Whitepaper: A Comprehensive Guide to EU Medical Device Tracking Requirements

Understanding the regulatory timeline helps manufacturers anticipate what needs to happen by when. Below we outline the evolution of EU Medical Device Regulations and the schedule of UDI and EUDAMED implementation milestones.

Evolution of EU Medical Device Regulations (1990–2025)

• 1990s – 2000s: Directives Lay the Groundwork: The first Medical Device Directive (MDD 93/42/EEC) took effect in the 1990s, introducing essential requirements and the CE marking system for devices. It established some traceability and vigilance procedures – for example, defining Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN) in later amendments – but oversight remained somewhat fragmented across EU member states. Additional directives like the Active Implantable Medical Devices Directive (AIMDD) addressed specific high-risk device types (e.g. pacemakers) with traceability needs. However, under the old directives, no unified EU-wide database or standardized tracking system existed, leading to variances in how countries managed device information.
  
  
• 2017: EU MDR Adopted: In response to technological advances and some high-profile device safety issues, the EU adopted the new Medical Device Regulation in 2017, with a transition period until May 26, 2021 for full application. MDR 2017/745 represented the first comprehensive overhaul of EU device rules in decades. It replaced the MDD and AIMDD and introduced stricter requirements for clinical evidence, PMS, and traceability, including the requirement for Unique Device Identifiers on device labels and the creation of EUDAMED. MDR’s goal was a unified, rigorous standard across all EU countries, closing regulatory gaps and enhancing patient safety.
  
  
• 2020–2021: EUDAMED Development and Partial Launch: EUDAMED, mandated by the MDR (Article 33), was envisioned to go live by 2020. Development delays pushed this out. The first module (Actor Registration) became operational on a voluntary basis around late 2020. This allowed manufacturers and other actors to start registering and obtaining a Single Registration Number (SRN). Since then, technical development has continued on the remaining modules. As of mid-2025, three modules are active (Actor Registration, UDI/Device Registration, and Notified Bodies & Certificates) on a voluntary basis, and three modules are still pending (Vigilance, Market Surveillance, Clinical Investigations). An independent audit of the completed modules is expected by late 2025, after which the European Commission can formally declare EUDAMED fully functional.
  
  
• 2025–2026: Expected Go-Live and Mandatory Use of EUDAMED: According to the latest timeline, the Commission aims to have the core modules of EUDAMED ready and audited by mid to late 2025. Once the system is declared functional (through publication in the Official Journal of the EU), a six-month countdown begins. EUDAMED’s use will become mandatory 6 months after the official notification of full functionality. If notification comes by Q3 2025, that implies mandatory use of the Actor registration, UDI/Devices, Certificates, and Market Surveillance modules by Q1 2026.The Vigilance module is expected to follow with mandatory use by late 2026, after a separate audit.The final piece, the Clinical Investigations module, is slated for 2026–2027 development and will be audited along with the rest once ready.In summary, 2025–2026 is when EUDAMED stops being optional and becomes an enforced reality – all manufacturers will need to have their data in the database within that timeframe to place devices on the EU market.
  
  
• 2027 and Beyond: By 2027, the vision is to have all six modules fully operational. Some industry analysis even projects that certain device registration and certificate data might have extended transitional timelines (e.g. compliance for those modules by 2027–2029).However, the European Commission has urged industry not to count on further delays. Companies that procrastinated in the past now face an accelerated timeline – meaning now is the time to get on board with EUDAMED, well ahead of any hard deadlines. Being proactive will not only ensure compliance but also confer competitive advantages.

UDI Implementation Deadlines (2021–2027)

In addition to EUDAMED’s rollout, the MDR introduced a phased implementation of Unique Device Identification (UDI) on product labeling and, for certain devices, direct part marking. The compliance dates depend on device class (risk level):

• May 26, 2021: UDI marking became mandatory on the labels of Class III (highest risk) devices and implantable devices. From this date, the highest-risk devices had to bear a UDI carrier (barcode or RFID) on their packaging, and manufacturers needed to start assigning UDIs to these products.
  
  
• May 26, 2023: UDI carrier requirement extended to Class IIa and IIb devices (moderate/high risk). Also, for reusable Class III and implantable devices, direct marking of the device itself with a UDI became required (if the device is intended to be reprocessed and reused). This direct part marking ensures traceability even when such devices are separated from their packaging.
  
  
• May 26, 2025: UDI carrier requirement applies to Class I devices (lowest risk), meaning even low-risk devices and general supplies must have UDI barcodes on their labels by this date. In addition, direct marking for reusable devices extends to Class IIa and IIb devices (moderate risk reusables) by 2025.
  
  
• May 26, 2027: Class I reusable devices must bear direct UDI markings on the device itself by this date. This is the final milestone in the UDI implementation timeline, ensuring even the lowest-risk reusable tools have permanent identifiers.
  
  

These staggered deadlines gave manufacturers time to implement UDI across all product classes. By 2027, every medical device on the EU market should carry a UDI (on its label at minimum, and on the device itself if reusable). Compliance with these dates is critical – if a device is required to have a UDI and doesn’t, it cannot legally be placed on the EU market after the deadline. The UDI system is also fundamental to EUDAMED: Manufacturers must upload UDI data for their devices into the database (via the UDI/Device Registration module). Regulators and healthcare providers will use these identifiers to track devices in the field, so meeting the UDI deadlines has been a top priority for regulatory compliance teams since 2021.