Quality Management of In Vitro Diagnostics (IVD) in Laboratories

Medical laboratories bear a special responsibility. For example, employees can be harmed in the event of user errors during routine activities. Patients can also be harmed (indirectly) if incorrect test results lead to a misdiagnosis or an inappropriate treatment strategy. For this reason, laboratories in Germany are legally required to establish a quality management system (QMS).

Quality requirements for in-house IVD

The terms in-house IVD or laboratory developed tests (LDT) refer to products that are manufactured within a healthcare facility and used exclusively there. "In-house" IVDs are typically used when there is no suitable CE-marked IVD on the market for a required test procedure.

Please note: This term covers not only tests developed entirely by a laboratory itself, but also other products if
  1. CE-marked IVDs are used and the laboratory deviates from the manufacturer's specifications, e.g., with regard to sample preparation, sample or reagent dilution, sample type, patient group, etc.
  2. research products (research use only, RUO) without CE marking are used by the laboratory for the examination of a sample.
  3. the laboratory combines CE-marked IVDs with other products (including other IVDs) in a manner not intended by the manufacturer.

Since the entry into force of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), healthcare facilities must meet additional legal requirements if their laboratories manufacture and use in-house IVDs (Article 5 (5)). The IVDR explicitly requires these laboratories to apply the EN ISO 15189 standard and to obtain corresponding accreditation, but also to meet the essential safety and performance requirements that apply to all in vitro diagnostic medical devices. These requirements are not covered by the afore-mentioned standard, so additional processes must be implemented in the existing QMS.

Do you have any questions? Please do not hesitate to contact us! Our initial consultations are non-binding and free of charge.

The most efficient way to meet the requirements for in-house IVD is to integrate the relevant processes of EN ISO 13485 into the existing EN ISO 15189 quality management system.

Our initial consultations are non-binding and free of charge. Any questions? Contact us!

Find out now what you need to know about quality management systems for in-house IVD

What testing laboratories and medical laboratories should consider with regard to their QMS

Medical laboratories in Germany must meet the requirements of the German Medical Association's guidelines on quality assurance for laboratory medical examinations (Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen (RiliBäk). Accreditation is not required across the board for medical laboratories and is initially voluntary. It offers the advantage of an objective evaluation by a national accreditation body, such as DAkkS. Accreditation proves that laboratories have the necessary expertise and deliver accurate and reliable results. This promotes confidence in the results of laboratory tests and may offer a competitive advantage.
In certain cases, accreditation is de facto mandatory either according to EN ISO 15189:2022 or EN ISO/IEC 17025:201. If the laboratory performs special diagnostic, forensic, or toxicological tests, for example, accreditation may be mandatory as proof of compliance with quality requirements. Accreditation confirms that the laboratory meets all requirements to perform a specific conformity assessment activity (see also REGULATION (EG) Nr. 765/2008).

For medical laboratories, accreditation according to ISO 15189:2022 is also mandatory if they manufacture and use in-house IVDs. In this case, in addition to the requirement to comply with the RiliBAÄK and the accreditation standard, there is also a need to observe the QMS requirements of the IVDR. The most efficient way to do this is to establish an integrated QMS in which the relevant points of the IVDR-harmonized standard EN ISO 13485:2016 + AC:2018 + A11:2021, in particular Chapter 7, are incorporated into the existing laboratory-specific QMS.
In addition to the requirements for a QMS, the accreditation standard EN ISO 15189:2022 also contains specifications for risk management. For medical laboratories, this means that they must also deal with EN ISO 22367:2020, which describes the application of risk management to medical laboratories.

While EN ISO 15189:2022 is specific to medical laboratories, testing and calibration laboratories apply EN ISO/IEC 17025:2017. This standard also specifies general requirements for the competence, impartiality, and consistent operation of laboratories. In contrast to the EN ISO 9001:2015 certification standard, the EN ISO/IEC 17025:2017 accreditation standard contains additional requirements for the technical competence of laboratories.

Whether ISO 13485, ISO 9001, ISO 15189 or ISO 17025: You have questions? We have answers!

Also check out our blog on QM.

Our quality management services for in-house IVDs:

  • Are you a manufacturer of in-house IVDs and wondering which standards you should consider for establishing your QM system?
    We will be happy to advise you in detail and develop a meaningful quality management system together with you.
  • You already have a QMS and could use support in revising/updating it?
    Let's discuss it.
  • From GAP analysis to the development of processes, standard operating procedures and work instructions -
    We actively support you and find individual solutions to suit your needs.