New EU technical standards for medical devices: what manufacturers must review in 2026

Key data

If you manufacture or distribute medical devices in Europe and do not update your technical documentation to the new versions of harmonized standards, you may lose your CE marking. Without CE marking, you cannot sell in the European market. That is how direct the impact of Implementing Decision (EU) 2026/2479, published on 10 November 2026, which amends Decision 2021/1182 and updates the official list of harmonized technical standards applicable to medical devices under Regulation (EU) 2017/745.

What does this regulation establish?

Harmonized standards are European technical standards (EN standards, generally based on ISO standards) whose compliance automatically grants the so-called "presumption of conformity": if your product complies with the standard, it is presumed to comply with the essential requirements of Regulation (EU) 2017/745. If the standard is updated and you do not adapt your product and documentation, that presumption disappears.

This Decision updates the current versions of harmonized standards in seven technical areas:

The modified standard is Implementing Decision (EU) 2021/1182, which already contained the previous list of harmonized standards. The new Decision 2026/2479 replaces references to old versions of EN/ISO standards with updated versions in these seven categories.

Economic and operational impact

The impact is not a direct fine, but the economic consequences can be equally serious. Working with obsolete versions of harmonized standards exposes manufacturers to two concrete risks:

• Withdrawal of CE marking: Without valid CE marking, the product cannot be marketed in any of the 27 EU Member States.
• Prohibition of marketing: Competent authorities may order the withdrawal from the market of products that do not comply with updated standards.

At an operational level, adaptation involves real costs:

• Review and update of the product's technical files.
• Update of validation processes if regulatory changes affect testing or verification requirements.
• Update of technical documentation to the corresponding notified body.
• In some cases, repetition of tests or conformity checks under the new requirements.

The cost varies depending on the complexity of the product and the scope of changes introduced in each specific EN/ISO standard, but ignoring it can mean a complete halt to sales in Europe.

Who does it affect?

• Manufacturers of electro-medical equipment (ventilators, monitors, defibrillators, etc.) that market in the EU.
• Manufacturers of sterilization products and companies that use sterilization processes in their medical devices.
• Manufacturers of natural rubber latex male condoms.
• Manufacturers of washer-disinfectors for use in hospital and clinical settings.
• Manufacturers of small-diameter connectors for liquids and gases in healthcare applications.
• Companies that conduct or sponsor clinical research with medical devices for human beings.
• Manufacturers of any medical device subject to biological evaluation (products in contact with tissues or body fluids).
• Distributors and importers that market in Europe products from third-country manufacturers: they must verify that their suppliers have updated the documentation.
• Notified bodies that certify the conformity of these products.

Practical example

A Spanish manufacturer of electro-medical equipment (for example, vital signs monitors for ICU) has its CE marking based on compliance with the previous version of the harmonized EN standard applicable to electro-medical equipment, referenced in Decision 2021/1182.

With the publication of Decision 2026/2479, the version of that standard is updated. The manufacturer must:

1. Identify exactly what has changed between the previous version and the new version of the EN standard applicable to its product.
2. Assess whether these changes affect the tests, design requirements or documentation of its technical file.
3. Update the technical file and, if necessary, repeat conformity tests.
4. Notify the changes to its notified body if the product is class IIa, IIb or III.

If it does not carry out this process and competent authorities detect that the product is being marketed under an obsolete standard, they may order its withdrawal from the European market, with the economic and reputational cost that entails.

What should companies do now?

1. Identify if your product falls into one of the seven affected areas: sterilization, clinical research, latex condoms, biological evaluation, washer-disinfectors, electro-medical equipment or small-diameter connectors for liquids and gases.
2. Locate the specific EN/ISO standards referenced in the new Decision 2026/2479 that apply to your product and compare with the versions you have in your current technical file.
3. Review the technical file to determine whether the changes introduced in the new versions of the standards affect tests, design, materials or processes of your product.
4. Update validation processes and technical documentation if regulatory changes require it.
5. Communicate the changes to the corresponding notified body if the product requires third-party intervention for its certification (classes IIa, IIb, III).
6. If you are a distributor or importer, request written confirmation from your supplier manufacturers that they have updated their documentation in accordance with the new Decision.

The risk of not acting is concrete: loss of CE marking and prohibition of marketing in the European market.

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_202602479