The preferred means to demonstrate the competence of a notified body is the accreditation by the National Accreditation Body (NAB). In order to ensure that the notified bodies are accredited throughout Europe (EU, EFTA and Turkey) in a harmonised way, EA published the document on Accreditation for Notification Purposes (EA-2/17). The application of this document is mandatory for all NABs, when accrediting a conformity assessment body for the purpose of becoming a notified body. EA-2/17 also applies to bodies performing assessment and verification of constancy of performance under the Construction Products Regulation.
EA-2/17 was revised in April 2020. The main purpose of this revision was the definition of the so-called preferred harmonised standard(s) for the accreditation of notified bodies. That has been done for each Union harmonisation legislation and module, the specific conformity assessment procedure.
Within three years from publication, all accredited notified bodies shall comply with EA-2/17:2020.
But what happens, if a CAB seeking notification does not meet the requirements set out in EA-2/17: 2020 after the transition period in April 2023?
For this case, the Technical Management Board approved the following resolution (TMB Resolution 2022 (10) 01) in order to ensure a consistent and unified implementation of EA-2/17:
- The NAB shall withdraw (if necessary, after a suspension) any accreditation for those conformity assessment activities not based on the preferred standard after the deadline established by EA-2/17 (17th of April 2023) – this also applies in the case when the notifying and/or regulatory authority’s published requirement (see EA-2/17 §4.2) includes more harmonized standards than the preferred standard, because the NAB can implement the preferred standard for each regulation/directive and module; The only case when no sanction is required to be applied for the CABs accredited by a different standard is when the notifying and/or regulatory authority has published a requirement (see EA-2/17 §4.2), binding to the CAB, not to accept the preferred standard, but a different one, as far as, for an aligned Directive/Regulation/Conformity Assessment Module, the nationally appointed standard fits with table 3 of Annex B and the 1+ approach is applied accordingly.
- However, in case the CAB already applied for the preferred standard, but the accreditation procedure is not yet finalized by the deadline, the NAB can choose to suspend instead of withdrawing any accreditation for a different standard, during a limited period of time until the accreditation procedure is completed.
Another important issue was the witness activities during the assessment. This has been addressed in EA-2/17 Annex C. But what happens if the witnessing cannot be performed, but the CAB shall be accredited and notified?
The Technical Management Board approved the following resolution (TMB Resolution 2022 (10) 02) when the NAB accepts to postpone the witnessing and grant the accreditation under the condition that the CAB (notified body) makes sure that the NAB is able to witness its first customer:
- The witnessing shall be carried out within a maximum of 18 months after receiving the accreditation – if, during this period, the witnessing has not been carried out, then the accreditation for that conformity assessment activity will be withdrawn (first suspended, if necessary), since the NAB is not able to fully assess the continuing competence of the CAB for all the applicable requirements;
- Once the accreditation is withdrawn, the CAB may apply again, but the option of being accredited with postponing of the witnessing for after the first clients’ requests have been received, will not be available for a period of time of two years. The CAB can, however, apply again under the normal regime of accreditation after witnessing.
You find the TMB resolutions in EA-INF/17 https://european-accreditation.org/publications/ea-inf-17/
Useful links:
EA-2/17 EA Document on Accreditation for Notification purposes
EA Accreditation for Notification (AfN) Project – Report September 2021
Regulation (EC) No 765/2008 setting out the requirements for accreditation
Decision No 768/2008/EC on a common framework for the marketing of products