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How to generate EUDAMED ID DI for MDD devices and what manufacturer device code is needed?

Anonymous · Published February 12, 2026 · 1 comment
When registering MDD devices in EUDAMED using the EUDAMED ID DI, is a manufacturer device code required, and where can it be obtained? Does EUDAMED generate the EUDAMED ID and DI automatically, or does the manufacturer need to provide specific codes?

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Anonymous 4 months ago
Are you asking about registration for legacy MDD devices or MDR devices?
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7 Answers

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
For software medical devices, the MDR requires the UDI carrier to be present on the label. However, for software, the barcode or datamatrix (AIDC) is not mandatory—only the human-readable interpretation (HRI) is required. If your notified body asks you to include the barcode or QR code, you can refer to MDR Annex VI, Part C, 6.5.4(d) as justification for including only the HRI. There are also transition periods for some classes of devices, so make sure you're following the correct timeline for your device class.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
In the About dialog of your medical software, you only need to show the CE mark with the 4-digit Notified Body number. You don’t have to mention the Notified Body’s name or logo unless they specifically provide a logo and instructions for use. If they do, follow their guidelines for color, size, etc. But generally, the CE mark plus number is sufficient for compliance.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
After ISO 13485 certification, you should close out any audit findings and address them in your Corrective and Preventive Actions (CAPA) process. Expect annual surveillance audits from your certification body to check your QMS is functioning. Plan your yearly quality and regulatory activities, such as internal and supplier audits, management reviews, and projects like MDR transitions. Set up processes for change management and risk management, and track QMS and device changes. Keeping a good plan and evaluation process helps make sure you stay compliant and ready for audits.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
When registering MDD devices in EUDAMED, you need an SRN (Single Registration Number), which you get after company registration. The manufacturer device code isn’t always a specific code you already have—in some cases, you can use a major version number or a similar identifier. EUDAMED can generate the EUDAMED ID and DI based on the information you provide. If you’re unsure, check the company registration module and consult your local Competent Authority for guidance.

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Anonymous ·
In theory, you can have ISO 13485 certification and MDR conformity assessment done by different bodies. However, splitting them can lead to complexities, as you might face differing interpretations of requirements from each body. For example, your ISO 13485 certifying body might assess your QMS differently than your MDR notified body. This could make things more complicated, especially if you get conflicting feedback.

In practice, many notified bodies offer both services, and it's usually more efficient to combine them. Still, some organizations choose to get ISO 13485 certification first, either for strategic reasons (e.g., to enter other markets or to get the QMS in place before products are ready) or to make the MDR assessment smoother later on. Just be prepared for extra effort in aligning both bodies' requirements.

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Anonymous ·
The liability of the Person Responsible for Regulatory Compliance (PRRC) under the MDR mostly falls on the manufacturer, not the individual. The PRRC's role is to ensure regulatory compliance, but if the company fails to comply with the MDR, the legal responsibility is generally with the manufacturer. Some countries may have specific laws, but in the EU, the PRRC is not personally liable for the company’s regulatory breaches, as long as they fulfill their duties in good faith. It's a good idea to have a formal designation letter and possibly include the PRRC role in the company's liability insurance.

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Anonymous ·
For biocompatibility testing, NAMSA is a widely recognized lab that covers a broad spectrum of tests. Some smaller labs can handle simpler tests like cytotoxicity. For electromagnetic compatibility (EMC) testing, organizations like DEKRA, KIWA, and TÜV are commonly used in Western Europe. Eurofins is another option for biocompatibility. Ultimately, the choice depends on your location and the specific tests you require.

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All questions
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Is a new QMS audit required for MDR certification if we already have MDD and ISO 13485 certification?

Anonymous · 1 comment
4 months ago
Our company has a device certified under the MDD with a certified QMS (quality management system). We are planning to transition to MDR certification. Do we need to undergo a new QMS audit according t
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Is ISO 13485 certification required before CE marking for software medical devices in the EU and Switzerland?

Anonymous · 1 comment
4 months ago
We want to certify our software as a medical device in the EU and Switzerland. I have two questions: • Is it necessary to first obtain ISO 13485 certification before applying for CE marking? What are
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For your first question: MDR requires manufacturers to establish a QMS (Quality Management System), as stated in Article 10 MDR. For class IIa devices

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Is ISO 13485 certification required before CE marking for medical device software in the EU and Switzerland?

Anonymous · 1 comment
about 1 year ago
Our company is planning to certify our software as a medical device in the EU and Switzerland. We have two questions: • Is it necessary to obtain ISO 13485 certification before pursuing CE marking? Wh
Accepted 1 answer

One of the requirements for CE marking, depending on the classification of your device, is that you have a certified QMS in place. The MDR requires ma

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