As part of BSI Regulatory Services, Medical Devices commitment in maintaining IVDs manufacturers up to date on the EU regulatory framework developments, we issue this communication in regard of the rollout of EU Reference Laboratories and oversight of Class D IVDs in Europe.
In 2023 Commission Implementing Regulation (EU) 2023/2713 was published designating five EU reference laboratories (EURLs) for performance verification and batch testing of certain Class D Devices.
On 16 December 2025, (EU) 2025/2526 amending Implementing Regulation (EU) 2023/2713 has been published to designate new EU Reference Laboratories (EURLs) for high-risk (Class D) in vitro diagnostic medical devices. Date of application is 1st May 2026.
The document designates European Union reference laboratories for in vitro diagnostic medical devices intended for the detection of markers of parasite infection and detection of blood grouping markers.
EURLs for devices intended for detection or quantification of markers of parasite infection:
- Instituto de Salud Carlos III, Madrid, Spain.
- Consulting Químico Sanitario SLU, Madrid, Spain.
EURLs for devices intended for detection of blood grouping markers:
- EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Langen, Germany.
- Consulting Químico Sanitario SLU, Madrid, Spain.
- RISE Research Institutes of Sweden AB, Borås, Sweden.
Similarly to (EU) 2023/2713, Class D devices belonging to parasite infection and blood grouping categories are expected to undergo performance verification and batch testing by the EU Reference Laboratory in accordance with Article 100(2). points (a) and (b), of the IVDR.
Performance verification, as part of initial conformity assessment, will only be applicable to devices where applications are lodged with a Notified Body after 1st May 2026 as per Art 2.3, meaning:
- Class D Devices under application or already certified per IVDR, prior to 1 May 2026, will not require EURLs involvement in the initial conformity assessment for CE marking.
- Batch verification testing will be applicable from 1 May 2026 for all Class D devices that are already certified or undergoing conformity assessment.
To date, the designated EURLs for Class D IVDs are those for the detection or quantification of markers of hepatitis or retrovirus infection, herpes virus infection, bacterial agents, respiratory virus, parasite infection and blood grouping.
Note that Class D IVDs that fall outside of the scope of these designated EURLs will continue to be assessed by the Notified Body, through alternative means: no EURLs are involved in the conformity assessment for these devices, at the moment.
BSI will be actively transitioning Class D devices into the new EURLs framework. BSI will continue to work towards smooth and timely transitions into EURLs throughout 2026, while developing a consistent approach for performance verifications and batch tests on Class D devices. Meanwhile, BSI is committed to exploring ways to mitigate the risk of certifying Class D devices without independent laboratory verification and without reducing the level of scrutiny advocated under IVDR.
How can I be prepared?
IVD Manufacturers will not have a direct contract/agreement with an EURL, as these are independent organizations that will directly liaise with BSI. BSI has already implemented the necessary processes to engage with the designated EURLs for all Class D devices. In preparation of the implementation of EURLs oversight, IVD manufacturers should follow the below steps, depending on the applicable scenario:
- If you intend to transition to the IVDR your Class D IVDs belonging to the latest designated EURLs categories, apply as soon as possible with BSI. If you apply before May 1, 2026, Performance Verification is still required, but can happen later in the certification cycle.
- For devices belonging to the latest designated EURLs categories, if you will apply with BSI after May 1, 2026, you need to ensure compliance to any applicable CS for EURLs Performance Verification and Notified Body assessment. Batch testing criteria will be confirmed before certificate is issued to enable the batch release activity by the EURLs.
- If your Class D IVD is undergoing conformity assessment or it is already certified by BSI through alternative means under the IVDR, ensure compliance to any applicable Common Specifications (CS) as these will feed into the EURL test plan and be prepared to discuss batch release schedule for your Class D devices.
- If your Class D device falls into a category for which an EURL has not yet been designated, BSI will continue to provide conformity assessment services and batch release activities by the alternative means already in place.
- Legacy Annex II List A IVDs (certified under 98/79/EC) that are eligible to be placed on the EU market, as per the conditions of amendment (EU) 2024/1860, will undergo batch verification activities under the regime of the Notified Body responsible for their appropriate surveillance; while the EURLs provisions will apply to the IVDR devices as described above.
To anticipate compliance obligations and avoid delays, manufacturers should acknowledge the organisational requirements of EURL activities as defined in (EU) 2022/944.
Please note that:
- BSI clients with existing signed agreements that cover Class D IVDs will need to update their certification agreements to cover the EURL specifics of MDCG 2022-3, (EU) 2022/945 and (EU) 2023/2713 as amended. BSI will proactively reach out providing the updated agreements.
- Clients lodging new Class D applications will be provided with the updated certification agreement, as part of the application and certification process.
- Manufacturers already involved in the EURL transition plan are encouraged to continue complying as per (EU) 2023/2713. Manufacturers are reminded that Performance Verification activities will be performed before re-certification. If you are a BSI client, please contact your Scheme Manager to agree upon Performance Verification plan ahead of your certificate expiry date.
Where can I find additional information?
You can visit our IVDR dedicated webpage to access additional information and resources to support you, along with an IVDR transition guidance, timeline and Q&A. If you have additional questions, please email us at MedicalDevices@bsigroup.com.
Sincerely,
Alex Laan,
Head of the IVD Notified Body, Regulatory Services, BSI
Sara Fabi,
IVD Regulatory Lead, Regulatory Services, BSI
