The EUDAMED eIFU URL Deadline Is Not a Soft Target

28 May 2026. After that date, EUDAMED will reject any new device registration that lacks a valid, publicly accessible eIFU URL — no grace period, no override, no exceptions. The EUDAMED eIFU URL registration May 2026 deadline was formalised by Commission Decision 2025/2371, which declared the UDI/Devices module fully functional on 27 November 2025 and triggered the six-month countdown.

The requirement itself is not new. Commission Implementing Regulation (EU) 2021/2226 established the eIFU URL obligation years ago. What changed in late 2025 is that EUDAMED now has the infrastructure to enforce it at registration. If you have not yet assigned a persistent URL to your devices, the window closes on 28 May 2026.

Regulatory Timeline: From Published to Mandatory

The six-month window exists to give manufacturers time to assign and test URLs, not as a buffer for late starters.

Scope: Who Registers, What Is Exempt, and the Legacy Device Question

Who Must Register

• All medical device manufacturers placing Class I, II, or III devices on the EU market (1)

• All IVD manufacturers placing Class A or B devices on the EU market (2)

• Distributors, importers, and resellers acting as responsible manufacturers in the supply chain

• Any entity providing eIFU as a primary or supplementary instruction format

The distributor question catches people out. If you repackage, relabel, or modify a device, you become the manufacturer of record and carry the registration obligation. (3)

Grace Periods and Existing Registrations

Devices already registered in EUDAMED before the mandatory date do not face immediate de-registration. The rule triggers at the next registration event — renewal, revalidation, extension, or any modification. At that point, an incomplete URL field blocks the update.

There is no post-deadline grace period for new registrations. The regulation is explicit on this point.

Legacy Devices

Devices placed on the market under the old Medical Device Directive before MDR/IVDR transition must also comply with eIFU URL requirements if they remain available for purchase and carry electronic instructions. (4)

What EUDAMED Is and How the UDI/Devices Module Works

EUDAMED — the European Database on Medical Devices — is the single regulatory repository for all device registrations in the EU. Built under MDR 2017/745, it replaced fragmented national databases and created a single access point for manufacturers, notified bodies, regulators, and the public.

The UDI/Devices module, mandatory from 28 May 2026, captures the unique device identifier, all associated metadata, and the persistent URL to the device's eIFU. That URL is public — anyone accessing EUDAMED can view and use it. EUDAMED validates the URL at submission with an accessibility check, so a URL that is registered but unreachable will fail. (5)

Step-by-Step: How to Register Your eIFU URL in EUDAMED (Part B, Point 22)

Step 1: Choose Your eIFU URL

The URL you register in EUDAMED should point to your eIFU website or portal — the publicly accessible location where users can find the device's instructions for use. The regulation requires the URL to give access to the eIFU; it does not mandate a direct link to a specific document file.

The best practice is to register a generic portal URL that remains stable across your entire catalogue — for example, https://eifu.yourcompany.com. From there, users navigate to the specific device. This approach keeps the registered EUDAMED address unchanged even as products are added, updated, or discontinued. Avoid registering a product-specific document URL, as it creates fragility: if the document path changes, the EUDAMED registration becomes invalid.

The URL must be:

• Persistent — accessible for the entire device lifecycle

• Publicly accessible — no login, authentication, payment, or geographic restriction

• Stable — company-controlled, not dependent on third-party shorteners

• HTTPS-compliant — expected by regulators; HTTP is flagged during audits

Your IT team will ask whether a subdomain is acceptable. It is, provided you control it and can guarantee continuity through infrastructure changes, maintenance and company transitions.

Step 2: Access the UDI/Devices Module

Log in with your EUDAMED manufacturer credentials. Navigate to the UDI/Devices module. For a new device, begin a new registration. For an existing device being updated, select "Edit Registration." EUDAMED's test environment is called the Playground — use it to confirm field locations before your first live submission.

