In-House Devices under Article 5(5) IVDR and MDR: The Conditions for Health Institutions and Laboratory Tests

A device that meets every condition of its regulation needs only the relevant Annex I requirements, while the two lists of conditions differ in content, in dates and in the documentation they demand.

The exemption concerns hospitals and institutions such as laboratories and public health institutes that make their own devices or tests, from a modified CE-marked device to an assay built from research-use-only reagents. This page compares the conditions of the two regulations, explains the industrial-scale exclusion, the laboratory standard, the justification against equivalent devices, the public declaration and the documentation, and sets out when each IVDR condition applies. It then summarises what MDCG 2023-1 explains, the national rules of five member states and what the pending revision COM(2025) 1023 would change.

What Is an In-House Device?

An in-house device is a device that is manufactured and used only within a health institution established in the Union and that meets all conditions set in Article 5(5) of the MDR or the IVDR, as MDCG 2023-1 defines the term in its Section 2. Both elements must be present: the place (one health institution in the Union) and the conditions (Article 5(5) of the regulation that covers the device).

The two acts are Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Both have been in force since 25 May 2017 (MDR Article 123(1), IVDR Article 113(1)) and are regulations, directly applicable in every member state without transposition. Only the relevant general safety and performance requirements of Annex I apply to in-house devices that meet Article 5(5). How the exemption fits the EU MDR and IVDR as a whole is set out on the home page.

Which Organisations Count as a Health Institution

MDR Article 2(36) and IVDR Article 2(29) define a health institution as "an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health". The two definitions use the same words, so one organisation is a health institution under both regulations or under neither.

MDR recital 30 and IVDR recital 29 name the organisations on each side of the line. Hospitals count, and so do institutions such as laboratories and public health institutes that support the health care system or address patient needs without treating patients directly. A central laboratory that never sees a patient can therefore still be a health institution. Establishments that primarily claim to pursue health interests or healthy lifestyles do not count, and the recitals name gyms, spas, wellness centres and fitness centres as examples. A wellness centre that makes a device for its clients cannot rely on Article 5(5), whatever the device is.

What Manufacturing and Using a Device Only Within the Institution Covers

MDCG 2023-1 explains in Section 3.2.1 that manufacture covers more than building a device from raw materials: combining components into a new device, modifying a device, changing the intended purpose of a CE-marked device and giving a research-use-only (RUO) product a medical purpose all count. A laboratory that gives an RUO product a medical purpose therefore manufactures a device in this sense.

The same institution must both make and use the device. Custom-made devices fall outside Article 5(5) (MDCG 2023-1 Section 3.1), so a device made to a written prescription follows its own route, described in the border section below. The general placing-on-the-market rules sit in Article 5 of the EU MDR (Regulation (EU) 2017/745).

The Article 5(5) Conditions in Both Regulations

MDR Article 5(5) sets eight conditions, points (a) to (h), and IVDR Article 5(5) sets nine conditions, points (a) to (i), and a device is an in-house device only if the health institution meets every condition of the regulation that applies to it. The two lists differ in number and in content, so an institution that makes both medical devices and IVDs checks each device against its own regulation.

In both regulations, the last subparagraph of Article 5(5) excludes devices manufactured on an industrial scale. The table below compares the subjects that the two lists treat, with the point that sets each of them and the date from which the IVDR point applies.

MDR Article 5(5) has eight conditions and IVDR Article 5(5) nine; only the subjects above are compared.

The IVDR conditions apply in phases, set out in the dates section below, while MDR Article 5(5) has applied in full since 26 May 2021. The in vitro diagnostic regime as a whole is explained under the IVDR (Regulation (EU) 2017/746).

Meeting the Conditions in Practice

Six points decide in practice whether a health institution can rely on MDR or IVDR Article 5(5): the scale of manufacture, the quality system and the laboratory standard, the justification against equivalent devices, the public declaration, the documentation and the powers of member states. Each point has its own legal basis, and the IVDR points do not all apply from the same date.

