New sterilization requirements for medical device manufacturers: what changes in 2026

Key data

If you manufacture or distribute medical devices in Europe, this regulatory update directly affects your ability to commercialize. Implementing Decision (EU) 2026/2481, published on 10 November 2026, modifies Implementing Decision (EU) 2021/1195 to update the harmonized standard applicable to the sterilization of products intended for healthcare assistance. This is not a minor change: compliance with this standard is what grants the presumption of conformity with the EU Medical Device Regulation. Without that presumption, your products may be excluded from the European market.

What does this regulation establish?

The harmonized sterilization standard establishes the technical requirements that must be met by sterilization processes for products intended for healthcare assistance. When a manufacturer complies with this standard, they automatically obtain the presumption of conformity with the essential requirements of the EU Medical Device Regulation, which greatly simplifies the certification and commercialization process.

This decision updates the previous reference standard, contained in Implementing Decision (EU) 2021/1195. The change means that the new harmonized technical requirements replace the previous ones, and manufacturers must review whether their current processes remain compliant or require adaptation.

Economic and operational impact

The impact of this update is not only technical: it has direct consequences on the operations and revenue of any medical device manufacturer operating in the EU.

• Risk of commercial blockade: Companies that do not adapt their sterilization processes to the new standard could see their product commercialization in the European market compromised. This can result in product withdrawal from the market or the inability to launch new product lines.
• Adaptation costs: Reviewing sterilization processes involves internal audits, possible investments in equipment or procedures, updating technical documentation and, in some cases, new validations by notified bodies.
• Impact on the distribution chain: Distributors are also affected, as commercializing products that do not comply with the updated standard can entail regulatory responsibilities.
• Competitive advantage for those who act quickly: Companies that adapt their processes before the competition will be able to maintain or expand their market share in Europe without interruptions.

Who does it affect?

• Manufacturers of reusable medical devices that require sterilization between uses.
• Manufacturers of sterile medical products that are commercialized with pre-use sterilization.
• Manufacturers of surgical instruments and hospital equipment subject to sterilization processes.
• Distributors of medical devices in the EU that commercialize products from third-party manufacturers.
• Notified bodies that certify the conformity of these products.
• Quality and regulatory managers in healthcare sector companies with presence in the European market.

Practical example

A Spanish manufacturer of reusable surgical instruments commercializes its products in Germany, France and Italy. Its sterilization process was validated and documented in accordance with the harmonized standard contained in Implementing Decision (EU) 2021/1195, which granted it the presumption of conformity with the EU Medical Device Regulation.

With the entry into force of Decision 2026/2481, the reference harmonized standard changes. If this manufacturer does not review and adapt its processes to the new technical requirements, it automatically loses the presumption of conformity. This means that, to continue commercializing in the EU, it would have to demonstrate conformity through other means, which involves greater documentary burden, possible additional audits by the notified body and risk of delays or distribution blockages.

The correct action is to immediately initiate an internal review of the sterilization process against the new technical requirements, identify gaps and plan the necessary adaptations before the previous standard becomes ineffective.

What should companies do now?

1. Identify if you are affected: Check if your products require sterilization (pre-use or between uses) and if your current conformity is based on the harmonized standard contained in Decision 2021/1195.
2. Review the new technical standard: Access the text of Implementing Decision (EU) 2026/2481 and analyze the new harmonized technical requirements against your current sterilization processes.
3. Perform a gap analysis: Document the differences between your current process and the new requirements. This analysis is the basis for planning the necessary adaptations.
4. Update technical documentation: Review and update technical files, validation procedures and sterilization records to reflect compliance with the new standard.
5. Coordinate with your notified body: If your product requires intervention by a notified body, inform them of the changes and confirm if new evaluations or audits are required.
6. Inform the distribution chain: If you are a distributor, verify that the manufacturers of the products you commercialize have updated their conformity with the new standard.

Official source

Consult complete regulation in official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202602481