Does your laboratory's in-house IVD or LDT meet the conditions of Article 5(5) IVDR?
We help health institutions manufacture and use in-house IVDs, often called laboratory-developed tests (LDTs), under Art. 5(5) IVDR: the nine conditions, the justification against CE-marked tests, the public declaration and the documentation the competent authority can request. Once a test is transferred to another legal entity, the full IVDR applies to it.
Overview
When does a laboratory test stay in-house?
In-house IVDs in health institutions · IVDR Art. 2(29), 5(4) and (5), 6(2), 48(2), 113(3) · Annex I · MDCG 2023-1
Last updated: October 31, 2026
Art. 5(5) IVDR lifts most requirements of the regulation for devices manufactured and used only within a health institution established in the Union. The relevant general safety and performance requirements of Annex I continue to apply, and the exemption holds only while all nine conditions in points (a) to (i) are met.
- Manufacture and use stay within one legal entity. A test transferred to another legal entity loses the exemption (point (a)). MDCG 2023-1 notes that the concept of legal entity differs between Member States: several hospitals of one organiser can form one legal entity, and one hospital can house several. Results and patient specimens may still be shared.
- EN ISO 15189 and the quality management system are two separate conditions (points (b) and (c)). According to MDCG 2023-1, compliance with EN ISO 15189 does not cover the manufacturing process or Annex I and therefore does not on its own constitute an appropriate QMS for manufacturing in-house IVDs.
- The justification against devices on the market is the condition with the latest date. Under point (d) the institution documents why an equivalent device available on the market cannot meet the specific needs of the target patient group, or not at the appropriate level of performance. It applies from December 31, 2030 (Art. 113(3)(j)).
- For class D, the documentation is fixed by law. Point (g) requires documentation on the manufacturing facility, the manufacturing process, design and performance data and the intended purpose, detailed enough for the competent authority to check Annex I. Member States may extend this to classes A, B and C.
Services
How we support you
Art. 5(5) gap assessment
A check of each in-house test against points (a) to (i) and the relevant requirements of Annex I: does the organization meet the definition of a health institution (Art. 2(29)), do manufacture and use stay within one legal entity, and which conditions apply today and which from December 31, 2030. Deliverable: a list of in-house IVDs with status per condition and the open actions.
Quality management for in-house manufacture
Extending the laboratory QMS so that it covers the manufacture of in-house IVDs: risk management under Annex I Chapter I, design and performance data, manufacture and release, traceability, review of experience from clinical use and corrective actions (points (b), (h) and (i)). MDCG 2023-1 names Art. 10(8) IVDR as guidance on the minimum content.
Justification against CE-marked devices
A market review per test before the first manufacture, using EUDAMED, manufacturer information and other sources, and the documented reasoning why equivalent devices on the market do not meet the target patient group's needs (point (d), MDCG 2023-1 Section 3.6). Includes a process for repeating the review when new CE-marked tests become available.
How we work together
What it comes down to
An in-house IVD is a test that a health institution manufactures and uses itself, often called a laboratory-developed test. For the IVDR it is a device. MDCG 2023-1 gives examples: a PCR master mix assembled from ordered primers, buffer and enzymes, a CE-marked device modified into a new device, and diagnostic software developed and used on site.
Art. 5(5) lifts most obligations under conditions. The relevant requirements of Annex I continue to apply, and points (a) to (i) set out what the institution has to show instead of a conformity assessment: quality management, the laboratory standard, the justification against devices on the market, a public declaration, information for the competent authority and, for class D, documentation the authority can check against Annex I.
| Condition in Art. 5(5) | Content | Applies from |
|---|---|---|
| (a) | no transfer to another legal entity | May 26, 2022 |
| (b) | manufacture and use under an appropriate QMS | May 26, 2024 |
| (c) | laboratory compliant with EN ISO 15189 or national provisions | May 26, 2024 |
| (d) | justification against equivalent devices on the market | December 31, 2030 |
| (e) | information to the competent authority on request | May 26, 2024 |
| (f) | public declaration, including on Annex I | May 26, 2024 |
| (g) | documentation for class D, extendable by Member States | May 26, 2024 |
| (h) | manufacture in accordance with that documentation | May 26, 2024 |
| (i) | review of clinical experience and corrective actions | May 26, 2024 |
Class D covers, among others, tests that detect transmissible agents in blood, cells, tissues or organs to assess their suitability for transfusion, transplantation or cell administration (Annex VIII, Rule 1). For these tests the documentation under point (g) is mandatory; for classes A to C it depends on the Member State. The classification is therefore the first step of every assessment.
