Guaranteeing Safety, Quality & Innovation in Healthcare
Medical technology saves lives every day — and European standards make sure those technologies are safe, reliable, and effective.
The EN and ISO standards for medical devices and healthcare equipment ensure compliance with the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), protecting both patients and professionals.
At European-Standards.com, you can search and access official medical device standards through the interactive search tool below, powered by Genorma.
🔍 Search Medical Devices & Healthcare Equipment Standards
🩺 Key Areas Covered by Medical Device Standards
European EN and ISO medical standards cover the full life cycle of devices and equipment, from design to testing and market access.
Some essential areas include:
- EN ISO 13485: Quality management systems for medical device manufacturers.
- EN ISO 14971: Risk management for medical devices.
- EN ISO 10993: Biological evaluation of medical materials and biocompatibility testing.
- EN 60601 Series: Electrical safety and performance of medical electrical equipment.
- EN ISO 14155: Clinical investigation of medical devices.
- EN ISO 11607: Packaging and sterilization for medical products.
- EN ISO 15189: Laboratory quality and competence requirements.
Each standard helps companies achieve compliance, improve patient safety, and maintain product integrity throughout its use.
⚕️ Why These Standards Matter
Compliance with European and international standards is mandatory for any company wishing to market medical products in the EU.
Adopting these standards helps:
- Ensure patient safety and reliability of healthcare products.
- Meet EU MDR and IVDR requirements for CE marking.
- Improve manufacturing quality and traceability.
- Support innovation while maintaining safety and performance.
- Facilitate global market access and regulatory acceptance.
Following standards is not just about compliance — it’s about trust, reputation, and protecting human life.