WHY THE INDIA-EU FTA IS A GAME-CHANGER FOR MEDICAL DEVICE MANUFACTURERS
Europe, 30 Jan 2026 — In a significant step towards improving medical device traceability across the European Union (EU), the European Commission has officially rolled out the EUDAMED user guide for Unique Device Identification v 2.22.0 (UDI) Devices. This new regulation requires manufacturers to ensure all medical devices are properly registered in EUDAMED before entering the EU market.
For medical device manufacturers, this means aligning their internal processes with the new EU Regulations for device identification, registration, and monitoring. As part of the update, EUDAMED registration is now mandatory for all medical devices sold in the EU, ensuring a higher level of accountability and safety. Here’s a breakdown of the key aspects of this update and what you need to know to stay compliant.
WHAT’S NEW?
The implementation of the UDI system introduces a centralized and structured way for manufacturers to track and register their devices. Under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), a Unique Device Identifier (UDI) is now required for all medical devices. This UDI will be linked to EUDAMED, the EU’s central database, which aims to streamline the process of device registration and improve post-market surveillance.
This new rule is not just about compliance; it’s about improving transparency and safety. For manufacturers, the task now is ensuring they fully register all their devices under the UDI system.
WHY SHOULD MANUFACTURERS CARE?
- Mandatory Device Registration – No device can be placed on the EU market without first being registered in EUDAMED. This includes not only the device itself but also all associated system and procedure packs (SPPs). To get started, manufacturers need to create an EU Login account, ensuring they are registered as an actor in the EUDAMED database, which is a crucial step in the EUDAMED registration process.
- Unique Identifiers for Each Device – Every device will need to be assigned a Basic UDI-DI (the device family identifier) and a Unique Device Identification-DI (the specific device identifier). This provides manufacturers with a clear traceability path from production to end use, making it easier to track devices in case of recalls or regulatory inquiries, in line with the EU Regulations.
- Detailed Information Requirements – Manufacturers must provide a broad array of information about their devices, such as risk class, intended use, and packaging details. For systems or procedure packs, additional details will be required to reflect the multiple components that make up these packs, all of which must be documented under EUDAMED registration.
- Managing “Legacy” Devices – It is a common misconception that legacy devices are simply “phased out.” In reality, devices placed on the market under old directives (MDD, AIMDD, IVDD) have a distinct registration path. While they may not use a standard Unique Device Identification-DI (instead using a EUDAMED DI/ID), they must still be registered for traceability. EUDAMED even allows you to link a Regulation Device to its Legacy equivalent to maintain a clear historical record, ensuring full compliance with the updated EU Regulations.
- Packaging and Multi-Level Requirements – Devices often come in different packaging levels. For compliance, each level will need its unique UDI code, ensuring clear visibility through all stages of distribution. This requirement is part of the broader scope of EUDAMED registration and is vital for maintaining compliance with EU Regulations.
THE STEPS TO COMPLIANCE
- Accessing EUDAMED – Before diving into the device registration process, manufacturers must create and link their EU Login account. With this, they can gain access to the platform and begin registering devices under their business. This step is essential for completing the EUDAMED registration and ensures manufacturers are correctly registered as an actor in the system, in accordance with EU Regulations.
- Selecting the Correct Device Type – Depending on the regulation (MDR or IVDR), manufacturers will need to categorize their devices correctly. Whether it’s a system or procedure pack, or a standard medical device, ensuring the correct classification will help avoid complications down the line and ensure proper EUDAMED registration.
- Enter Device Details – The registration process involves entering all required details, including device classification, risk class, and whether the device contains any hazardous substances. Manufacturers must also specify if the device is single-use, the clinical sizes, or if it contains any substances of concern. Accurate EUDAMED actor registration is critical here to ensure each device is linked to its respective manufacturer for full regulatory compliance.
- Maintaining Data Accuracy – One of the key challenges is ensuring that once a device is registered, any changes to the device’s status, characteristics, or packaging must be promptly updated in the database. Manufacturers must commit to keeping their device data accurate and up-to-date to avoid delays or issues when placing their products on the market, adhering to the ongoing requirements of EUDAMED registration and EU Regulations.
- Submitting for Review and Approval – After completing the registration process, manufacturers can submit their entries. For some devices, the data might need validation from a Notified Body. The registration status will be either “Registered” or “Submitted” based on whether the data requires external validation. This step finalizes the EUDAMED registration and ensures that all information meets the necessary EU Regulations for market entry.
WHAT HAPPENS IF YOU DON’T COMPLY?
Under the MDR and IVDR, registration in EUDAMED is a legal prerequisite for market access. If a manufacturer fails to properly register their devices and associated System or Procedure Packs (SPPs), they are legally prohibited from placing those products on the Union market. Beyond the immediate halt in sales and revenue, the high level of public transparency in EUDAMED means that any compliance gaps are visible to the entire healthcare chain, posing a significant risk to professional reputation. Failure to complete proper EUDAMED registration and EUDAMED actor registration can lead to scrutiny and loss of trust in the market, as the public and healthcare professionals rely on the database for accurate and transparent product information.
CONCLUSION
The implementation of the EUDAMED UDI/Devices module marks a fundamental shift in the European medical device landscape. For manufacturers and System/Procedure Pack producers, this transition demands high levels of data integrity and a proactive approach to digital documentation. While the registration process requires navigating complex steps from Basic Unique Device Identification-DI assignment to Notified Body confirmation—the system ultimately fosters a safer and more transparent environment for patients and healthcare providers across the EU/EEA.