IVDR Class D Is Fully Under EURL Oversight Now — Is Your Batch-Testing Process?

In December 2023, the European Commission designated the first EU Reference Laboratories for IVDR Class D devices under Commission Implementing Regulation (EU) 2023/2713, covering four categories that went operational on October 1, 2024. In December 2025, the Commission designated EURLs for two more — parasites and blood grouping — under Commission Implementing Regulation (EU) 2025/2526, operational since May 1, 2026. Every original high-risk category the Commission planned to cover now has a working laboratory behind it. Most manufacturers still talk about EURL involvement as something that happened once, at CE marking. It didn't. It is a standing testing obligation on every batch you make.

What EU Reference Laboratories actually do

Article 100 of the IVDR lets the Commission designate EU Reference Laboratories for the highest-risk in vitro diagnostics. For Class D devices assigned to a designated category, Article 48 routes conformity assessment through that laboratory: it verifies the manufacturer's performance claims against the common specifications and, once the device is on the market, tests batches on an ongoing sampling basis. A Notified Body still issues the certificate. The EURL is the technical check behind it — a second, independent test of whether the device performs the way the manufacturer says it does.

The distinction that trips people up: initial versus ongoing

Performance verification as part of initial conformity assessment only applies to applications lodged with a Notified Body after your category's EURL became operational. If your device was already certified, or already under review, before that date, you did not have to go back through EURL performance verification to keep the CE mark you have. That is a real relief for manufacturers who certified early — and it is also the fact that gets over-read. It applies to initial conformity assessment only. Batch verification is a separate, ongoing obligation under Regulation (EU) 2022/1107's common specifications, and it does not care when your certificate was issued.

• All six categories are live. Hepatitis/retrovirus infection, herpesviruses, bacterial agents transmissible via blood, and respiratory viruses since October 2024; parasites and blood grouping since May 2026.
• Batch testing is sampling-based, not exhaustive. MDCG 2022-3 rev.1 sets the framework EURLs and Notified Bodies use to schedule which manufactured batches get tested.
• The common specifications set the bar. Regulation (EU) 2022/1107 fixes the performance requirements — analytical sensitivity, specificity, and related parameters — each EURL tests against.
• Reports route through your Notified Body. Manufacturers do not submit batch data to the EURL directly; the Notified Body manages that relationship and the resulting certificate implications.

Class D conformity assessment used to feel like it ended at CE marking. It doesn't. Every batch you manufacture now has a testing obligation standing behind it, whether your certificate is five years old or five months old. Why batch verification is a release-process question, not a regulatory-affairs footnote

Where this actually shows up in your operating model

The manufacturers who handle this well treat EURL batch verification as a manufacturing release gate, wired into the same process that governs lot disposition — not as a compliance task that surfaces only when a Notified Body asks about it. That means knowing, before you manufacture, which category your device falls into, what your Notified Body's submission logistics look like, and what a failed or delayed batch test does to your shipping schedule. It is the same operating-model discipline that IVD regulatory and quality strategy work generally rewards: treat the regulation as a process to run, not a document to file. Devices that also carry a Notified Body and Certificates module obligation in EUDAMED add one more place batch-level data has to reconcile cleanly.

None of this requires a program rebuild. It requires treating EURL involvement as what it now is: a standing feature of Class D manufacturing, not a milestone you cleared once. Manufacturers who certified early and assumed the EURL relationship was behind them are the ones a routine Notified Body review will catch first.