<img alt="" src="https://secure.52enterprisingdetails.com/787780.png" style="display:none;">
Skip to content
    en

    IVDR compliance for in-house developed tests

    The new In Vitro Diagnostic Medical Device Regulation (IVDR) has been applied in phases starting on 26 May 2022. The IVDR and the national law of each EU Member State also concerns in vitro diagnostics (IVDs) developed in-house by clinical laboratories. Such in-house developed tests include IVDs manufactured by the laboratory as well as CE marked IVDs that are modified by the laboratory.

    Contact us

    About IVDR compliance

    When a laboratory develops IVDs in-house (also called Laboratory Developed Tests, LDT's), they must maintain Technical Documentation and update their Quality Management System to comply with the IVDR and the national law, including the requirements for manufacturing. If an equivalent CE marked device is available on the market or the scale of manufacturing of the IVD is industrial, the laboratory cannot use this option provided in the IVDR (Article 5.5), but must CE mark the IVD.

    Our strong experience in IVD test kits, instruments and medical device software ensures that we can support you in getting your Quality Management System and Technical Documentation compliant with IVDR. Our expertise also covers single-use IVDs, companion diagnostics (CDx), and genetic tests.

    Aurevia

    How can we help?

    We offer the following services to clinical laboratories:
    • Regulatory expert support for the planning and creation of the necessary processes and documentation.
    • QMS and technical documentation updates
    • Support in CE marking activities
    • Training and workshops on the effects of the IVDR on in-house developed tests.
    • The digital Entries tool for defining the applicable requirements of the IVDR for the laboratory professionals in a matter of minutes.
    doctor-performing-medical-research-lab (2)

    Contact us for more information

    Leave a contact request

    Explore our services

    young-man-using-laptop-desk-office

    Regulatory plans

     Our experienced professionals help medical device manufacturers develop regulatory plans that support their entire product lifecycle.

    Read more
    female-entrepreneur-talking-colleague

    Technical documentation

    All medical devices must have documentation available to support its compliance to applicable regulations. Aurevia supports you in planning and developing your technical documentation.

    Read more
    labquality_com_24

    Electrical Safety IEC 60601

    IEC 60601-1 is the basic international safety standard for medical electrical devices and systems.

    Read more
    labquality_com_27

    Biological Safety ISO 10993

    The international standard for the biological safety evaluation process and preparing biological evaluation documentation for medical device manufacturers.

    Read more
    labquality_com_31

    IVDR compliance for in-house developed tests

    Laboratories developing IVDs in-house must maintain technical documentation and Quality Management Systems to comply with the IVDR and national law.

    Read more
    labquality_com_19

    IVD performance evaluation

    In vitro diagnostic medical device (IVD) regulations are set in the EU In Vitro Diagnostics Regulation (IVDR).

    Read more
    labquality_com_29

    Qualification and classification of medical devices

    Our team’s versatile experience and the available tools help in bringing clarity to the most challenging cases.

    Read more
    labquality_com_8

    Medical software

    Let our experts help you understand and adhere to medical device software regulations throughout the entire lifecycle.

    Read more
    labquality_com_25

    Risk management ISO 14971

    We can help you setup and implement a risk management system and prepare risk management documentation.

    Read more

    Latest news

    Read the latest news from the world of quality.

    Notice about a change in some of our email addresses

    As part of the upcoming company split on 1 January 2026, some of our email domains will change to @labquality.com...
    Read more

    How do you shape regulatory complexity into strategic clarity?

    As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the...
    Read more

    Fast track for mononational clinical trial applications in Sweden

    Starting September 1, 2025, the Swedish Medical Products Agency (Läkemedelsverket) introduced a fast-track process for...
    Read more

    Upcoming webinar: what IVDR Article 5(5) means for your lab

    Whether your lab is already working under IVDR and Article 5(5), evaluating tests, or preparing for transition, this...
    Read more

    IVDR reality check: are we moving fast enough?

    As of February 2025, approximately 1,500 IVDR certificates have been issued. That’s progress — but is it enough? With...
    Read more