Is ISO 13485 Certification Acquisition Mandatory?

Is ISO 13485 Certification Acquisition Mandatory?

The author frequently receives consultancy requests for ISO 13485 certification acquisition support from medical device startup companies and other organizations. However, it must be stated clearly: ISO 13485 certification acquisition is not mandatory in Japan, the United States, or Europe.

That said, in some countries, ISO 13485 certification is stipulated as a condition for medical device approval applications, so caution is warranted.

Quality Management System Requirements across Jurisdictions

In Japan, it is sufficient to construct and operate a quality management system (QMS) that complies with the Medical Device Quality Management System Ordinance (QMS Ordinance). In the United States, it is sufficient to construct and operate a QMS that complies with 21 CFR Part 820 Quality System Regulation (QSR) and similar regulations. In Japan, if an ISO 13485 certification is obtained, the on-site inspection during product approval application may be reduced (or exempted), providing real merit to certification acquisition.

In Europe, too, ISO 13485 certification acquisition is not mandatory. This is because the European CE marking system is based on self-declaration. Manufacturers may simply self-declare compliance with EN ISO 13485 in a Declaration of Conformity document. However, most medical devices classified as Class III (high-risk) or Class IIb (moderate-risk) require certification from a third-party certification body (Notified Body).

Treatment of International Standards across Jurisdictions

Japan: Incorporation into JIS Standards

In Japan, international standards such as ISO/IEC are incorporated into JIS (Japanese Industrial Standards) before being adopted in ordinances and fundamental requirement standards. The QMS Ordinance revised in 2021 is based on JIS Q 13485:2018. This approach has resulted in substantial alignment between the international standard ISO 13485 and Japan’s regulatory requirements.

United States: Gradual Alignment with International Standards

In the United States, third-party certification to ISO standards has historically received little attention from both public and private sectors and is not a mandatory requirement for FDA audits or medical device approval applications. However, the FDA may designate ISO/IEC standards as Consensus Standards in certain contexts. The FDA has announced that it will harmonize the QSR with ISO 13485 and revise it as the Quality Management System Regulation (QMSR). This represents a significant regulatory shift that has been progressing through 2024 and into 2025.

Nevertheless, the FDA has historically refrained from formally recognizing ISO 13485 as a Consensus Standard. Consequently, the practice of ISO 13485 certification among US medical device manufacturers is not as prevalent as in Japan or Europe.

Europe: Incorporation into EN Standards and the Role of Annex ZS

In Europe, ISO/IEC standards are incorporated into EN ISO/IEC standards (EN standards), analogous to how international standards are incorporated into JIS standards in Japan. “EN” stands for “European Norm,” and “Norm” refers to standards to be achieved. Although international standards generally cannot be modified in their substantive text or appendices by individual countries, EN standards may be accompanied by an EU-specific annex called Annex ZS (or Annex ZA).

Annex ZS contains information explicitly stating whether compliance with the relevant EN standard constitutes compliance with EU regulatory requirements such as the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). In some cases, Annex ZS also specifies the differences between EN standard requirements and MDR/IVDR regulatory requirements. For compliance with EU MDR and IVDR, verification of Annex ZS in the EN standard is critically important. Compliance with EN ISO 13485 alone is insufficient.

The Role of Harmonized Standards in the MDR (European Medical Device Regulation)

Definition of Harmonized Standards and Requirements

The EU Medical Device Regulation (MDR), which entered into force on May 26, 2021, states that if a medical device complies with a European harmonized standard (a national standard adopted by the device in accordance with the harmonized standard) or a Common Specification (CS), then it is presumed to comply with the General Safety and Performance Requirements (GSPR).

A critical point for manufacturers in demonstrating compliance with GSPR is that when an applicable European harmonized standard exists, its use is virtually mandatory. Manufacturers must determine whether an applicable harmonized standard exists by consulting the list of European harmonized standards published by the European Commission.

Adoption of ISO 13485 as an MDR Harmonized Standard

On January 4, 2022, nine new standards were designated as MDR harmonized standards, and EN ISO 13485:2016 was formally added to the MDR harmonized standards list. This occurred five years after MDR implementation, representing a significant impact on industry. Prior to January 2022, compliance with ISO 13485 did not directly presume MDR compliance, requiring manufacturers to combine EN ISO 13485 with other harmonized standards (such as specific risk management or software standards).

As of 2025, the number of harmonized standards designated under MDR has expanded to over 30. Furthermore, the In Vitro Diagnostic Regulation (IVDR), which entered into force on May 26, 2022, also designates EN ISO 13485:2016 as a harmonized standard, playing an important role for IVDR-compliant medical device manufacturers.

Benefits of Harmonized Standard Compliance and Important Considerations

Voluntary Nature and the Benefit of Presumption

Compliance with European harmonized standards is designated as “Voluntary.” Manufacturers are not legally obligated to comply with harmonized standards. The benefit of compliance with a European harmonized standard is that “Presumption of conformity” with related regulatory requirements is established. This presumption simplifies the explanation of compliance to regulatory authorities and streamlines the certification process.

Alternative Approaches

Manufacturers may voluntarily select alternatives to European harmonized standards (non-harmonized EU standards, other international standards, or independently developed methods). However, when demonstrating GSPR compliance through alternative methods despite the availability of applicable European harmonized standards, manufacturers must satisfy the following conditions. Specifically, it is essential that manufacturers conduct a thorough investigation of the content of the applicable harmonized standard and demonstrate, based on evidence, that the safety achieved is equivalent to or exceeds that required by the harmonized standard.

This approach recognizes the possibility that emerging companies and innovative medical device manufacturers may adopt alternative quality management approaches. However, it is important to note that this significantly increases accountability to regulatory authorities.

Conclusion

While ISO 13485 certification acquisition is not legally mandatory in any of Japan, the United States, or Europe, regulatory authorities in these jurisdictions often have substantive expectations regarding certification. In particular, following the addition of EN ISO 13485 to the MDR harmonized standards list in 2022, compliance with ISO 13485 (or EN ISO 13485) has become virtually an essential requirement for medical device manufacturers targeting MDR/IVDR compliance.

For medical device companies pursuing international sales, accurately understanding the relationship between each country’s specific regulatory requirements and international standards is essential for establishing an efficient and compliance-excellent quality management system.