On September 17 and 18, 2025, a meeting of the EOTA Technical Board was held in hybrid mode. The OIB was represented by Elisabeth Bata. The main contents of the meeting can be found in our report.
Text Elisabeth Bata
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Publication of European Assessment Documents (EAD) in the Official Journal of the EU under Regulation (EU) No 305/2011 (CPR-2011)
The last publication of EADs in the Official Journal of the European Union (OJ) was in September 2025 and comprised 21 documents.
As of mid-September 2025, a total of 488 EADs – including various adaptations – had been published in the OJ. At that time, 99 further EADs were still scheduled for publication, 44 of which had already been released by the European Commission (EC) (“greenlight”).
A total of 697 EADs are available at EOTA level for issuing European Technical Assessments (ETAs). This includes those EADs for which the adoption procedure according to Annex II of the CPR-2011 has already been completed but which have not yet been published in the OJEU.
Impact of the new Regulation (EU) 2024/3110 (CPR-2024) on EOTA
As part of the negotiations with the European Commission (EC) on CPR-2024, various issues and their significance for EOTA were discussed in detail.
The most important conclusions can be summarized as follows:
- ETAs based on non-published EADs under the CPR-2011
European Technical Assessments issued on the basis of non-published EADs according to CPR-2011 will continue as ETA Requests from January 8, 2026 (Date of Applicability, DoA of CPR-2024).
The technical content of these ETAs can still be used.
However, the issuing of a Declaration of Performance and CE marking is not permitted.
- Further processing of EADs after the start of the last publication under the CPR-2011
In order not to interrupt the ongoing work process, the European Commission will continue to review EADs until the DoA – albeit with reduced staffing capacities. Manufacturers who express no further interest in continuing their procedure will be removed from the process.
- Follow.up on the implementation steps of CPR-2024
- Horizontal legal act to cover all AV systems:
The draft is based on the current AVCP framework and takes into account all product families listed in Annex VII and X of CPR-2024 as well as horizontal essential characteristics. EOTA has received and commented on the draft Delegated Regulation on Assessment and Verification Systems (AVS). The publication of the Delegated Regulation is expected before the DoA of CPR-2024. - Implementing act on the ETA format:
The document is currently undergoing inter-service consultation within the EC. A public consultation is planned before publication in the OJ and until the DoA.
- Horizontal legal act to cover all AV systems:
- ETAs issued after the DoA of the CPR-2024
The issuance of ETAs based on published EADs in accordance with the CPR-2011 is still possible after the DoA of the CPR-2024. The existing ETA format can continue to be used for this purpose.
For ETAs issued after the DoA on the basis of EADs cited under CPR-2024, however, the ETA format specified in the implementing act must be used.
This means that two parallel systems will exist after the DoA – one under CPR-2011 and one under CPR-2024.
- EAD procedure
The time period until publication of EADs developed after 2021 has been significantly shortened. However, a comprehensive assessment of all development phases – from registration to the work program, drafting and adoption to publication – remains necessary. In the context of CPR-2024, this timeframe is particularly important as ETAs can only be issued after publication of the underlying EADs. To further accelerate the process, a “proof of concept” for a 12-month fast-track procedure for EADs is currently being carried out within EOTA.
EADs in Step 9 (in accordance with Annex VI of CPR-2024) must in future cover all new requirements of CPR-2024 – in particular sustainability, product information, instructions for use, safety aspects and machine-readable content. This applies in particular to EADs that were not published under CPR-2011.
EADs that have already been technically adopted at EOTA level do not have to go through these steps again.
- EAD format
The Commission’s current focus until the end of September 2025 is on reviewing and preparing EADs for publication; the detailed discussion on the format has therefore been postponed for the time being.
The draft of the new EAD format (T06) was created on the basis of the current template. It is based on the previous structure and integrates additional elements such as general product information, instructions for use, safety information, machine-readable content and mandatory environmental features.
The draft was submitted to the Technical Board for comment and will subsequently be further revised.
