The IVDR in-house exemption and what it costs to rely on

A health institution established in the Union may manufacture and use its own in vitro diagnostic device without applying most of Regulation (EU) 2017/746. Article 5(5) disapplies the requirements of the Regulation for devices manufactured and used only within such institutions, with the exception of the relevant general safety and performance requirements set out in Annex I.¹ It makes that relief conditional on nine points, of which point (d) applies only from 31 December 2030.¹ The conditions are cumulative. Where one of them fails, the device falls back into the ordinary regime for a device put into service.

The scope of the relief

Article 5(4) provides that devices manufactured and used within health institutions are considered as having been put into service, with the exception of devices for performance studies.¹ That characterisation matters, because Article 5(1) permits a device to be placed on the market or put into service only if it complies with the Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.¹ Article 5(2) requires the device to meet the Annex I general safety and performance requirements that apply to it, taking its intended purpose into account, and Article 5(3) requires demonstration of conformity to include a performance evaluation in accordance with Article 56.¹

Article 5(5) lifts the remainder of the Regulation for qualifying in-house devices while leaving the relevant Annex I requirements in place.¹ Article 48 carries the same carve-out into conformity assessment. Article 48(1) requires manufacturers to assess conformity under Annexes IX to XI before placing a device on the market, and Article 48(2) extends that duty to devices put into service without being placed on the market, with the exception of in-house devices manufactured pursuant to Article 5(5).¹ A qualifying in-house device therefore involves no notified body and no conformity assessment procedure under Annexes IX to XI.

The nine conditions in Article 5(5)

The exemption applies only where all of the following conditions are met.¹

• The devices are not transferred to another legal entity.
• Manufacture and use of the devices occur under appropriate quality management systems.
• The laboratory of the health institution is compliant with standard EN ISO 15189. Where applicable, national provisions apply instead, including national provisions regarding accreditation.
• The health institution justifies 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 health institution provides information on the use of such devices to its competent authority upon request, including a justification of their manufacturing, modification and use.
• The health institution draws up a declaration and makes it publicly available, covering the name and address of the manufacturing health institution, the details necessary to identify the devices and a statement that the devices meet the Annex I general safety and performance requirements.
• For class D devices under the Annex VIII rules, the health institution draws up documentation on the manufacturing facility, the manufacturing process, and the design and performance data of the devices, including the intended purpose.
• The health institution takes all necessary measures to ensure that all devices are manufactured in accordance with that documentation.
• The health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.

When each condition started to apply

The conditions did not all take effect with the Regulation. Article 113(3)(i) defers Article 5(5), points (b), (c) and (e) to (i), to 26 May 2024.¹ The following have all been binding since that date.

• the quality management system condition
• the laboratory compliance condition
• the competent authority information duty
• the public declaration
• the class D documentation duties
• the review of clinical experience

Article 113(3)(j) defers point (d), the justification that no equivalent device on the market meets the target patient group’s needs, to 31 December 2030.¹ Point (a), the prohibition on transfer to another legal entity, was not deferred and has applied since the Regulation’s general date of application of 26 May 2022 under Article 113(2).¹

The deferral of point (d) is the one date most likely to be misread. Until 31 December 2030 the institution is under no Article 5(5) obligation to document the absence of an equivalent commercial device. From that date the justification becomes a condition of the exemption itself, which means an in-house test that duplicates an available CE-marked device loses the basis for the relief.

The limit on transfer between legal entities

Point (a) sets the hardest boundary of the exemption. The devices must not be transferred to another legal entity, and Article 5(5) opens by limiting the relief to devices manufactured and used only within health institutions established in the Union.¹ Group structures, university-hospital arrangements and shared laboratory companies each turn on the identity of the legal person rather than on the clinical or administrative relationship between the sites. Sending a test to a separate legal entity places the device outside Article 5(5) and back under Article 5(1) and Article 48.

Quality management and laboratory compliance

Points (b) and (c) are separate requirements. Point (b) requires manufacture and use of the devices to occur under appropriate quality management systems, without naming a standard.¹ Point (c) addresses the laboratory rather than the device. It requires compliance with EN ISO 15189 or, where applicable, national provisions including national provisions regarding accreditation.¹ The alternative reference to national provisions means the operative benchmark may differ between Member States, and both conditions have applied since 26 May 2024 under Article 113(3)(i).¹

The public declaration and stated gaps against Annex I

Point (f) requires a declaration that the institution makes publicly available.¹ Beyond identifying the institution and the devices, the declaration states that the devices meet the Annex I general safety and performance requirements. Where applicable, the same provision requires the declaration to state which requirements are not fully met and to give a reasoned justification.¹ The publicity element is part of the condition. A declaration held internally does not satisfy point (f).

