On October 6, 2026, the European Commission presented a proposal for a new regulation on European standardization, intended to replace the existing Regulation (EU) No. 1025/2012. Of particular interest to manufacturers: Harmonized standards are to become available free of charge. The key points:
- Standards referenced in the Official Journal, including harmonized standards, are to be available online free of charge in a readable, searchable and printable format
- Standards are to be developed faster: The goal is an average time until referencing of four years instead of around six, partly through deadlines for standardization requests
- The Commission is to be able to adopt common specifications as a fallback, for example if a requested standard is not delivered on time. Their use is to remain voluntary for companies, and the Commission is to withdraw them as soon as a suitable harmonized standard is available. The MDR already allows this anyway.
For medical device manufacturers, free access to standards such as EN ISO 13485 or EN ISO 14971 could make a noticeable difference. This is still a long way off: The European Parliament and the Council must first discuss the proposal. Changes are possible during the legislative process. The regulation is to apply six months after its entry into force.
Source: European Commission, Proposal for a Regulation on European Standardisation