The EU regulates medical laboratories – Are Laboratory Developed Tests still allowed?

This article will help you ensure that you will still be able to offer in-house IVD (also called Laboratory Developed Tests, LDTs) under the IVDR and will explain the three options open to you avoiding legal disputes.

In-house IVD are a type of in vitro diagnostic test. But do regulatory requirements such as the IVDR also apply to these kind of products? This article provides an overview not just for medical laboratories.

1. Why you might have to reduce the range of tests you offer

The EU legislator is regulating Laboratory Developed Tests for the first time with EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). As a result, its requirements apply directly to laboratories that offer tests they developed themselves.

While most of these requirements already existed, the additional provisions restrict the use of certain in-house IVDs by medical laboratories. For example, this restriction applies when a comparable CE-IVD device is available on the EU market.

This article explains what this means for you and how you can avoid this problem. First, however, it outlines the basic principles.

2. In-house IVD: What are they?

a) Definition of terms

The IVDR does not define in-house IVD or LDT under the definitions in Article 2 but provides the following description in Article 5:

The guidance document MDCG 2023-1 of the Medical Device Coordination Group designates corresponding tests as “in-house devices”:

The US FDA defines the term “Laboratory Developed Tests” as follows:

b) Differentiation from medical devices manufactured in-house

It is important to differentiate LDTs, or “in vitro diagnostic medical devices from in-house production,” from “medical devices from in-house production”. In the case of a “medical device from in-house production,” we would talk about in-house production according to Article 5(5) MDR.

c) Use of in-house IVDs

Medical laboratories examine specimens derived from the human body: Tissue and body fluids (e.g., blood, urine, cerebrospinal fluid, etc.). To make diagnoses or to obtain information relevant for the diagnosis, laboratories use:

1. commercial in vitro diagnostic (IVD) medical devices, or
2. non-CE-marked, modified, or self-developed tests, known as LDTs

Whenever laboratories use CE-IVD devices, they may alternatively use in-house IVDs. The IVDR, however, restricts in-house IVD use to health institutions, which it defines as follows:

Medical laboratories deliver medical information to patients or their treating physicians to support diagnosis. Accordingly, medical laboratories qualify as health institutions under the definition.

Each IVD test in a medical laboratory begins with the collection of a specimen from the patient. Ideally, it ends with a result that is helpful for deciding on further treatment. Figure 1 shows the usual steps in an IVD test process from the taking of the specimen through to the results. CE-IVD devices or in-house IVD devices can be used for all these steps.

d) Criteria that make a test an LDT

An LDT is not usually a self-developed product but rather a procedure that uses self-developed devices in the test sub-steps. However, patients and their treating physicians generally do not know whether a laboratory performs a test using an in-house IVD or a CE-IVD device. (see Fig. 3).

For this reason, a medical laboratory creates an in-house IVD when it:

• uses products or procedures it has developed itself,
• uses non-IVD devices in diagnostic procedures (e.g., for Research Use Only, RUO),
• combines products or processes that are not intended for the combination, or
• uses a CE-IVD device outside its intended purpose, e.g., when they:
  • misuse the device (off-label use) or
  • modify commercial devices (including if they deviate from the instructions for use of conventional IVD devices).

If one or more of these criteria apply to your tests, the requirements in the next section apply in full to your medical laboratory.

3. Legal requirements

a) Previous requirements for in-house IVD in Germany

Putting in-house IVD into service was only permitted according to section 12 of the MPG if the general requirements of EU Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD) have been met. This means that if you have already offered an in-house IVD in Germany before May 26, 2022, you must comply with Annex I of the IVDD.

Medical laboratories also have to comply with the “Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen” the Rili-BÄK for short. This is established in the Medizinprodukte-Betreiberverordnung (MPBetreibV) and has not changed since the IVDR came into force.

b) Requirements of the IVDR for in-house IVDs:

The IVDR wants to continue to permit in-house devices without the involvement of notified bodies and without CE marking. As a result, in Article 5(5), the IVDR sets out the requirements that laboratories must meet for tests manufactured and used only within health institutions (including remote use of in-house IVD software; see MDCG 2023-1 3.2.2). These are as follows:

1. Demonstrate compliance with the general safety and performance requirements according to Annex I of the IVDR. These include, among other things:
   • Documentation of intended purpose
   • Implementation of a risk management system
   • Performance evaluation
   • Compliance with the software life cycle
   • Ensuring IT security
   • Safe product design
   • Provision of product information
2. The manufactur and use of in-house IVDs within the framework of appropriate quality management systems.
   • ISO 15189 does not specify any requirements for the development and manufacture of IVD devices. To meet this requirement, laboratories can, for example, apply the requirements set out in Chapter 7 of ISO 13485.
3. Documented justification that the target patient group’s specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market.
   • This is certainly a decisive new requirement, because it means that many in-house IVDs for which there is an equivalent CE-IVD product on the market no longer have a right to exist.
4. A publicly available declaration identifying the in-house products and confirming compliance with Annex I of the IVDR.
5. Monitoring of products.
6. Prohibition of distribution.
7. Prohibition of industrial-scale production.

