Health Industry Standards (EN & ISO) are the lifeline of patient safety and product quality in Europe. Whether for medical devices, hospital management, or laboratory testing, these standards ensure compliance with the rigorous Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Setting the Global Benchmark for Care
In healthcare, there is no room for error. European Standards (EN) provide the harmonized technical requirements that manufacturers must meet to place products on the EU market. They cover the entire lifecycle—from design and risk management to clinical evaluation and post-market surveillance.
🩺 Medical Devices
Ensure regulatory compliance and quality management with EN ISO 13485.
⚠️ Risk Management
Systematically identify and control hazards throughout the product lifecycle using EN ISO 14971.
🔬 Clinical Laboratories
Guarantee competence and valid test results in medical labs with EN ISO 15189.
Essential Standards for the Health Sector
To obtain CE marking and ensure patient safety, these are the critical standards your organization needs:
| Standard | Title / Scope | Key Benefit |
|---|---|---|
| EN ISO 13485 | Medical Devices – QMS | Mandatory QMS for regulatory compliance. |
| EN ISO 14971 | Risk Management for Medical Devices | Identifies & controls risks to patients. |
| EN ISO 15223-1 | Symbols for Medical Device Labels | Standardizes safety information on labels. |
| EN 60601-1 | Medical Electrical Equipment | Ensures basic safety & essential performance. |
| EN ISO 14155 | Clinical Investigation | Good Clinical Practice (GCP) for device trials. |
| EN ISO 11135 | Sterilization of Health Products | Validation of Ethylene Oxide sterilization. |
Strategic Advantages of Compliance
Compliance is the barrier to entry for the European healthcare market.
- CE Marking: Harmonized standards (like EN ISO 13485) are the primary route to demonstrating conformity with the EU MDR and IVDR.
- Patient Safety: Rigorous risk management (ISO 14971) minimizes the likelihood of adverse events and recalls.
- Global Exports: ISO standards are recognized worldwide (MDSAP program), facilitating market access in the US, Canada, and beyond.
- Clinical Credibility: Adhering to GCP standards ensures your clinical data is accepted by Notified Bodies and regulators.
📥 Access Official Health Standards
Navigate the MDR/IVDR landscape with confidence. Download official EN & ISO documents directly from Genorma.
Frequently Asked Questions
Is ISO 13485 mandatory for medical devices?
It is not explicitly written in law, but it is the state-of-the-art standard for Quality Management Systems. Compliance with EN ISO 13485 provides a presumption of conformity with key requirements of the EU MDR.
How does EN 14971 help with the MDR?
The MDR requires manufacturers to have a risk management system. EN ISO 14971 defines the process for analyzing, evaluating, and controlling risks, making it the essential tool for meeting this legal requirement.
What about symbols on packaging?
Using symbols from EN ISO 15223-1 (e.g., “Sterile”, “Use By”, “Single Use”) allows you to label devices without translating text into every EU language, saving massive costs and ensuring clarity.
Explore Standards for Other Industries
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