Industrial-Scale Manufacture Is Excluded

The last subparagraph of MDR Article 5(5) and of IVDR Article 5(5) states that the paragraph "shall not apply to devices that are manufactured on an industrial scale". The exclusion takes the device out of the exemption altogether, so a device made on an industrial scale must meet the regulation in full even when the institution uses it only internally. MDCG 2023-1 Section 3.11 explains that the term industrial scale is not defined in either regulation and is not synonymous with mass-produced. For IVDs, the guidance adds that a large number of specimens tested does not by itself mean industrial scale, so a high-throughput hospital laboratory is not excluded for its volume alone. Under the IVDR, the exclusion has applied since 26 May 2022.

Quality Management and the Laboratory Standard

IVDR Article 5(5)(c) requires the laboratory to comply with EN ISO 15189 or, where applicable, with national provisions, including national provisions on accreditation. The condition has applied since 26 May 2024 and names EN ISO 15189 as the reference point for the laboratory that makes the in-house IVD.

MDCG 2023-1 Section 3.5 explains that compliance with EN ISO 15189 alone does not constitute an appropriate quality management system for manufacturing in-house IVDs. A laboratory accredited to the standard therefore still needs a system that covers the manufacture of its own tests. MDCG 2021-5 rev.1 adds that the reference in point (c) is a condition of the exemption, not a presumption of conformity. The edition and status of the standard are covered under ISO 15189 under the EU MDR and IVDR.

Justifying That No Equivalent Device Meets the Need

IVDR Article 5(5)(d) requires the health institution to justify in its documentation 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. The justification therefore covers two questions: whether an equivalent device is available on the market, and whether it reaches the appropriate level of performance for that patient group.

Point (d) applies from 31 December 2030 under IVDR Article 113(3)(j) as amended by Regulation (EU) 2024/1860. The earlier date of 26 May 2028, set by Regulation (EU) 2022/112, is superseded and no longer applies. An IVDR in-house device therefore needs no such justification until 31 December 2030, although the other IVDR conditions already apply.

The Public Declaration

The health institution draws up a declaration, which it makes publicly available, giving its name and address, the details needed to identify the devices and a declaration that the devices meet the general safety and performance requirements, with a reasoned justification for any requirement not fully met (MDR Article 5(5)(e), IVDR Article 5(5)(f)). Under the IVDR, point (f) has applied since 26 May 2024.

MDCG 2023-1 Annex A offers a template with six columns: identification of the device, type (IVD or medical device), risk class, intended purpose, whether the requirements are fully met (yes or no) and the justification. One template therefore serves an institution that makes devices under both regulations. The requirements themselves are those of Annex I, explained under the general safety and performance requirements.

Documentation by Regulation and Class

Under the MDR, the documentation duty of Article 5(5)(f) applies to every in-house device regardless of class. A class I instrument made in a hospital workshop needs documentation just as a class III device does.

Under the IVDR, Article 5(5)(g) requires documentation on the manufacturing facility, the manufacturing process, the design and the performance data for class D devices. Member states may extend this duty to in-house IVDs of classes A, B and C, so the national rules below decide whether a laboratory documents its lower-class tests in the same way.

What Member States May Require

Under the second subparagraph of MDR Article 5(5), member states may require health institutions to submit further information, retain the right to restrict the manufacture and use of any specific type of such devices, and are permitted access to inspect. The national rules on in-house devices of five member states are summarised in the national rules section below.

When Each IVDR Condition Applies

IVDR Article 5(5) applies in three steps: the chapeau, point (a) and the industrial-scale exclusion since 26 May 2022, points (b), (c) and (e) to (i) since 26 May 2024, and point (d) from 31 December 2030; MDR Article 5(5) has applied in full since 26 May 2021. The three IVDR steps are shown in the table below with the instrument behind each date.

MDR Article 5(5) has applied in full since 26 May 2021 (MDR Article 123(2)). Status as of 6 November 2026.

The 2024 step comes from IVDR Article 113(3)(i), inserted by Regulation (EU) 2022/112, adopted on 25 January 2022 and published in OJ L 19, 28.1.2022, p. 3, in force since 28 January 2022. The 2030 date comes from IVDR Article 113(3)(j) as amended by Regulation (EU) 2024/1860, published in OJ L, 2024/1860, 9.7.2024, and in force since 9 July 2024. The dates for CE-marked legacy IVDs are a separate matter, set out under IVDR transition periods.

As of 6 November 2026, every IVDR in-house condition except point (d) applies.

