The short answer: No, typically not
We are often asked if it is enough for a lab to be ISO 15189 accredited to fulfill IVDR quality requirements.
The short answer here is: No, it is not enough now that lab-developed tests are being regulated under IVDR.
Take a deep breath and we’ll explain.
Two main IVDR quality requirements
IVDR Article 5 (5)—which outlines the requirements for health institutions offering in-house tests—has two clauses related to quality standards.
First, it mandates that “the manufacture and use of [in-house] devices occur under an appropriate quality management system.”
Second, it mandates that clinical labs must be “compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation.”
At first glance it may seem that these two requirements are really only one, namely that labs should at minimum be compliant with ISO 15189—which specifies the quality and competence requirements for medical laboratories—and also meet any national requirements regarding quality.
But the implications of these two clauses are more complex when you look closer.
ISO 15189 and national mandates
It is easier to start explaining with the more straight-forward second requirement regarding ISO 15189. The IVDR maps out requirements for all EU member nations, in this case mandating ISO 15189 compliance. That is, all EU labs must be able to demonstrate compliance with the standard in an audit.
But each country may have national requirements that substitute or go beyond what IVDR mandates regarding lab quality. France, Ireland and Hungary require all diagnostic labs to be accredited rather than simply “compliant” with ISO 15189. Others require this only for labs that perform certain types of tests, for example Belgium for oncology and virology, or Germany for newborn screening.
Accreditation involves visits by the national accreditation body at defined intervals to assess compliance and update the accreditation status.
Accreditation or not?
The MDCG has reconfirmed that accreditation is not per se necessary: “Compliance with the standard EN ISO 15189 may be understood as accreditation to the standard or other means of compliance.” (MDCG 2023-1)
So if the IVDR itself does not actually require it, why should labs pursue it?
First of all, as above, some must due to national mandates.
Yet even without this, your lab should consider it. If you must carefully document compliance with this standard anyway, it is likely worth going the extra step with an accreditation body to ensure compliance and have convenient proof for auditors. Not to mention that accreditation inspires trust in a lab.
What is an “appropriate” QMS?
But even if a lab is bona fide ISO 15189 accredited, this does not necessarily mean that they have met the first requirement regarding an “appropriate” quality management system for lab-developed tests. This is because ISO 15189 does not have provisions for the design, development and manufacture of in-house devices.
The QMS needs to cover all processes related to Article 5.5 lab requirements. It must be expanded depending on the specific activities carried out by the laboratory in connection with an in-house test.
For activities such as test design, development and manufacture, processes must be established which can be taken, for example, from ISO 13485, the quality standard for medical device manufacturers.
If software is developed in-house, such as a bioinformatics pipeline, then the process specifications of IEC 62304 are also highly recommended.
Labs will therefore need to include some provisions from other standards. There is, however, no need to follow the entire standard. The trick is in knowing which parts to follow.
What is an “appropriate” QMS?
Each lab must ensure they follow the applicable national requirements. And since many countries are currently reconsidering requirements in light of IVDR, you will need to make sure your lab is up-to-date on coming changes. Consider checking with your national competent authority for the latest information.
To find out more about the various national authorities:
