EN ISO 13485: Relationship to the MDR/IVDR and strategic importance

EN ISO 13485: Dr. Kirsten Theiling, QMB at Metecon, explains when certification is required and why manufacturers, suppliers, and service providers benefit from certification.

In her previous post, Dr. Kirsten Theiling, QMB at Metecon, demonstrated that the legal requirements for a quality management system (QMS) depend significantly on the respective regulatory role. It became clear that while the MDR and IVDR impose extensive requirements on the QMS, they do not explicitly address the question of certification to EN ISO 13485.

The second part of this series of articles therefore takes a closer look at

• when EN ISO 13485 certification is mandatory,
• why voluntary EN ISO 13485 certification can be beneficial for manufacturers, and
• why suppliers, contract manufacturers, and service providers can benefit from EN ISO 13485 certification.

EN ISO 13485 and its relationship to the MDR/IVDR

Anyone looking for a specific reference to EN ISO 13485 in regulations (EU) 2017/745 (MDR) oder (EU) 2017/746 (IVDR) will search in vain. The regulations contain neither a direct reference to this standard nor an explicit requirement for certification to EN ISO 13485.

The first reference to the standard can be found in Article 8 of both regulations. It stipulates that compliance with the legal requirements is presumed provided that the QMS conforms to a harmonized standard. EN ISO 13485:2016/A11:2021 is currently the only standard harmonized with the regulations regarding the implementation of a QMS.

The standard can be applied by companies involved in at least one stage of the life cycle of a medical device or an in-vitro diagnostic medical device (IVD). These companies can therefore demonstrate with an EN ISO 13485 certification that their QMS meets the MDR or IVDR requirements.

The harmonization tables in Annexes ZA (harmonization with the MDR) and ZB (harmonization with the IVDR) indicate which regulatory requirements beyond the scope of the standard must be addressed in the QMS.

When do notified bodies expect an EN ISO 13485-certified QMS?

As soon as a manufacturer submits an application to its Notified Body for a conformity assessment in accordance with Annex IX or XI of the MDR/IVDR, it will find that the Notified Body expects an EN ISO 13485-certified QMS in certain cases. This expectation does not stem from an explicitly stated legal obligation but rather results from the conformity assessment procedure applied.

To understand this, one must take a closer look at MDR/IVDR Annexes IX and XI. Paragraph 2.3 of the respective annexes contains a further reference to a harmonized QMS standard. It states: "Where the manufacturer uses a harmonised standard … related to a quality management system, the notified body shall assess conformity with those standards…".

Since the only currently applicable harmonized standard is EN ISO 13485:2016/A11:2021, the Notified Bodies automatically require certification to this standard as part of the conformity assessment under Annex IX or XI.

The audit of the QMS based on EN ISO 13485 is therefore conducted by a certification body accredited for this purpose. The issued EN ISO 13485 certificate is valid for three years; this is specified in EN ISO/IEC 17021-1:2015, Section 9.1.3.2.

Class I/Class A manufacturers: Application of EN ISO 13485

Manufacturers of Class I medical devices and Class A IVD manufacturers may place their products on the market without involving a Notified Body. There is no formal EN ISO 13485-certification requirement for these manufacturers.

At the same time, the obligation to establish and maintain an effective QMS that meets the requirements of the MDR/IVDR remains in full force. Since the MDR and IVDR came into effect, Competent Authorities have significantly increased the number of audits performed at Class I/Class A manufacturers.

In this context, a QMS certified to EN ISO 13485 can be advantageous for manufacturers, as the standard contains detailed specifications for QM processes and helps to document processes in a traceable manner, to clearly define responsibilities, and to minimize risks.

Application of EN ISO 13485 by suppliers and service providers

Pursuant to Article 10(15) of the MDR/IVDR, manufacturers are required to register information regarding companies that perform activities related to the design or manufacture of their products in the European database EUDAMED. Since manufacturers must ensure and demonstrate the safety and performance of their products, they must contractually stipulate compliance with specific QMS requirements with their suppliers and service providers. In the case of an EN ISO 13485 certification, this is also a requirement for outsourced QM processes that may affect product conformity (clause 4.1.5).

Furthermore, MDR/IVDR Annex VII Section 4.5.2(a) stipulates that Notified Bodies must assess, as part of the evaluation of the manufacturer’s QMS, whether additional audits of suppliers or subcontractors are necessary. The costs of these audits are generally borne by the manufacturers.

In practice, a significant increase in such supplier audits has been observed since the MDR/IVDR came into force. For suppliers and service providers, this means that their own quality management system is coming under increased scrutiny.

In this context, a certification to EN ISO 13485 can provide suppliers and service providers with:

• a competitive advantage, as many manufacturers prefer to work with certified partners,
• a lower likelihood of audits by their customers’ Notified Bodies,
• greater confidence in the company on the part of manufacturers and Notified Bodies, and
• a reduction in liability risk due to lower error rates and better documentation.

Many manufacturers now specifically prefer partners with a certified QMS to minimize regulatory risks along the supply chain.

What are the additional benefits of voluntarily achieving EN ISO 13485 certification?

In summary, there are additional benefits of an EN ISO 13485 certification for manufacturers, suppliers, and service providers:

• Customer requirements are systematically reviewed, enabling higher customer satisfaction.
• The certification demonstrates a strong commitment to the safety and quality of medical devices or their components.
• Risk-based decision-making processes, optimized workflows, and clearly defined responsibilities can lead to cost savings.
• Liability and quality risks are minimized through reduced error rates and better documentation; in the event of a claim, there is greater legal certainty.
• Company knowledge is systematically documented, which facilitates onboarding and prevents knowledge loss.

Strategic considerations for a voluntary ISO 13485 certification

Even if there is no formal obligation, certification can make sense from a strategic perspective. This applies in particular to:

• Manufacturers with a growing product portfolio or an international market focus,
• Companies that regularly expect audits by regulatory authorities, manufacturers, or Notified Bodies,
• suppliers and service providers with critical development or production responsibilities.

In addition to regulatory compliance, the certification contributes to structured process design, improved documentation, and the preservation of organizational knowledge.

Conclusion

EN ISO 13485 provides the framework for audit-ready quality management systems. At the same time, EN ISO 13485 certification demonstrates compliance with the legal requirements of the MDR/IVDR. For companies, therefore, the question is not only about legal necessity but also about strategic benefit within their own regulatory and organizational environment.

How Metecon supports

Metecon supports manufacturers, suppliers, and service providers in the strategic evaluation of certification decisions, in the implementation and further development of quality management systems, and in the preparation and support of audits by Competent Authorities, suppliers, and Notified Bodies.

Would you like to conduct a thorough assessment of your QMS and audit strategy?
We are happy to provide an initial consultation—non-binding and free of charge.