabilities, and the frequency of updates required. While manual entry may be suitable for limited and infrequent submissions, automation becomes increasingly important as complexity grows. For organizations managing dual registrations in EUDAMED and swissdamed, XML-based automation is typically the most efficient and sustainable approach, enabling consistent data reuse, reduced manual effort, and improved compliance control across both systems. 

Key EUDAMED and swissdamed Registration Challenges 

EUDAMED and swissdamed registrations typically present two core hurdles: ensuring robust data quality and achieving technical compatibility across systems and formats. As the registration deadlines approach, many manufacturers are also consolidating portfolios, aligning internal master data, and coordinating submissions under significant time pressure—often with constrained regulatory and IT resources.

Here are key challenges manufacturers need to be aware of: 

Bottlenecks with Notified Bodies, Competent Authorities, and ARs 

Actor registration is not complicated, but it depends on multiple parties to complete, especially for non-EU or non-Swiss manufacturers. Your authorized representative (AR) must verify the submission, and the EU national competent authority must approve it. Minor mistakes, such as missing attachments or inconsistency in the data provided, can result in rejections. While approvals can be obtained on the same working day, the actual timeframe depends on the AR’s responsiveness and the competent authority’s workload. As the registration deadline nears, review request volume will rise, which could stretch review times.  

Given the different deadlines for devices registrations by manufacturers and certificates registrations by Notified Bodies, coordinating with the Notified Body involved is advisable for manufacturers with high-risk devices (i.e. Class IIb, Class III medical devices and high risk IVDs) to avoid any last-minute delays and ensure links are established ahead of the deadline. 

Data Quality and Technical Validation Failures 

Data quality and technical validation remain among the most common causes of delay in EUDAMED and swissdamed registrations. Both databases rely on highly structured data models with extensive field-level validations, cross-field dependencies, and strict grouping logic. Inconsistent master data such as variations in risk class, essential characteristics, UDI-related attributes, or other device-defining parameters across devices intended to be registered together can trigger validation errors that are difficult to diagnose and time-consuming to resolve. 

Technical validation failures frequently stem from incomplete or misaligned data mappings, particularly when information is sourced from multiple internal systems or legacy documentation. Even minor discrepancies in controlled vocabularies, reference codes, or formatting (for example, EMDN selection, units of measure, or code lists) can prevent a successful submission. EMDN coding is a common blocker: EUDAMED expects the most granular applicable code, and if the supporting technical documentation only substantiates a higher-level category, registration may be halted until the documentation and data can be reconciled. These issues are often detected late in the process (i.e. during upload checks or final validation) driving rework, consuming scarce regulatory and IT capacity, and increasing the risk of missed timelines. 

Internal Readiness and Infrastructure Gaps 

Many manufacturers still depend on spreadsheets to manage device master data—an approach that is inherently vulnerable to inconsistent entries, weak version control, and manual transcription errors. At the same time, internal infrastructure is often not designed for structured regulatory data exchange. Organizations operating legacy systems or heavily customized ERPs may find they cannot reliably produce XML outputs aligned to EUDAMED schemas, nor support scalable machine-to-machine (M2M) data transfers. When this capability is missing, teams are pushed back to manual entry, repeated file rework, or other labor-intensive workarounds driving higher administrative burden and increasing the risk of submission delays. 

Compounding this challenge, most regulatory teams were not resourced to take on what is effectively a data engineering and validation effort. As deadlines approach, capacity is stretched between ongoing compliance activities and the additional workload of preparing EUDAMED and swissdamed submissions. Without dedicated ownership, technical support, and clear alignment between Regulatory, IT, and QA, even well-structured registration initiatives can slow significantly or stall at the point of data preparation and validation.   

How to Prepare Now for EUDAMED and swissdamed Registration

Organizations with nimble teams, with well-governed device data and modern regulatory-ready systems will be in a position to start their EUDAMED and swissdamed registrations now, but many manufacturers still need to make fundamental changes to how device data is organized, submitted, and maintained before they can proceed with UDI registration. Here is what manufacturers should focus on right now: 

Here is what manufacturers should focus on right now: 

Centralize and Standardize Data Across Systems 

Establish a single “source of truth” for device master data and align it to both EUDAMED and swissdamed data models. Early schema alignment reduces downstream rework, minimizes duplicate data handling, and improves consistency across submissions.

Clean and Validate Your Device Master Data 

UDI registration depends on complete, consistent, and traceable data. Ensure all records linked to a single Basic UDI are coherent and that each Basic UDI and UDI-DI is mapped correctly to the relevant product family and packaging configuration. This is particularly critical for large or complex portfolios were small inconsistencies scale into significant operational efforts.

Review and Update Your QMS

Your Quality Management System (QMS) should clearly describe how regulatory data is generated, controlled, and updated including UDI assignment rules, database access controls, change management, and ownership for updates across multiple jurisdictions and databases. Auditable governance is essential once registrations move from “project mode” into business-as-usual maintenance.

Map Out Legacy Device Coverage 

Device registration is not limited to MDR/IVDR-certified products. It also includes legacy devices that remain CE marked under MDD, AIMDD, or IVDD and are still placed on the market. Manufacturers should proactively map the full scope of legacy device coverage, continuously monitor market status, and ensure records are promptly updated when products are discontinued, modified, or transitioned to MDR/IVDR. This lifecycle tracking must be embedded in the internal product database and consistently reflected in supporting regulatory documentation to avoid gaps, inconsistencies, and late-stage remediation.

Test Your Submission Method 

Confirm early how your organization will submit and maintain device data whether through manual entry, file-based (bulk) uploads by XML or M2M exchange and ensure the chosen approach is fit not only for initial registration but also for ongoing updates and corrections. Begin testing as soon as possible in available sandbox or test environments to validate technical compatibility, data structure, and internal workflows. Early testing is critical to identify schema misalignments, coding issues such as EMDN granularity, validation errors, and internal data mapping gaps well before submission deadlines. Addressing these issues in advance reduces rework, prevents last-minute bottlenecks, and provides a more predictable path to timely registration and sustainable data maintenance.

Get Ahead of EUDAMED and swissdamed Deadlines

EUDAMED and swissdamed registration have a lot of moving parts and failure to register in time could jeopardize market access if manufacturers are not prepared. MedEnvoy’s Medical Device Registration Management (MDRM) service offers an integrated, end-to-end solution. With expert guidance, structured onboarding, and a scalable platform that supports both EUDAMED and swissdamed workflows, MDRM removes friction from registration and ongoing compliance. When you appoint MedEnvoy as both your EAR and CH-REP, swissdamed registration is included at no additional cost. 

If you are looking to streamline the process and stay ahead of EUDAMED and swissdamed deadlines, talk to our team.