Quality management systems (QMS) define a common structure and core concepts for organizations to plan, do, check, and act (PDCA). In the medical device industry, the importance of the QMS has grown to ensure quality in developing, manufacturing, and distribution processes. A medical device QMS is a structured system that documents the procedures and processes implemented throughout the complete lifecycle of a medical device, from design and development to production and distribution to post-market surveillance. If specific processes (e.g., design, manufacturing, distribution) are outsourced, the manufacturer must demonstrate adequate control over these processes.

How the EU IVDR defines QMS requirements for IVD manufacturers

The IVDR Article 10(8) requires all manufacturers of IVDs to comply with all applicable requirements – including an effective QMS. There is no specific obligation to use the European harmonized standard “EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes,” but it typically serves as a basis for an IVDR-compliant QMS. The strong link between the QMS and requirements from MDR or IVDR is reflected in detail in the Z-Annexes (ZA, ZB) of this standard.

How and when QMS requirements in the IVDR apply to your device depends on how you are currently marketing your device. Typically, the following scenarios apply for IVD manufacturers:

• You are already marketing your IVDs on the EU market under IVDR. In this scenario, your QMS, as well as the Technical Documentation, must already comply with the applicable ISO 13485 and IVDR requirements.
• You intend to market your IVDs on the EU market under IVDR. In this scenario, your QMS, as well as the Technical Documentation, needs to demonstrate compliance with the applicable ISO 13485 and IVDR requirements before you submit your application to the notified body (Class A sterile, B, C, D) or sign the declaration of conformity (Class A).
• You are marketing your IVD on the EU market as a legacy device under IVDD. In this scenario, your QMS, as well as the Technical Documentation, must partly comply with the applicable ISO 13485 and IVDR requirements. This refers to post-market surveillance as well as vigilance, but also labelling and registration requirements (see MDCG 2022-8, Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC). 

Transitional provisions for legacy IVDs

On 9 July 2024, a new amendment ((EU) 2024/1860) to the MDR and IVDR was published, introducing new extended transitional provisions and specific obligations for certain IVDs (legacy devices). One of these new obligations is to implement a QMS in accordance with Article 10(8) IVDR by 26 May 2025, regardless of the IVD device class. The EC also states: “The documentation on the QMS needs to be part of the application for conformity assessment for any devices the manufacturer intends to transfer to the IVDR, and must be submitted by the relevant deadlines for applications to a notified body no later than 26 May 2025 for class D devices and for devices covered by an IVDD certificate, 26 May 2026 for class C devices and 26 May 2027 for class B and class A sterile devices.” 

In other words, the deadline to have a IVDR-compliant QMS is 26 May 2025 for Class D devices, which can be a significant hurdle for legacy IVDs that were “self-declared” as “general IVDs” per the IVDD but now fall under Class D per the IVDR (e.g., SARS-CoV-2, Malaria, Dengue fever, Treponema pallidum, Trypanosoma cruzi). For this class of IVDs, the IVDR-compliant QMS is also a prerequisite to lodge the application with the notified body by the same deadline of 26 May 2025. 

Even if you are not yet audited or lodging an application to notified bodies, you should have already conducted a gap assessment for your current QMS and updated the relevant QMS procedures. These changes in your QMS may also affect contracted partners, such as distributors.‍

What QMS practices must be followed to comply with IVDR Article 10(8)?

While there is no official interpretation for the required QMS level, the Q&A document “EXTENSION OF THE IVDR TRANSITIONAL PERIODS” from July 2024 provides some insight. 

Question 9 states that the QMS should be in a condition to “ensure that manufacturers gradually move towards full compliance with the IVDR requirements” and that “manufacturers must draw up the documentation on its QMS by this date (regardless of the device risk class under the IVDR).” In other words, even if the records created out of these QMS processes are not yet completely in place, the QMS process must show how these will be met. For example, for IVDR Article 10(8) e), you need to have a risk management procedure that describes the planning, initial risk analysis, risk analysis and mitigations, and the risk management report in line with ISO 14971. 

For IVDR Article 10(8) f), you must establish a performance evaluation procedure that describes how you will conduct scientific validity, analytical performance, and clinical performance to address the clinical evidence. This typically requires templates for the required IVDR elements, such as PEP, PER, SCP, APR, CPR, etc. Consequently, manufacturers need to understand what the IVDR requirements are and how they can be combined within the existing QMS. Depending on the company structure and level of transition to IVDR, updating the existing QMS might be a short task for some or significant work for others.  

Class D manufacturers who want to lodge an application in May 2025 must follow these procedures and create the relevant records. This will be reviewed for lodging the application with the Notified Body.

The chart below is a brief overview and comparison to corresponding EN ISO 13485 and other standards to further illustrate the complete QMS requirements:

^{EN ISO 14971:2019 + A11:2021 Medical devices - Application of risk management to medical devices}

^{ISO/TR 20416:2020(en) Medical devices — Post-market surveillance for manufacturers}

^{EN ISO 20916:2024 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice}

Pure Global can help you implement an EN ISO 13485 compliant QMS, conduct an audit, or update your QMS in preparation for the 26 May 2025 deadline, or to lodge an application or agreement with a Notified Body. Contact us to learn more about our QMS audit support services.