The Johner Institute supports medical laboratories in the implementation of all IVDR requirements. Contact us if you have any questions.

c) Summary of the legal requirements

Almost all requirements found in the IVDR already existed in the same or a similar way within the framework of the MPG and the associated ordinances.

Although the new Annex I of the IVDR is longer than Annex I of the IVDD, the key elements still include:

• risk management
• a safe and powerful device design
• usability
• performance evaluation
• software life cycle processes

IT security is a major new requirement.

Currently, there are no exemptions from surveillance for certain in-house IVDs (e.g., for the diagnosis of rare diseases) planned, as implemented by the FDA.

4. Transitional periods

In January 2022, the IVDR introduced new transitional periods, which also addresses the requirements of Article 5 (5) and thus affect in-house IVDs. In June 2024, authorities further adjusted the transitional period for Article 5(5)(d).

5. IVDR revision

On December 16, 2025, the EU Commission published a proposal to revise the IVDR. This proposal also includes changes to Article 5 (5). The greatest relief would come from the elimination of IVDR Article 5 (5) d). This would allow laboratories to operate in-house IVDs even if equivalent CE-IVDs are available on the market. In addition, the regulation would strengthen ISO 15189 accreditation, permit the transfer of in-house products in specific cases, and more clearly regulate their use in clinical trials.

6. Surveillance by authorities

In Germany, the respective state authorities are responsible for the surveillance of the laboratories for compliance with the IVDR. They also check whether laboratories are complying with the MPBetreibV and thus explicitly ensure compliance with the Rili-BÄK. If your laboratory is accredited according to ISO 15189, DAkkS monitors the implementation of the standard.

IVDR Article 5(5), subparagraph 2, explicitly mentions the rights of member states in the monitoring of health institutions.

Chapter 3.7 of MDCG 2023-1 specifies the information that monitoring authorities may request.

7. Conclusion

a) The IVDR makes concrete demands on laboratories

Although the MPG already required the general requirements of Annex I of the IVDD to be met, comprehensive compliance with these requirements was not achieved.

The IVDR now establishes uniform requirements for laboratories across Europe.

• Laboratories must develop, manufacture and surveil their own Laboratory Developed Tests (largely) in conformity with the requirements of the IVDR.
• The use of commercially available IVD devices is preferred and laboratories can only offer their own LDTs if the devices on the market do not meet the required performance.

The previous system was also difficult to understand: Why should the regulatory requirements for a laboratory test depend on whether it was developed by a laboratory or an IVD manufacturer?

A lot of medical laboratories are not fully aware of the existing and the new requirements. It’s high time they got busy. Tougher competition between laboratories and legal disputes with IVD manufacturers should be expected.

b) Your next steps as a medical laboratory

1. Prioritize the fulfillment of the requirements from Annex I and implement them NOW, if you have not already done so.
2. Expand your quality management system to include the required points and generate the resulting documentation by May 2024.
3. Comply with the additional requirements of Article 5 (5) of the IVDR.
4. Investigate the market and look for devices whose performance promises for the same patient target group corresponds to your in-house IVD.

There is no such device on the market? Congratulations, then you can offer your in-house IVD beyond 2028!

However, if there is an equivalent device on the market with the same level of performance, you should consider a strategy. The Johner Institute will be happy to support you.

Make a decision:

1. No longer offer the test.
2. Purchase and use the authorized competitor test.
3. Place your own test on the market as a CE-IVD device.

If you decide to place the test on the market as a CE-IVD device:

1. Establish a QMS according to ISO 13485.
2. Find a notified body.
3. Comply with the extended requirements of the IVDR (depending on the risk class of the device), create device-specific technical documentation, and declare conformity.

---

Change history

• 2026-03-12:
  • New Chapter 5 on the IVDR revision
  • Update of Chapter 3 b)
• 2025-07-30:
  • Removal of the entire previous section 3 c) due to the withdrawal of the FDA LDT Final Rule
• 2024-06-04:
  • Revision of chapter 3 c) on the FDA’s new rules on LDTs
  • Adaptation of chapter 4 to new transitional periods
• 2023-01-12:
  • Adaptation of the definition “In-house device” according to the new MDCG 2023-1Reference to MDCG 2023-1 and slight adjustments in chapter 3. b)
• 2022-12-09: Notes on the revision of ISO 15189 added
• 2022-06-08:
  • Conversions due to the IVDR which has become valid”LDT” replaced by “In-house IVD”, the official wording of the EUAdjustments due to the transition periods
  • Removal of chapter 3 e) “Effects of the ongoing coronavirus pandemic”
• 2021-04-22: Chapter 3. e) on the effects of the ongoing coronavirus pandemic inserted and editorial changes
• 2021-12-01: Corrections, adjustments to links and editorial changes throughout the article. Adaptation of the chapters
  • a): Revision of the definitionsb): Restructured4: New section on transition periods added
  • b): Adaptation to possible new transition periods