2026 EU MDR 公告機構清單（投標證據）

Yes. Orbid AI is the current product brand (formerly MedStrato). Same company (Galaxias Inc.) and the same MedTech tender agent for manufacturer bid teams. Try the product at orbid.dev; long-form guides stay on medstrato.com.

As of mid-2026, approximately 45–50 notified bodies are fully designated under EU MDR 2017/745, compared to over 80 that were designated under the old Medical Device Directive (MDD). This reduction has created capacity constraints and longer certification timelines at many NBs. The complete and authoritative list is maintained in the European Commission’s NANDO database, updated in real time as designations are granted, extended, or withdrawn.

For Class IIb and Class III devices in 2026, expect 12–30 months from initial NB contact to certificate issuance. Class IIa devices typically take 9–18 months. The timeline varies by NB queue length, device type, and technical documentation quality. The Class III scrutiny procedure with the relevant Expert Panel adds an additional 30–90 days. Starting the process before your MDD certificate expires is essential.

An expired or missing EU MDR certificate typically results in automatic disqualification from EU hospital tenders. Since 2023–2024, most EU hospital procurement authorities — particularly in Germany, the Netherlands, France, and the Nordic countries — treat valid MDR certification as a pass/fail criterion. If your NB certificate lapses during an active tender period, you may be unable to respond to or fulfil framework contract obligations until renewal is complete.

Yes, manufacturers can transfer NB certificates to a different notified body, but the new NB must conduct its own full assessment of your technical documentation. This typically takes 6–12 months. The old certificate remains valid during the transfer period if renewal is managed correctly. Most regulatory teams prefer to maintain relationships with their original NB where possible to avoid transition complexity and delay.