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On 21 May 2025, the European Commission published its Omnibus IV simplification package, introducing a Regulation and a Directive to update numerous product-safety laws with a "digital by default" approach. Its core objectives are to streamline reporting and enhance legal certainty for businesses in the Single Market. The proposed changes not only move processes from paper to digital but also redefine how companies demonstrate compliance and meet product safety requirements. The proposals now enter the legislative process, requiring approval from both the European Parliament and the Council under the ordinary legislative procedure. Although this procedure generally takes around 18 months, the co-legislators may choose to fast-track the file. At this stage, it remains unclear whether such acceleration will occur. Debates might focus on the common specifications as a different method for meeting compliance requirements.
The proposals clarify reporting methods to reduce administrative burdens for all economic operators. Key measures involve eliminating paper-based declarations of conformity, adopting digital formats for instructions for use and introducing common specifications. Ultimately, this initiative aims to digitalise reporting obligations without compromising consumer protection and safety.
Proposed key changes include:
Another key development is the introduction of common specifications (“CS”), a set of technical requirements developed by the Commission as a fallback when harmonised standards are delayed, unavailable or insufficient. If a harmonised standard is later published, the CS will typically be repealed. So far, CS have been published in the medical device sector under the Medical Device and In Vitro Diagnostic Medical Device Regulations. In contrast, although the AI and Cyber Resilience Acts allow for future CS adoption, standardisation in these fields is still in progress, with no CS planned at present. Stakeholders stress that transparency in CS development is essential to preserve regulatory stability. Accordingly, the EU Commission has launched a public consultation (available here and here), open until 28 July 2025, to gather input on this approach.
The proposals will affect various industries subject to EU harmonised rules, including the machinery, batteries, and electric, electronic and radio equipment sectors. All economic operators across the value chain - including manufacturers, authorised representatives, importers and distributors - will need to comply with the updated rules.
Even though the measures are still at the proposal stage, the Commission has communicated a clear direction towards digitalised reporting and new compliance methods. While stakeholder feedback about common specifications potentially undermining the existing standardisation system might be considered and lead to adjustments during the legislative process, the fundamental impetus for modernising product compliance is strong and it is unlikely that the general direction of the proposal will change. Companies are thus well advised to consider what steps they need to take to comply with proposed changes, in particular regarding digital capabilities for managing DoCs and IFUs, and designating a reliable digital contact point. Firms should further ensure that mandatory paper-based safety information remains available, identify when DPP integration is necessary, review internal processes and data storage systems and ensure IFU formats are accessible and printable.
2 June 2025
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