Is EN 62366 harmonized?

In the world of medical device usability engineering, one question that often arises is whether EN 62366 is harmonized. This article aims to provide a comprehensive analysis of the topic, shedding light on the standards and regulations surrounding it.

Understanding EN 62366

EN 62366, also known as IEC 62366, is an international standard that specifies requirements for the usability of medical devices. It focuses on the design of user interfaces and interactions, aiming to minimize use-related hazards and improve overall user satisfaction. The standard outlines a systematic process for identifying, analyzing, and mitigating potential use errors. It covers a broad range of medical devices, including software, hardware, and combination products.

The Harmonization Process

Harmonization, in the context of standards, refers to the alignment of different national or regional standards to create a unified set of requirements. This helps facilitate trade, ensure product safety and quality, and enhance market access for manufacturers. In the European Union (EU), the process of harmonization involves the publication of harmonized standards in the Official Journal of the European Union (OJEU). Once a standard is harmonized, it becomes a presumption of conformity, meaning that manufacturers who comply with the harmonized standard are presumed to meet the essential requirements of the relevant EU legislation.

EN 62366 in the Context of Harmonization

While EN 62366 is widely recognized and adopted by many countries, it is not currently harmonized under the Medical Device Directive (MDD) or the new Medical Devices Regulation (MDR) in the EU. This means that compliance with EN 62366 alone is not sufficient to demonstrate conformity with the essential requirements of the MDD or MDR. However, it is still considered a valuable reference for medical device manufacturers in achieving compliance with usability engineering requirements.