Most of the regulatory debate over the past years has focused on manufacturers under the In Vitro Diagnostic Regulation (IVDR). For laboratories, however, one provision has always been central: Article 5(5), the in-house exemption. With the proposed revision of the IVDR, often referred to as IVDR 2.0, this article is again under scrutiny. Depending on how the legislative process unfolds, the proposed changes could significantly affect how health institutions across the EU develop, document, and use in-house IVDs.

The Current Article 5(5) Framework

Under the current framework, in-house IVDs are exempt from CE marking, but only under clearly defined conditions. An in-house device must be manufactured and used solely within a health institution and cannot be transferred to another legal entity. It must comply with the General Safety and Performance Requirements set out in Annex I of the IVDR, and it must be developed and used under an appropriate quality management system. Oversight lies with national competent authorities rather than notified bodies, meaning laboratories remain directly accountable for demonstrating compliance.

In practice, this means that laboratories must maintain product-specific documentation for each in-house device and ensure that they can demonstrate compliance with the Annex I requirements. This includes performance evaluation elements such as scientific validity, analytical performance, and clinical performance, as well as risk management and post-market surveillance activities. Compliance with ISO 15189 is mandatory, but it does not replace IVDR obligations. Guidance such as MDCG 2023-1 has clarified certain aspects, yet interpretation still varies between Member States, particularly when it comes to definitions and practical enforcement.

Another key element of the current framework is the justification requirement scheduled to apply from 2030. Laboratories would have been required to justify the use of an in-house device if an equivalent CE-marked device was available on the market. This provision has been widely discussed and, in many cases, criticized for its practical implications.

Why IVDR 2.0?

The broader context is important. Both the IVDR and its sibling, the Medical Device Regulation (MDR), were adopted in 2017. Since their adoption, practical experience has revealed significant structural challenges. These include administrative burden, limited notified body capacity, complex transition timelines, and areas where regulatory expectations proved difficult to operationalize.

In response, the European Commission initiated a targeted evaluation process, which evolved into a formal legislative revision proposal. The objective is not to dismantle the IVDR framework but to recalibrate specific elements where experience has shown friction. The proposal is currently undergoing the ordinary EU legislative procedure, meaning that both the European Parliament and the Council may introduce amendments. Even under optimistic assumptions, adoption is unlikely before mid-2027, followed by a transitional period. Laboratories should therefore treat the current proposal as exactly that: a proposal, not yet final law.

What Remains Unchanged

One important clarification is that Article 5(5) itself is not being removed. The in-house exemption remains part of the regulatory architecture. In-house devices would continue to be exempt from CE marking, the General Safety and Performance Requirements would continue to apply, an appropriate quality management system would still be mandatory, and competent authorities would retain the right to inspect and request documentation.

In other words, the proposal does not eliminate regulatory responsibility for laboratories. The underlying philosophy remains that in-house manufacturing is possible under specific conditions, but it must be controlled, documented, and defensible.

Transfer to Other Legal Entities

One of the most significant proposed changes concerns the strict prohibition on transfer to other legal entities. Under the current regulation, in-house devices must remain within the legal entity that manufactured them. The proposal introduces a conditional exception that would allow transfer where it serves a duly justified interest of public health.

Although the wording remains broad, the intention appears to address practical scenarios where specialized laboratories develop assays that are not widely available, such as diagnostics for rare or highly specialized conditions. In such cases, collaboration between health institutions could become legally feasible, provided that the public health rationale is properly documented. Competent authorities would retain oversight and could review the justification. How this concept of “duly justified interest of public health” will be interpreted in practice will likely depend on future guidance and national enforcement approaches.

Removal of the CE-Marked Alternative Justification

Another major proposed change is the removal of the future obligation to justify the use of an in-house device when an equivalent CE-marked device is available. This requirement, originally scheduled to apply from 2030, would disappear entirely under the proposal.

The initial logic behind the requirement was to prioritize CE-marked devices as the default option, assuming that full conformity assessment provides a higher level of regulatory assurance. However, in practice, this would have required complex and potentially contentious equivalence assessments by laboratories and competent authorities. The Commission appears to have concluded that the administrative burden and enforcement complexity outweigh the regulatory benefit. If adopted in its current form, this change would significantly reduce uncertainty for laboratories and eliminate a potential compliance cliff edge in 2030. That said, this aspect may still be subject to political debate during the legislative process.

Quality Management System Expectations

The proposal maintains the requirement for compliance with ISO 15189, reinforcing its role as a baseline for medical laboratory quality and competence. At the same time, the concept of an “appropriate” quality management system remains central. ISO 15189 addresses laboratory processes and competence, but it does not fully cover design and manufacturing controls in the sense understood for medical device manufacturers.

Laboratories developing in-house devices, particularly software-based IVDs, may need to integrate additional design control and lifecycle elements to ensure compliance with Annex I requirements. The expectation is not necessarily full replication of a manufacturer’s quality system under ISO 13485, but it does require structured processes for design, risk management, validation, and change control. The proposal does not radically alter this expectation; rather, it confirms that quality system adequacy must be assessed in light of the specific activities performed.

Documentation and Declarations

The proposal also clarifies the content of the declaration accompanying in-house devices. Laboratories may reference their accreditation status or confirm compliance with the General Safety and Performance Requirements. However, this clarification concerns the format of the declaration rather than the substance of compliance. Annex I obligations remain mandatory. Documentation must exist and be sufficiently robust to withstand competent authority review.

The removal of certain housekeeping provisions in the proposal does not eliminate underlying obligations. Requirements such as ensuring that devices are manufactured in accordance with documented specifications remain intrinsic to the concept of an appropriate quality management system.

Clinical Trial Assays and Health Institution Scope

A further clarification concerns assays used in clinical trials. The proposal explicitly confirms that in-house devices used in the context of clinical investigations fall within the Article 5(5) framework where applicable. This addresses prior uncertainty regarding whether certain trial laboratories qualify as health institutions for the purposes of the IVDR. By clarifying this point, the proposal reduces regulatory ambiguity for sponsors and laboratories involved in clinical research.

What This Means for Laboratories

If adopted largely in its current form, the proposal would provide laboratories with greater flexibility, particularly by removing the 2030 justification requirement and introducing a controlled pathway for inter-institutional collaboration. At the same time, it does not reduce the need for structured documentation, risk management, and quality system discipline. Annex I compliance remains non-negotiable, and competent authority oversight remains intact.

The revision should therefore be understood not as deregulation but as pragmatic correction. Laboratories should continue to comply with the current Article 5(5) requirements while monitoring legislative developments closely. The final shape of IVDR 2.0 will only become clear once the legislative process concludes and updated guidance is published.

To explore the proposed changes to Article 5(5) in more detail — including practical implications, legal nuances, and what laboratories should prepare for now — watch the full on-demand webinar session where we walk through the proposal step by step and share our expert analysis.

You can can get access to the recording inside the PlatoX Academy:

For laboratories navigating the in-house device landscape, understanding where ISO 15189 stops — and IVDR begins — is essential. ISO 15189 defines how work is done. IVDR ensures that the devices behind those procedures are safe, effective, and compliant.

*We have compiled the above information to the best of our knowledge, yet our blog entries do not constitute expert advice and cannot substitute your own examination of the legal situation applicable to you and your institution.