QM for IVD: The basis of product quality and regulatory compliance
The quality of in vitro diagnostic medical devices (IVD) has a direct impact on the safety of patients, users and third parties. Therefore, quality management systems (QMS) are required and regulated for IVDs worldwide.In vitro diagnostic medical devices are regulated in the European Union by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) which in Article 10(8) explicitly requires manufacturers to have a quality management system in place. Distributors and importers must also establish a QMS for certain activities in accordance with Article 16(3).Article 8 of the IVDR stipulates that products that comply with harmonized standards are presumed to be in conformity with the requirements of this Regulation. EN ISO 13485:2016/A11:2021 is currently the only standard that is harmonized with the IVDR with regard to the establishment of a QMS. The above-mentioned economic operators can therefore demonstrate through a EN ISO 13485 certification that their QMS meets the IVDR requirements. The harmonization table in Annex ZB should be taken into account. Among other things, it highlights the topics that are not covered by the standard and must be integrated into the QMS in addition to the processes described in the main part of the standard. These include processes such as traceability (UDI), post-market surveillance (PMS), post-market performance follow-up (PMPF), and vigilance.When the IVDR came into force, more precise regulatory requirements were also established for self-developed laboratory tests (LDT), known as in-house IVDs. These are tests that are produced and used in a healthcare facility within a suitable QMS. The IVDR requires laboratories at these healthcare facilities to comply with the EN ISO 15189 standard or, where applicable, national (accreditation) regulations. In addition to the aforementioned standard, healthcare facilities must meet the essential safety and performance requirements as specified in Annex I of the IVDR. Processes for implementing these requirements must be integrated into the QMS.Companies that currently market their products on the US market will have to convert their QMS on February 2, 2026, as US legislation will be aligned with ISO 13485:2016. Since ISO 13485:2016 refers to a quality management system, the previous designation of 21 CFR Part 820 as "Quality Systems Regulation (QSR)" has been replaced by "Quality Management System Regulation (QMSR)". As with the IVDR, economic operators must comply with additional legal requirements that are not covered by the standard.
In general, the quality management system must be appropriate for your organization, your products and/or services, and your target markets.
Other QM systems
Appropriate standards are advantageous for the introduction of a quality management system (QMS) as they contain specifications for structured processes and use clearly defined terms. The most relevant QMS standards are ISO 9001:2015 and ISO 13485:2016. The latter is harmonized with the requirements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in the version EN ISO 13485:2016/A11:2021. For medical laboratories, ISO 15189:2022 contains specifications for a suitable QMS. In contrast to the other two standards, the laboratory standard is not a certifiable standard, but an accreditation standard.Even though the standards differ in part in terms of content, the basic processes are identical. For this reason, it is possible to switch from one standard to another without any major problems. It is also possible to comply with several standards at the same time by implementing an integrated quality management system.Our experts will be happy to answer your questions on this topic
Our services for your QMS for IVD
Would you like to introduce a QMS but are unsure which standard is most suitable for you? Do you need support in establishing suitable QMS processes? We would be happy to help you decide on a standard and implement it.Are you ISO 9001 certified and would like to know what steps are necessary for ISO 13485 certification? Is your QMS up to date? We would be happy to perform a GAP analysis and, of course, we can also assist you in closing any identified gaps if you wish. We can help you set up and maintain your individual quality management system (QMS) so that you can quickly and reliably achieve regulatory compliance and obtain the necessary certifications, including those relating to your products.
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We support you to the best of our ability and competently with your quality management for Europe, USA and other countries.QM internationalTogether we establish proof that your documentation and QMS comply with all requirements.AuditsWe also offer individual and suitable solutions for laboratories to ensure that your QMS meets the requirements.Laboratories