Step 3: Locate Part B, Point 22

In the device data entry form, scroll to Part B, Point 22 of Annex VI (MDR 2017/745) — the field labelled "Electronic Instructions for Use URL." (6) Some manufacturers spend time searching for a general "eIFU section" — go directly to Part B, Point 22.

Step 4: Enter and Validate the URL

Enter the full URL including the https:// protocol. EUDAMED performs an accessibility check. Do not use shortened URLs (bit.ly, tinyurl) — third-party shorteners can be deactivated, breaking persistence. After submission, test the URL from outside your corporate network to confirm it loads without authentication.

Step 5: Handle Multi-Language Variants

If your eIFU exists in multiple languages, confirm all variants are accessible from the registered URL. A portal with language selection satisfies this requirement. You do not need separate EUDAMED registrations per language.

Step 6: Submit and Verify in the Public Registry

Verify in EUDAMED's public search that your URL appears correctly in your device record. This is the link a notified body or competent authority will use during an audit. Test it from an external browser.

What Makes a URL "Persistent": Operational Requirements

Persistent means stable for the entire commercial lifecycle of the device — and for the post-market surveillance period after discontinuation (typically three years after withdrawal from market).

Permanence: If your company undergoes a website redesign, domain migration, or rebranding, the registered URL must continue to resolve. Update EUDAMED immediately if the URL changes. 2025/1234 (7)

Public Access: No login walls, paywalls, or geographic restrictions. Any user anywhere must be able to reach the eIFU without a barrier.

Stability: Use a company-controlled, branded URL. Do not rely on third-party URL shorteners. Document backup infrastructure and continuity plans in your device master file. Registering a generic portal URL rather than a per-product document URL is the most resilient long-term approach — the registered address stays the same regardless of how your catalogue evolves.

Navigability: The URL should land on a page where the correct eIFU is clearly accessible. A portal with a device search or a product listing based on unique identifiers is appropriate. What is not appropriate is a generic marketing homepage where finding the eIFU requires multi-step navigation with no clear path.

Protocol: HTTPS is best practice. HTTP is not explicitly forbidden by the regulation, but inspectors flag it, and your IT team will ask. The answer is yes — use HTTPS.

Common Misconceptions

Misconception 1: "We Only Need to Register if Selling Into the EU After May 2026"

Any manufacturer already in the EU supply chain must register. If your product is available for purchase in the EU — through any channel — and it carries an eIFU, the URL requirement applies.

Misconception 2: "We Need a Separate URL for Every Device"

You do not. A single portal URL registered in EUDAMED can serve your entire catalogue, provided users can navigate to the correct device eIFU from the portal. A generic eifu.yourcompany.com registered once is far easier to maintain than hundreds of product-specific URLs that each require individual management. Matrix eIFU uses this architecture by design — one persistent portal URL per manufacturer account, so the EUDAMED-registered address does not need updating as products are added or retired.

Misconception 3: "The Deadline Only Applies to Class III Devices"

The obligation applies to all device classes — Class I, II, and III under MDR; Class A and B under IVDR — where eIFU is provided. Risk classification does not change the requirement.

Misconception 4: "There Is a Grace Period After 28 May 2026"

There is not. EUDAMED blocks new registrations lacking a valid URL from the mandatory date. This is technical enforcement at the point of submission, not a finding to be remediated after the fact.

Misconception 5: "Paper Instructions Exempt Us from the URL Requirement"

If a manufacturer provides eIFU in any form and the device is registered in EUDAMED, the URL must be supplied. Providing both paper and electronic formats creates no exemption.

Misconception 6: "Distributors Are Exempt"

Distributors, importers, and resellers acting in the manufacturer role must also register and supply the URL. The obligation follows regulatory responsibility, not commercial title.

Switzerland's Separate Deadline: swissdamed (1 July 2026)

Switzerland operates swissdamed, its own device registration database, with a mandatory deadline of 1 July 2026 — a bit more than one month after the EU deadline. EU and Swiss registrations are independent: EUDAMED registration does not carry over to swissdamed. The same persistent URL may be registered in both.