What MDCG 2023-1 Explains

MDCG 2023-1, "Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746", is the Medical Device Coordination Group's guidance of January 2023 and the version on the Commission's list under the topic "In-house devices" as of 6 November 2026. The guidance is not legally binding; the MDCG works under MDR Articles 103 and 105 and IVDR Articles 98 and 99. The parts of the guidance used on this page are listed below.

• Section 2: the definition of an in-house device.
• Section 3.1: custom-made devices out of scope of Article 5(5).
• Section 3.2.1: what manufacture includes, such as RUO products given a medical purpose.
• Section 3.5: EN ISO 15189 alone is not an appropriate quality management system.
• Section 3.11: industrial scale, not defined and not synonymous with mass-produced.
• Annex A: the public declaration template.
• Annex B: a date for IVDR point (d), now superseded.

Annex B has not been updated for Regulation (EU) 2024/1860 and still gives 26 May 2028 for IVDR point (d); the law now says 31 December 2030. A laboratory that plans from Annex B alone therefore works with a superseded date. Every other document of the group is listed under MDCG guidance.

National Rules on In-House Devices

The MDR and the IVDR leave room for national rules on in-house devices, and the national laws of Germany, Romania, Slovenia, Spain and Sweden contain provisions on them, as of 6 November 2026. The table below lists the instrument of each of the five states and what it adds to Article 5(5).

Slovenia uses the IVDR option to extend the documentation duty: ZMedPri-1 Article 13 requires documentation for in-house IVDs of classes B and C as well as class D. Germany has the same option in the form of an empowerment of the ministry under § 88(1) Nr. 10 MPDG. The table covers these five states only; the other member states are covered on their own country pages.

The Pending Revision and Article 5(5)

Commission proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)) would change the in-house rules, but as of 6 November 2026 it is pending, at the stage "Awaiting committee decision" in the European Parliament with SANT as lead committee, and it is not law.

The past procedural events in the European Parliament, as of 6 November 2026, include the announcement of the committee referral on 25 March 2026 and the draft report PE787.987 of 30 June 2026. Every amending act and the proposal are tracked under MDR and IVDR amendments.

The changes the proposal would make to the in-house rules are listed below.

• Transfer: an in-house device could go to another health institution in the duly justified interest of public health, patient safety or patient health, or to prepare for or respond to a public health emergency.
• Equivalent device: IVDR condition (d) would be deleted.
• Continued use: under the MDR, an institution could continue to manufacture and use an in-house device for a maximum of 10 years once an equivalent device is available.
• Clinical trials: IVDR Article 5(5) would apply to laboratories established in the Union that provide testing for clinical trials under Regulation (EU) No 536/2014.
• Accreditation: accredited laboratories would have lighter public declaration and class D documentation duties under the IVDR.

In-House Devices Compared with Other Routes

An in-house device is manufactured and used only within one health institution and meets only the relevant Annex I requirements; every other device falls under the full MDR or IVDR. The three comparisons below cover the US term LDT, devices made to a prescription and the rule before the IVDR.

Laboratory-Developed Tests in EU Terms

Laboratory-developed test (LDT) is a US term; in EU law the matching concept is the in-house device under IVDR Article 5(5), and the EU texts use the word "in-house" instead. In an EU context, the question "LDT vs IVD" is therefore a question about the difference between an in-house IVD and every other IVD.

That difference is one of route. An in-house IVD is made and used only within one health institution and meets the conditions of IVDR Article 5(5) with the relevant Annex I requirements. Every other IVD falls under the full IVDR, including classification, conformity assessment and CE marking.

Devices Made to a Written Prescription

Custom-made devices are a separate MDR category and are out of scope of Article 5(5) (MDCG 2023-1 Section 3.1). A hospital that makes a device to a written prescription follows a different route, and the Annex XIII route is explained under custom-made devices under the MDR.

The IVDR has no custom-made category, so the question arises only for medical devices.

In-House Tests before the IVDR

The IVD Directive 98/79/EC did not apply to devices manufactured and used only within the same health institution without transfer to another legal entity (Article 1(5)).

The IVDR replaced that general exclusion with the conditions of Article 5(5); what else changed is compared under IVDD vs IVDR.