IVDR Class C: The Written-Agreement Deadline Has Passed — What Rapid-Test Buyers Should Do Next

Published: Oct 17, 2026 · By WeHere Medical

On 26 September 2026, the European Union's extended transition period for legacy Class C in-vitro diagnostics reached its final gate: manufacturers still relying on an IVDD-era declaration of conformity had to hold a signed written agreement with an EU Notified Body. That date has now passed — and its consequences will show up in rapid-test quotations and tender documents through 2027.

Why one date matters so much

The IVDR (Regulation (EU) 2017/746) replaced the old IVDD and moved most in-vitro diagnostics away from self-declaration and into Notified Body assessment. To prevent sudden shortages, the EU adopted Regulation (EU) 2024/1860, which extended transition periods — but attached class-specific conditions and hard deadlines to each extension. For a legacy device to keep its extended market access, the manufacturer must:

continue to comply with the IVDD, with no significant change in design or intended purpose;
operate an IVDR-compliant quality management system by 26 May 2025;
lodge a formal application with a Notified Body by the class deadline; and
sign a written agreement with that Notified Body by the class deadline.

The schedule by class:

Class D and devices covered by an IVDD Notified Body certificate: application by 26 May 2025, agreement by 26 September 2025 — market access until 31 December 2027.
Legacy Class C, previously self-declared: application by 26 May 2026, agreement by 26 September 2026 — market access until 31 December 2028.
Legacy Class B and sterile Class A: application by 26 May 2027, agreement by 26 September 2027 — market access until 31 December 2029.

These are not unconditional grace periods. A device that misses any one condition — including September's written-agreement deadline — cannot use the 2028 or 2029 dates. It either holds a full IVDR certificate, or it can no longer be placed on the EU market.

IVD rapid test production line

What it means for rapid-test buyers

Rapid tests — pregnancy and fertility, infectious disease, drugs of abuse — sit squarely in the affected range. Three practical effects are already visible:

Portfolio consolidation. Suppliers that submitted applications in time are now prioritising which legacy SKUs to carry through full IVDR certification before 31 December 2028. Lower-volume items are being discontinued rather than re-certified.
Stricter tender evidence. Buyers will increasingly be asked to confirm not just CE marking, but the exact certification route: IVDD legacy status (with application and agreement dates) or a full IVDR Notified Body certificate.
Longer qualification cycles. Notified Body capacity has been the sector's bottleneck for years. Certification timelines are measured in months, not weeks — so switching suppliers late is expensive.

A five-point checklist for procurement teams

Ask for evidence, not assurances. For each Class C SKU, request the Notified Body certificate — or, if the product is still in transition, the application reference and the signed agreement date.
Re-check classifications. The same test format can fall into different classes depending on analyte, intended use and whether it is self-testing. Misclassification is one of the most common causes of missed deadlines.
Qualify a second source before you need it. Dual-source critical SKUs while the first supplier's certification is still in progress.
Write regulatory-change clauses into contracts. Certificate withdrawal or replacement, notice periods, re-registration support and documentation handover should all have a contractual home.
Plan for the Class B wave. The 2027 deadlines cover far more products by volume than Class C. Supplier due diligence started now prevents a scramble in 2028.

What about stock already in the channel?

The deadlines govern the placing of devices on the EU market. Products already placed on the market before the relevant date can generally continue to be made available, subject to the usual vigilance and traceability obligations. The exact position depends on the product's status and documentation — which is why buyers should ask manufacturers for a written regulatory statement per SKU rather than rely on general assumptions.

Don't wait for the revision to rescue legacy lines

The European Commission published proposals to revise the MDR and IVDR in December 2025, and the file is still moving through the legislative process. Industry associations broadly support simplification, but a proposal is not a certificate. Procurement plans should assume the current rules apply until the amended regulations are published in the Official Journal.

How WeHere supports distributors

WeHere Medical supplies IVD rapid tests — infectious disease, pregnancy and fertility, and drug-of-abuse screening — from ISO 13485-based production. For tender submissions, our regulatory team shares the current certification status of each SKU and the documentation your dossier requires, and we support labelling, IFU and packaging adjustments for the importing market. If you are re-tendering a rapid-test line in 2027, ask us for a regulatory pack covering the exact SKUs you plan to list.