Recently, several standards were added to the list of harmonized European standards for medical devices and IVDs. The European Union (EU) has a long history of using harmonized standards, and the question often arises: What makes a standard harmonized?
A European Standard (EN) is harmonized when it is published in the Official Journal of the European Union and associated with an EU Regulation or Directive.
Use of harmonized standards is voluntary, and no justification is required if other standards or guidelines are used. However, harmonized standards generally represent the “state of the art” and are considered the most efficient means of demonstrating compliance with the General Safety and Performance Requirements (GSPRs).
Devices that comply with harmonized standards are presumed to conform to the relevant requirements of the EU MDR or EU IVDR.
In contrast, the use of applicable common specifications, for example, the common specifications for certain class D IVDs [CS for class D IVDs ] or MDR, Annex XVI products [CS for MDR Annex XVI], is mandatory, and any deviation must be justified. The MDCG Guidance 2021-5 (July 2024) [MDCG 2021_5] provides additional information on the use of harmonized standards and common specifications.
With the publication of the Commission Implementing Decision (EU) 2025/2078, four additional standards were harmonized, under the European Medical Device Regulation (Regulation (EU) 2017/745 – MDR).
These standards include requirements and test methods for surgical clothing and drapes, medical face masks, and sterilizers for medical purposes.
- EN 13795-series: Surgical clothing and drapes – Requirements and test methods
- EN 14683: Medical face masks– Requirements and test methods
- EN 14180: Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing
Our Consulting team can support you throughout the conformity assessment process and assist with any compliance compliance concerning the application of harmonized standards.
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