IVDR Article 5(5): In-House Devices in Health Institutions Explained

1. Key takeaways

Article 5(5) sets a conditional exemption for in-house devices manufactured and used by health institutions (in the sector, often called LDTs): apart from the relevant general safety and performance requirements of Annex I, the remaining requirements of the Regulation do not apply to devices manufactured and used exclusively within a health institution established in the EU, provided all nine conditions (a)–(i) are met simultaneously, and the exemption does not apply to devices manufactured on an industrial scale. The conjunctive structure is the defining feature: losing any single condition forfeits the whole exemption. Laboratories and health institutions should therefore treat Article 5(5) as a standing evidence obligation rather than a one-time assessment, because several conditions — the justification of unmet patient needs, the review of clinical experience and the public declaration — must be maintained and updated over the life of each in-house method.

2. Legal basis

3. Expert insights

Insight 1: The nine conditions are conjunctive; missing any one loses the exemption.

The conditions are: (a) the device is not transferred to another legal entity; (b) manufacture and use are carried out under an appropriate quality management system; (c) the laboratory of the health institution complies with the standard EN ISO 15189 or, where applicable, with national provisions of the Member State concerned, including provisions on accreditation; (d) the health institution justifies in its documentation that the specific needs of the target patient group cannot be met, or cannot be met at the appropriate level of performance, by devices available on the market; (e) information on use is provided to the competent authority upon request, including the justification for manufacture, modification and use; (f) the health institution draws up and makes public a declaration containing the name and address of the manufacturing site, the details necessary to identify the devices, a declaration that the devices meet the GSPR of Annex I and, where applicable, the requirements not fully met with the justification; (g) for devices that fall within Class D under Annex VIII, documentation is drawn up sufficient to allow the competent authority to confirm that the GSPR are met (manufacturing facility, manufacturing process, design and performance data, intended purpose), and Member States may extend this requirement to Class A, B and C devices; (h) all necessary steps are taken to ensure that the devices are manufactured in accordance with the documentation referred to in point (g); (i) the clinical experience gained with the devices is reviewed and all necessary corrective actions are taken.

Insight 2: The exemption waives procedure, not safety and performance.

Article 5(5) opens with the words: with the exception of the relevant general safety and performance requirements set out in Annex I. The GSPR of Annex I therefore continue to apply in full. An in-house device still needs performance evidence, risk management and a documented system; what the exemption removes is the notified body route and CE marking, not the substantive quality of the device. Laboratories that treat the exemption as a full carve-out frequently discover the gap when a competent authority exercises its inspection rights under the national provisions of the second and third subparagraphs and asks for the performance data and risk files that point (g) and the GSPR imply.

Insight 3: Industrial scale is a hard exclusion.

The final paragraph of Article 5(5) states expressly: this paragraph shall not apply to devices that are manufactured on an industrial scale. Replicating the same laboratory method at large scale across multiple sites, supplying external samples or moving the device across legal entities all engage both the industrial-scale exclusion and the prohibition in point (a) on transferring the device to another legal entity. Health institutions expanding an in-house test beyond the walls of a single institution should reassess the exemption before scaling rather than afterwards, because the loss of the exemption is not gradual: it removes the entire basis on which the device was manufactured without conformity assessment.

Insight 4: Member States retain additional tightening powers.

The second and third subparagraphs of Article 5(5) allow Member States to require health institutions to submit further information to the competent authority, to retain the right to restrict the manufacture and use of specific types of devices, and to enter and inspect health institutions and their activities. Meeting the nine conditions is therefore not the end of the analysis: the national provisions of the Member State concerned must also be checked, since several countries have added notification duties, registries or additional documentation requirements on top of the Regulation.

4. Practical recommendations

1. Build an evidence file against each of points (a)–(i) with named owners, keeping the experience review of point (i) as a routine, dated record.
2. Confirm whether the laboratory EN ISO 15189 accreditation status and scope cover the method (Article 5(5)(c)).
3. Draw up and publish the declaration of point (f), including any GSPR not fully met and the justification.
4. For Class D methods, compile manufacturing and design documentation submittable to the competent authority under point (g).
5. Track the COM(2025) 1023 simplification proposal for its direction on Article 5(5) — the proposal is not yet adopted and cannot be relied on as current law.

5. Verification checklist

• □ Each of the nine conditions (a)–(i) of Article 5(5) confirmed with evidence retained
• □ Laboratory EN ISO 15189 accreditation status and scope checked (Article 5(5)(c))
• □ Declaration of point (f) drawn up and published, including unmet requirements and justification
• □ Manufacturing and design documentation compiled for Class D methods under point (g)
• □ Confirmed that manufacture is not on an industrial scale (final paragraph of Article 5(5))
• □ Additional national requirements of the Member State concerned checked

Legal information verified as of 2026-10-29.

GRZAN supports in vitro diagnostic manufacturers and health institutions navigating Regulation (EU) 2017/746 as EU Authorised Representative (EC REP) and PRRC provider, including Article 5(5) in-house device evidence files, market-existence justifications, EUDAMED registration support and fee budgeting. For in-house device compliance, contact info@grzanglobal.com.