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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

EU MDR

Four EUDAMED modules become mandatory on May 28, 2026

MedDevice Startups Staff · Dec 2 · 2 min read · Via European Commission EUDAMED overview

Commission Decision (EU) 2025/2371 appeared in the Official Journal on November 27, 2025 and started a six-month countdown. From May 28, 2026, four EUDAMED modules are mandatory rather than voluntary: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. Devices already placed on the market get until November 27, 2026 to finish their UDI and device registration entries.

The order of operations catches companies out. A manufacturer cannot register a device until it holds a Single Registration Number from actor registration, and a non-EU manufacturer needs its authorised representative registered as well. Basic UDI-DI and UDI-DI codes come from an issuing entity before any of that data can be uploaded. Each step has its own queue, so a company that starts in May 2026 will not finish in May 2026.

Questions & Answers

When does EUDAMED become mandatory for medical device manufacturers?

Four EUDAMED modules become mandatory on May 28, 2026 under Commission Decision (EU) 2025/2371, published in the Official Journal on November 27, 2025: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance.

What is the EUDAMED deadline for devices already on the EU market?

Devices placed on the market before May 28, 2026 have until November 27, 2026 to complete registration in the UDI and device registration module.

What does a startup need before it can register a device in EUDAMED?

An actor registration with a Single Registration Number for the manufacturer and, for non-EU companies, the authorised representative, plus Basic UDI-DI and UDI-DI assignments from an issuing entity for every device.

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