What Happens After 28 May 2026: Enforcement Reality

From the mandatory date, EUDAMED validates the eIFU URL field at submission. A missing or inaccessible URL is a hard block — the registration does not complete.

Registration is not a one-time event. Manufacturers must monitor URL accessibility regularly, update EUDAMED immediately when the URL changes for any reason, and maintain access for the post-market surveillance period after discontinuation. Published enforcement guidance from EU competent authorities has not yet been issued as of May 2026. What regulatory practice indicates is that inspectors will verify the URL works, the eIFU content matches approved labelling, and a URL continuity plan exists in the device master file.

Frequently Asked Questions

What is a persistent URL in EUDAMED, and why does it need to be persistent?

A persistent URL is one that remains continuously accessible for the entire device lifecycle without authentication, payment, or geographic restriction. EUDAMED requires persistence because regulators and notified bodies must be able to reach your eIFU at any time — during an audit, a surveillance review, or a complaint investigation. An inaccessible URL means the device's eIFU cannot be verified.

Where exactly do I submit the eIFU URL in EUDAMED?

The eIFU URL goes into Part B, Point 22 of Annex VI, in the UDI/Devices module, under the field labelled "Electronic Instructions for Use URL." This is the only field EUDAMED checks for eIFU URL compliance at registration. If you cannot locate it, use the EUDAMED Playground test environment.

Can I use a generic portal URL or does each device need a unique URL in EUDAMED?

A generic portal URL is not only acceptable — it is the recommended approach. Registering your eIFU portal URL (e.g., https://eifu.yourcompany.com) means the registered address stays the same as your catalogue grows. The portal then handles navigation to the specific device. Registering per-product document URLs creates maintenance overhead and fragility every time a document path changes.

What happens if I don't register my eIFU URL by 28 May 2026?

From the mandatory date, EUDAMED blocks any new device registration or update that does not include a valid, accessible eIFU URL. There is no grace period. A device that cannot complete its EUDAMED registration cannot legally be placed on the EU market. 2024/1860)

Do I need to register in both EUDAMED and swissdamed if I sell in EU and Switzerland?

Yes. The two databases are independent. EUDAMED registration does not create a Swiss record. Complete registrations in both systems. The same persistent URL may be used in both. Switzerland's deadline is 1 July 2026.

What if our company is acquired or rebrands — does the URL obligation transfer?

Yes. The acquiring or rebranded entity is responsible for URL continuity. If the URL changes, EUDAMED must be updated immediately. Document URL continuity plans in your Technical File before any anticipated corporate event.

Compliance Checklist Before 28 May 2026

• Audit your device portfolio. Identify all devices registered or to be registered in EUDAMED with eIFU provided.

• Choose your portal URL strategy. A single generic portal URL per company is more resilient than per-product document URLs.

• Verify accessibility. Confirm the URL is HTTPS, publicly accessible, and tested from outside your corporate network.

• Confirm hosting continuity. Document who controls the domain.

• Handle multi-language variants. Verify the portal handles language navigation clearly.

• Plan for Switzerland separately. Prepare for swissdamed registration within the 1 July 2026 deadline.

• Update your device master file. Include URL continuity controls as a documented element of your eIFU management process.

• Register before 28 May 2026. Enter the URL in Part B, Point 22, Annex VI. Verify it appears correctly in EUDAMED's public registry.

• Set up ongoing monitoring. A broken URL post-registration is a non-conformity. Confirm accessibility regularly.

Sources

• Regulation (EU) 2017/745 (Medical Device Regulation)

• Commission Implementing Regulation (EU) 2021/2226

• Regulation (EU) 2025/1234

• Commission Decision (EU) 2025/2371

• Regulation (EU) 2024/1860

• Deadline for Device Registration in swissdamed

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(1) MDR 2017/745
(2) IVDR 2017/746
(3) Regulation (EU) 2017/745, Article 16
(4) Commission Decision 2025/2371
(5) Regulation (EU) 2024/1860
(6) Article 29, Regulation (EU) 2017/745
(7) Regulation (EU) 2021/2226, amended by Regulation (EU 2025712349)