Documentation for class D devices

Point (g) applies to devices that are class D under the Annex VIII classification rules. The documentation must allow an understanding of the manufacturing facility, the manufacturing process, and the design and performance data of the devices, including the intended purpose, and must be detailed enough for the competent authority to ascertain that the Annex I requirements are met.¹ Point (h) requires the institution to take all necessary measures to ensure all devices are manufactured in accordance with that documentation.¹ Article 5(5)(g) also permits Member States to apply the documentation requirement to class A, B or C devices under the Annex VIII rules, so the practical scope of point (g) is a national question.¹

Review of clinical use

Point (i) requires the health institution to review experience gained from clinical use of the devices and to take all necessary corrective actions.¹ This is the surveillance element of the exemption, and it has applied since 26 May 2024. It stands in place of the post-market surveillance and vigilance chapters of the Regulation, which form part of the requirements disapplied by Article 5(5) where the conditions are met.

What Member States may add

Article 5(5) reserves several powers to Member States, and three of them sit in the closing subparagraphs of that paragraph. They may require health institutions to submit any further relevant information about in-house devices manufactured and used on their territory.¹ They retain the right to restrict the manufacture and use of any specific type of such device. They are also permitted access to inspect the activities of the health institutions.¹ An institution relying on the exemption therefore operates under a national layer that the Regulation does not standardise.

Devices manufactured on an industrial scale

The final subparagraph of Article 5(5) states that the paragraph does not apply to devices that are manufactured on an industrial scale.¹ Article 5 contains no definition of industrial scale. The exclusion operates independently of the nine conditions, so volume and manufacturing method can remove a device from the exemption even where every condition in points (a) to (i) is satisfied.

Questions people also ask

Does an in-house IVD need a notified body or a CE mark under the IVDR?

No, where the conditions of Article 5(5) are met. Article 48(2) requires conformity assessment under Annexes IX to XI before a device that is not placed on the market is put into service, and it expressly excepts in-house devices manufactured pursuant to Article 5(5).¹ The relevant Annex I general safety and performance requirements continue to apply to the device.¹

Can a hospital supply its in-house test to another hospital in the same group?

Article 5(5)(a) requires that the devices are not transferred to another legal entity.¹ Where the receiving hospital is a separate legal person, the transfer takes the device outside the exemption, regardless of shared ownership or common management. The device would then be subject to Article 5(1) and to the conformity assessment procedures in Article 48.¹

When does the requirement to show that no equivalent device exists start to apply?

Article 113(3)(j) sets the date of application for Article 5(5), point (d), at 31 December 2030.¹ Until that date the exemption does not depend on documenting that an equivalent device available on the market cannot meet the target patient group’s needs. The other conditions in points (b), (c) and (e) to (i) have applied since 26 May 2024 under Article 113(3)(i).¹

Does the exemption cover devices used in performance studies?

Article 5(4) provides that devices manufactured and used within health institutions are considered as having been put into service, with the exception of devices for performance studies.¹ Article 48(11) subjects devices for performance studies to the requirements set out in Articles 57 to 77.¹

Do Member States have any say over in-house devices?

Yes. Article 5(5) allows Member States to require the submission of further relevant information about in-house devices manufactured and used on their territory, retains their right to restrict the manufacture and use of any specific type of such device, and permits them access to inspect the activities of health institutions.¹ Member States may also extend the class D documentation requirement in point (g) to class A, B or C devices.¹

Footnotes

1. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Consolidated version of 2025-01-10. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³ ↩¹⁴ ↩¹⁵ ↩¹⁶ ↩¹⁷ ↩¹⁸ ↩¹⁹ ↩²⁰ ↩²¹ ↩²² ↩²³ ↩²⁴ ↩²⁵ ↩²⁶ ↩²⁷ ↩²⁸ ↩²⁹ ↩³⁰ ↩³¹ ↩³² ↩³³ ↩³⁴