On 6 October 2026, the European Commission proposed a revision of the current European standardisation system. With the new Proposal for a Regulation on European standardisation, the Commission aims at making sandards development more responsive and faster, while preserving its public-private partnership with European standardisation organisations.
Key changes in the European standards development system
The new Standardisation Regulation makes the standardisation system faster, more inclusive, and better coordinated. In particular, the revised framework addresses the following aspects:
- Reduce average development time of a standard with simpler process and broader expertise. With the current framework, developing standards takes on average six years. With the revised legislative text, the development will be shorten to four years. According to estimates, this will also lead businesses to save costs on compliance annually.
- More inclusive process. There will be rules to ensure participation and representation for small- and medium-sized enterprises, civil society, academia and public authorities in the standardisation process.
- Better access. The system will ensure free access to harmonised standards supporting EU law and policies. Following recent rulings from the European Court of Justice, the Commission wants to ensure free access to standards that form part of EU laws through the creation of repositories.
- Stronger global role. The revised text aims at improving coordination of the EU’s international standardisation strategy. The Commission is also proposing to create an Expert Centre on European Standardisation.
Next steps in the legislative process
The European Parliament and the Council of the European Union will analyse the proposed measures before their adoption and entry into force.
What are standards and why are harmonised standards important?
A standard sets agreed technical specifications for products, services, or processes. In Europe, standards are generally voluntary and developed by CEN, CENELEC, and ETSI, helping ensure safety, quality, interoperability, and easier access to the EU market.
Harmonised standards translate EU legal requirements into common technical specifications. Once cited in the EU Official Journal, they provide a presumption of conformity, helping reduce trade barriers, facilitate market access, and ensure safety and interoperability.
For any questions on compliance of medical devices and IVDs in the EU, UK, Switzerland, Canada, and US, contact us here or at mdlaw@obelis.net
References:
European Commission (2026). Factsheet – New Standardisation Regulation. Retrieved on 08/10/2026.
European Commission (2026). Questions and answers on the new Standardisation Regulation. Retrieved on 08/10/2026.
European Commission (2026). Commission adopts proposal to accelerate standards development and improve EU competitiveness. Retrieved on 08/10/2026.
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