EN ISO 14971:2019

Integration of International Standards into National Standards

In Japan, international standards such as ISO (International Organization for Standardization) are adopted as JIS (Japanese Industrial Standards) within the national standards framework. Similarly, in Europe, they are adopted as EN (European Norm).

International standards comprise normative content (requirements) that are legally binding and Annexes (supplementary materials) that provide additional information. When ISO member countries adopt international standards as national standards, they are not permitted to modify the text or Annexes. This preservation of the standard ensures international consistency and harmonization.

The only exception is that each country may add “Annex ZS,” which specifies country-specific requirements. This mechanism enables countries to maintain international harmonization while simultaneously addressing their unique regulatory requirements. Consequently, national implementation becomes both internationally consistent and domestically compliant.

EN ISO 14971:2019 and Recent Amendment Status

The latest EN standard corresponding to ISO 14971:2019, the international medical device risk management standard, is “EN ISO 14971:2019+A11:2021.”

This standard is recognized as a harmonized standard under both the EU MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), making it an essential standard for medical device commercialization in the EU market.

EN ISO 14971:2019 establishes requirements that are substantively equivalent to ISO 14971:2019. Amendment 11 (A11:2021), issued in 2021, introduced Annex ZS, which provides EU-specific implementation guidance.

Furthermore, EN ISO 14971 includes the following critical annexes:

• Annex ZA: Clarifies the relationship between MDR General Safety and Performance Requirements (GSPR) and the requirements of EN ISO 14971, enabling compliance personnel to align medical device development with both frameworks simultaneously.
• Annex ZB: Illustrates the relationship between IVDR General Safety and Performance Requirements and the requirements of EN ISO 14971, providing practical guidance for in vitro diagnostic device compliance.

These annexes serve as practical mappings that enable medical device manufacturers to simultaneously satisfy both MDR/IVDR requirements and ISO 14971 requirements, thereby supporting efficient regulatory compliance.

Key Differences from the 2012 Edition

EN ISO 14971:2012 contained “Contents Deviations (CD),” comprising seven substantive differences from ISO 14971. These differences introduced considerable complexity and ambiguity in medical device regulatory compliance across the EU market.

Difference Item	2012 Edition Content	Enhancement in Current Edition
1. Treatment of Negligible Risk	Susceptible to different interpretations	Completely aligned with ISO 14971:2019
2. Manufacturer Discretion in Risk Acceptability	Ambiguous provisions	Unified under clear criteria
3. Risk Reduction Expression Difference	“As far as possible” vs. “As low as reasonably practicable”	Unified under ISO standard terminology
4. Scope of Risk/Benefit Analysis Application	Limited applicability	Extended to all risk management activities
5. Discretion in Risk Control Measures	Unclear specifications	Explicit and unambiguous provisions
6. Discretion in Initial Risk Control Measures	Unclear specifications	Explicit and unambiguous provisions
7. User Information on Residual Risk	Restricted requirements	Enhanced and comprehensive requirements

In the current edition (EN ISO 14971:2019+A11:2021), these Contents Deviations have been completely resolved.

According to MED DEVICE ONLINE, a prominent medical device regulatory resource:

“The use of a section called ‘Contents Deviations’ is no longer part of the harmonized standard. In the previous version of EN ISO 14971:2012, substantial confusion existed regarding the use of this section, and errors within the cited ‘Contents Deviations’ created numerous compliance challenges for companies striving to meet regulatory requirements. Furthermore, disagreement among National Bodies (NBs) compounded the complexity. Consequently, EN ISO 14971:2012 failed to achieve its original intent of promoting safer and more effective medical devices compared to ISO 14971:2007.”

This clarification has significantly improved the consistency and clarity of medical device risk management practice within the EU. Organizations can now confidently implement risk management processes with greater transparency and operational efficiency, substantially reducing compliance ambiguity.

Relationship with JIS T 14971:2020

No differences exist between ISO 14971:2019 and JIS T 14971:2020. The Japanese medical device risk management standard establishes requirements fully equivalent to those of the international standard, achieving complete international harmonization. This alignment ensures that Japanese medical device manufacturers and regulatory stakeholders operate within a globally consistent framework.