The line to the IVD manufacturer runs where the test leaves the legal entity. Supplied to another laboratory, it no longer falls under Art. 5(5); the full IVDR applies, including the conformity assessment under Art. 48 and CE marking. The same holds once production reaches an industrial scale, a term the IVDR leaves undefined.
The planned revision of the MDR and IVDR also concerns Art. 5(5); the state of the procedure is described in our article on the MDR/IVDR revision. Until it is adopted, the current text of Art. 5(5) applies. Outside the scope of this page are the classification itself and the IVDR project of a manufacturer.
Our approach
Our approach
Step
Result
Take inventory
A list of the in-house tests with intended purpose, class under Annex VIII and the CE-marked alternatives on the market.
Check the conditions
Status per test against points (a) to (i) and Annex I, separated into what applies today and what applies from December 31, 2030.
Build the documentation
QMS procedures for manufacture, the justification against market devices, the public declaration and, for class D, the documentation under point (g).
Keep it current
A review cycle for the market check, experience from clinical use and corrective actions, and documentation ready for requests from the competent authority.
Common pitfalls
Where projects commonly fail
The accreditation under EN ISO 15189 is taken as the quality management system.
Points (b) and (c) are separate conditions, and MDCG 2023-1 states that compliance with EN ISO 15189 alone is not an appropriate QMS for manufacturing in-house IVDs, because the manufacturing process and Annex I are outside the scope of the standard.
A test is passed to a partner laboratory belonging to another legal entity.
The exemption covers only devices that are not transferred to another legal entity (point (a)), so the partner would be using a device without CE marking. Sharing results and patient specimens between institutions is not affected (MDCG 2023-1 Section 3.1.3).
A CE-marked test is used by the institution for a different intended purpose.
Under MDCG 2023-1, where a health institution changes the intended purpose of a CE-marked device for use in the institution, Art. 5(5) applies; the same holds for a research use only product to which the institution ascribes a medical purpose.
The timeline in Annex B of MDCG 2023-1 is still used.
It shows May 26, 2028, for point (d), the date set by Regulation (EU) 2022/112. Since Regulation (EU) 2024/1860, point (d) applies from December 31, 2030 (Art. 113(3)(j)); the guidance of January 2023 has not been revised.
Product Development & Regulatory Strategy
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/746 (IVDR), consolidated version CELEX 02017R0746-20250110: Art. 2(29), Art. 5(4) and (5), Art. 6(2), Art. 10(8), Art. 48, Art. 113(2) and (3), Annex I, Annex VIII Section 2.1 (Rule 1)
- Regulation (EU) 2022/112 of January 25, 2022, amending the transitional provisions of the IVDR (marked M1 in the consolidated version)
- Regulation (EU) 2024/1860 of June 13, 2024, Art. 113(3)(j) IVDR (marked M4 in the consolidated version)
- MDCG 2023-1, Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (January 2023): https://health.ec.europa.eu/document/download/05b15d55-1bcf-4e17-99c4-15c706325847_en?filename=mdcg_2023-1_en.pdf
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Latest insights
All insights →Regulations & standards considered
- EU 2017/746 (IVDR), Art. 2(29) (health institution)
- EU 2017/746 (IVDR), Art. 5(4) and (5) (devices manufactured and used within health institutions)
- EU 2017/746 (IVDR), Art. 6(2) (diagnostic services offered at a distance)
- EU 2017/746 (IVDR), Art. 48(2) (conformity assessment before putting into service, exception for in-house devices)
- EU 2017/746 (IVDR), Art. 113(2) and (3)(i) and (j) (dates of application of Art. 5(5))
- EU 2017/746 (IVDR), Annex I (general safety and performance requirements) and Annex VIII (classification rules)
- EU 2022/112 and EU 2024/1860 (amendments to the dates of application)
- EN ISO 15189 (medical laboratories, cited in Art. 5(5)(c) without a date)
- MDCG 2023-1 (health institution exemption under Article 5(5), January 2023)
Related topics
IVD Consulting & IVDR Readiness →
IVDR implementation for manufacturers, the route for a test that leaves the institution
Qualification & Classification →
Classification under Annex VIII, which decides whether the class D documentation applies
Risk Management →
The risk management system that Annex I Chapter I also requires for in-house IVDs
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