FDA QMSR and EU EUDAMED Are Now in Force: 2026 Regulatory Milestones for Medical Device Exporters

The first half of 2026 delivered the two most consequential regulatory handovers of the decade for the medical device industry. In the United States, the FDA’s Quality Management System Regulation (QMSR) formally replaced the Quality System Regulation (QSR) on February 2, 2026. In the European Union, EUDAMED — the centralized database behind the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) — crossed from voluntary to mandatory use on May 28, 2026.

Neither change is a paperwork formality. Both reshape what a compliant supplier looks like: how factories run their quality systems, how devices are registered and traced, and what procurement teams should verify before signing the next supply agreement. Here is a practical recap — and the deadlines that still lie ahead in the second half of 2026.

1. United States: The QSR Is Gone — the QMSR Is the Law

The final rule amending 21 CFR Part 820 was published on February 2, 2024, giving manufacturers a two-year runway. Since February 2, 2026, the regulation is titled the QMSR, and its foundation is no longer the FDA-authored QSR text: the agency has incorporated ISO 13485:2016 by reference, together with Clause 3 of ISO 9000:2015 for definitions. Where a clause of ISO 13485 conflicts with the FD&C Act or its implementing regulations, the FD&C Act prevails.

The QMSR also makes risk management an explicit regulatory expectation, and it preserves the FDA-specific requirements that do not exist in ISO 13485 — for example, complaint files and the records obligations of 21 CFR 820.35, which apply even to device categories that are otherwise exempt from CGMP requirements.

Inspection practice changed on the same day. FDA began using its updated Inspection of Medical Device Manufacturers Compliance Program (7382.850) and retired the Quality System Inspection Technique (QSIT) along with the previous programs 7382.845 and 7383.001.

What exporters should internalize: an ISO 13485 certificate does not exempt a manufacturer from an FDA inspection, and it never replaced the FDA-specific obligations. For buyers, the message is to look past certificates and audit the substance: documentation mapped to the ISO 13485 structure, staff trained on QMSR terminology and risk-based thinking, and demonstrable complaint-handling and records controls.

2. European Union: EUDAMED Is Now Mandatory — Module by Module

The gradual roll-out mechanism created by Regulation (EU) 2024/1860 finally bore fruit. By Commission Decision (EU) 2025/2371, published in the Official Journal on November 27, 2025, the Commission confirmed that four EUDAMED modules are fully functional. Six months later — on May 28, 2026 — their use became mandatory under both the MDR and the IVDR:

Actor Registration — manufacturers, authorised representatives and importers must register and hold a Single Registration Number (SRN) before placing devices on the EU market. Without an SRN, downstream EUDAMED actions cannot proceed.
UDI/Device Registration — devices whose first unit is placed on the market on or after May 28, 2026 must be registered in EUDAMED before that first placement. Devices already on the market that will continue to be supplied must be registered by November 27, 2026 (12 months from the Official Journal notice).
Notified Bodies & Certificates — notified bodies must register every MDR/IVDR certificate issued from May 28, 2026 onward, and upload existing (legacy) certificates by May 27, 2027.
Market Surveillance — competent authorities now coordinate cross-border cases through EUDAMED.

The remaining modules — Vigilance and Clinical Investigations/Performance Studies — are still under development, so national procedures continue to apply in those areas for now.

The practical consequence: EUDAMED data is public. Registration records, UDI-DIs, certificates and economic-operator details can be consulted by distributors, importers and hospital buyers. Data consistency — labels vs. registration vs. certificates vs. Declarations of Conformity — is now effectively a public showcase, and discrepancies are easy to spot.

3. The IVDR Transition Clock Is Still Running

For IVD manufacturers and buyers of diagnostic-related consumables, the transitional deadlines under Regulation (EU) 2024/1860 remain the dominant planning factor:

Legacy IVD class	May be placed on the market until	Condition example
Class D	31 December 2027	application lodged with a notified body
Class C	31 December 2028	self-declared Class C manufacturers had to lodge an application by 26 May 2026
Class B & Class A (sterile)	31 December 2029	application deadline 26 May 2027

Note: EUDAMED obligations apply in parallel to these extensions — a legacy IVD that continues to be supplied must still meet its EUDAMED registration deadlines.

4. An H2 2026 Checklist for Exporters and Buyers

Confirm SRN status for every legal entity in your supply chain — manufacturer, authorised representative, importer.
Segment your EU portfolio by UDI/DEV deadline: which SKUs were first placed after May 28, 2026 (registered already?), and which continuing products must be registered by November 27, 2026.
Map your QMS documentation to the QMSR/ISO 13485 structure and verify the FDA-specific additions (complaint files, records) are explicitly covered.
Rehearse an inspection under the 7382.850 process — updated terminology, risk-based walkthroughs, opening-meeting discipline.
Run a data-consistency audit across EUDAMED records, product labels, DoCs and notified-body certificates.
For IVD lines, confirm notified-body capacity now; notified-body backlogs are the binding constraint on the 2027–2029 IVDR deadlines.

5. What This Means for Buyers of Disposable Medical Consumables

For procurement teams, 2026’s milestones compress into one idea: supplier qualification is now data-driven. Wehere Medical has operated an ISO 13485:2016-certified quality management system for years — the same standard that now anchors the FDA’s QMSR — across three own factories and a network of more than 45 audited partner factories, covering 2,500+ products shipped to 50+ countries. Our regulatory team supports partners with the documentation that matters under the new framework: CE technical files under MDR, consistent labelling and UDI data, and audit-ready QMS records — with 24-hour response on active inquiries.

The direction of travel on both sides of the Atlantic is convergence: one quality vocabulary (ISO 13485), one data backbone (UDI/EUDAMED), and public transparency. Exporters that close their gaps in 2026 will enter 2027 with fewer audit surprises, faster registrations and a procurement story that is measurably easier to verify.