European standardization represents an important cornerstone in the context of the New Approach or New Legislative Framework. A harmonized standard (hEN) is, according to Art. 2 No. 1 c) of the Standardization Regulation (EU) 1025/2012, a ...
... European standard adopted on the basis of a mandate from the Commission for the implementation of Union harmonization legislation.
When such harmonized standards are published in the Official Journal of the European Union, they give rise to a presumption of conformity with the essential requirements covered by the relevant harmonized standard when applied.
However, with the impact of the so-called James Elliott judgment of the ECJ of 27 October 2016 and the Global Garden judgment of the ECJ of 26 January 2017, the publication procedure of the references of harmonized standards in the OJEU has changed fundamentally. This poses corresponding challenges for the three European standards organizations CEN, CENELEC and ETSI.
The James Elliott ruling of the ECJ assigns the Commission a broader responsibility in connection with the examination and approval for publication of harmonized standards in the EU Official Journal. Accordingly, under Art. 10 (5) of the Standards Regulation (EU) 1025/2012, the Commission must check whether an hEN actually meets the essential requirements it covers in the context of the standardization mandate (mandate). In doing so, it now proceeds in a very formal manner:
- Only when the harmonized standard meets these requirements will it be listed in the EU Official Journal in accordance with Art. 10 (6).
Since the Commission is technically unable to match the original standardization mandate with the standardization results, it had in the past commissioned an international consulting firm (Ernst & Young) to act as a so-called HAS (Harmonized Standards) contractor. It selects and engages the HAS Consultants (formerly New Approach Consultants) to assess, in accordance with Article 10(5) of Regulation (EU) 1025/2012, the relevant standard to determine whether it actually meets the essential requirements it covers in relation to the referenced harmonization legislation. Only when this HAS assessment has been successfully completed will the respective tested harmonized standards be published in the EU Official Journal.
As a further consequence in connection with the Global Garden judgment, the Commission must clearly confer a presumption of conformity on a harmonized standard or, in the event of subsequent objection, restrict the presumption of conformity for the relevant sections of the standard or clearly withdraw the presumption of conformity from a harmonized standard.
The overall result of these circumstances is that, on the one hand, additional examination time is incurred for the HAS consultants during the examination and, on the other hand, standards are failed during the HAS assessment. In this respect, this process takes correspondingly longer than before the James Elliott ruling. This has recently led to a severe delay and thus to a backlog in the publication of hENs – although these standards have already been ratified and published by CEN, CENELEC and ETSI.
Furthermore, it is critical to note that in the new harmonization legislation of the recent past (e.g. Medical Devices Regulation 2017/745 - MDR) or new projects (e.g. Machinery Regulation), the Commission reserves the right to publish common specifications, e.g. in MDR 2017/745:
Without prejudice to Articles 1(2) and 17(5) and the time limit laid down in those provisions, where no harmonised standards exist or where the relevant harmonised standards are insufficient or where public health concerns need to be taken into account, the Commission may, after consulting the MDCG, adopt, by means of implementing acts, common specifications (hereinafter referred to as "common specifications") for the essential safety and performance requirements listed in Annex I, the technical documentation listed in Annexes II and III, the clinical evaluation and post-market clinical follow-up listed in Annex XIV, or the clinical investigation requirements listed in Annex XV. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
A similar passage is contained in the draft Machinery Regulation. It is unclear who is actually supposed to develop these common specifications. The first half-sentence in the above provision is piquant. Among other things, the fact that to date there are only very few harmonized standards listed under the MDR in the EU Official Journal is due to the complication of the publication procedure as described above.
Perhaps not all companies are aware, but the contract with the HAS Contractor expired at the beginning of 2022. The Commission had to launch a new RFP. In the meantime, the HAS Consultants had stopped working due to the contractless situation. As a last consequence, this led to the fact that only hEN were listed in the Official Journal, which had already passed the HAS assessment, and thus an additional congestion has been created in the period 04.02.2022 to 01.08.2022. Now the Commission has announced that the contract has been re-signed with the then HAS contractor Ernst & Young. With the announcement of the new contractor for the new period, projects will be processed in the following order:
- Documents received for the Formal Vote (FV);
- Documents received prior to or during the "Enquiry (ENQ)" stage;
- Any other documents on an ad-hoc basis such as documents with a "Working Draft (WD)" status or documents prior to publication and that have not been subject to a previous HAS Assessment. These HAS assessment requests are coordinated in advance with the appropriate project manager.
To facilitate the work, a document list assigned to the technical committees is provided that includes upcoming HAS assessments. However, this is not publicly available, which does not make it easy for users.
Thus, it will take some time to clear this backlog. It is recommended that all users of the standard take this into account. Accordingly, the respective situation of the applied standards should be highlighted in the technical documentation as part of the conformity assessment. The presumption of conformity is based only on the harmonized standards published in the EU Official Journal. For all other technical specifications, proof must be provided of how the essential requirements of the harmonization legislation applied in each case are met.
Overall, the European standardization strategy can thus be questioned very critically. If, for example, there are HAS assessments in the field of mechanical engineering, some of which took 18 months (!), then this is clearly too long. In addition, there were always different interpretations between the respective standardization bodies, the responsible HAS consultant and the EU Commission representatives or the Legal Service. In this context, a feedback mechanism for the final draft (content modifications lead to a positive HAS assessment and acceptance by the Commission) should urgently be introduced, otherwise negative HAS assessments are the result again and again and unnecessary loops are made.
Feel free to contact us if you have any specific questions or uncertainties!
Extract from the new publication (in German):
Loerzer, Michael: Product Compliance Management – Praxishandbuch für die Ermittlung, Umsetzung und Einhaltung von Produktkonformität, 1. Edition 2022, Austrian Standards.