New CE rules for sterilizers, boilers and hearing aids: what changes in 2026

Key data

If you manufacture steam sterilizers for medical use, stainless steel steam boilers or hearing aids and market them in the EU, you have an active obligation from 1 April 2026: to review whether your products continue to comply with the current harmonized standards. The Implementing Decision (EU) 2026/760 has updated the references to technical standards in these three categories, modifying the previous Decision 2021/1182.

The mechanism is straightforward: harmonized standards are the most efficient way to demonstrate that a product meets the essential requirements of applicable European directives. If the reference standard changes and your product remains certified under the previous version, you may lose the presumption of conformity and, with it, the right to maintain the CE marking.

What does this regulation establish?

Decision 2026/760 modifies Implementing Decision (EU) 2021/1182, which contains references to harmonized standards applicable to different categories of industrial and medical products in the European market.

The update affects exclusively three product categories, with their respective harmonized technical standards:

Compliance with these harmonized standards grants the manufacturer the presumption of conformity with the essential requirements of the European directives applicable to each product. This is what enables CE marking and, therefore, marketing in the European single market.

When the Commission updates the references, manufacturers must verify whether the new version of the standard introduces technical changes that affect their product. If so, they must update their technical documentation and, where applicable, repeat the conformity assessment with the corresponding notified body.

Economic and operational impact

The impact is not abstract regulation: it has direct consequences on the ability to sell in Europe. Affected manufacturers must assume the following costs and operational burdens:

• Internal technical review: Analysis of whether the product meets the requirements of the new version of the harmonized standard. It may require additional testing or design review.
• Update of technical documentation: The product's technical file must reflect compliance with the updated standard, not the previous version.
• New conformity assessment: If the standard introduces substantial changes, it may be necessary to repeat the process with the notified body, with the associated economic and time costs.
• Risk of commercial paralysis: If the manufacturer does not update its compliance and continues to market under the previous standard, it may face the impossibility of accessing the European single market.

The cost of inaction far exceeds the cost of adaptation. Loss of CE marking is equivalent to loss of access to the European market for that product.

Who does it affect?

• Manufacturers of small steam sterilizers for medical use marketing in the EU and using harmonized standards to accredit their CE compliance.
• Manufacturers of stainless steel steam boilers subject to applicable European directives for this type of pressure or industrial equipment.
• Manufacturers of electroacoustic hearing aids operating under European directives on medical devices or audio equipment and must maintain CE marking.
• Quality and regulatory compliance managers (Quality Managers, Regulatory Affairs) in companies in the aforementioned sectors.
• Notified bodies that perform conformity assessments for these products and must apply the updated standards.
• Importers and distributors in the EU marketing these products under their own responsibility and must verify that manufacturers have updated their compliance.

Practical example

A Spanish manufacturer of small steam sterilizers for dental clinics has its product certified under the harmonized standard referenced in Decision 2021/1182. With the entry into force of Decision 2026/760 on 1 April 2026, the reference to that standard has been updated.

The manufacturer must do the following:

1. Identify what the new version of the harmonized standard referenced for medical sterilizers in Decision 2026/760 is.
2. Compare the technical requirements of the new version with those of the previous version under which it certified its product.
3. If there are relevant technical changes, update the product design or processes to comply with them.
4. Update the product's technical file with the new regulatory reference.
5. If the conformity assessment requires intervention by a notified body, initiate that process to avoid interrupting marketing.

If the manufacturer does not act and continues to market the product with technical documentation based on the previous standard, it loses the presumption of conformity with the essential requirements of the applicable directive, which may result in the withdrawal of CE marking and the inability to sell in the European single market.

What should companies do now?

1. Identify if your product is in one of the three affected categories: small steam sterilizers for medical use, stainless steel steam boilers or electroacoustic hearing aids.
2. Locate the new version of the applicable harmonized standard referenced in Decision 2026/760 for your product category.
3. Compare the new standard with the previous version under which your product is certified. Analyze whether there are technical changes that affect design, materials, testing or documentation.
4. Update the product's technical file to reflect compliance with the updated standard, including the new regulatory reference.
5. Contact your notified body if the update requires a new conformity assessment. Do this as soon as possible to avoid delays that could halt marketing.
6. Review the EU Declaration of Conformity of the product to ensure it references the correct and current standards.
7. Communicate the changes to importers and distributors in the EU marketing your product, so they have access to updated documentation.

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_202600760