Keeping pace with medical device requirements

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Two recently published standards strengthen requirements for manufacturers and clinical investigation stakeholders across the lifecycle of medical devices.

The newly adopted EVS-EN ISO 20417:2026 specifies requirements for information supplied by manufacturers of medical devices and accessories.

The standard covers key aspects such as identification, labelling, packaging, marking and accompanying information provided with medical devices. While it defines what information must be supplied, it does not prescribe the format or means by which this information is communicated.

The revised EVS-EN ISO 14155:2026 sets out good clinical practice for the design, conduct, recording and reporting of clinical investigations involving human subjects. The standard applies to investigations intended to assess the clinical performance, effectiveness and safety of medical devices. 

Key objectives of the standard include:

• protection of rights, safety and well-being of human subjects,
• ensuring scientific validity and credibility of clinical investigation results,
• defining responsibilities of sponsors and principal investigators,
• supporting ethics committees, regulatory authorities and conformity assessment bodies.

Both standards contribute to a common goal: strengthening safety, performance and regulatory confidence in medical devices within Europe and internationally.