A Field and International Standards Perspective on the 2025 Medical Laboratory Regulation

What Changes Does the 2025 Medical Laboratory Regulation Bring?

While medical laboratories in Türkiye were preparing for the 2024 Medical Laboratory Regulation by June 2026, a new regulation with a changed scope was published on October 24, 2025. It entered into force on the day of its publication. Besides medical (clinical) laboratories, genetic laboratories, R&D laboratories, external quality assessment program providers, and medical laboratories providing training were also included within the scope of this regulation. This situation has sparked considerable debate, particularly among competent individuals who understand the separation and interaction of research, service, and education fields.

As someone who has been involved at national and international levels in the creation, development, and publication processes of the TS EN ISO 15189 “Medical Laboratories – Requirements for Quality and Competence” Standard, I would like to share the following point:

Initially, the term "clinical laboratory" was used. However, because this term did not adequately express the medical field, the term "medical laboratory" was adopted; and it was explicitly added to the definitions and explanations that the ISO 15189 Standard is specific to laboratories providing clinical services.

We wanted to present the 2025 Regulation, which is astonishing in terms of scientific rigor and applicability, for evaluation based on legal regulations, ISO 15189 standards, and information gathered from the field. The interview video can be accessed via the URL at the end of the article. Below is a summary of the discussions, highlighting the main points:

Assessment in Terms of Specificity, Applicability, and Digitalization

Published on October 24, 2025 “"Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Applications" (2025 Medical Laboratory Regulation), The regulation was presented as a significant milestone in the field of medical laboratories. It expanded the scope by repealing previous regulations, bringing genetic, advanced technology, and research and development activities, in addition to diagnostic laboratories, under the same framework.

However, when viewed from the field, from standards, and from international practices, this expansion... Certainty, risk-based approach, and feasibility. It appears that this also raises serious questions.

This article discusses the regulations. legal structure, ISO 15189 compliance, field applications And digital health perspective It is discussed from this perspective.

With the 2025 Medical Laboratory Regulation, the inspection approach will be "“How is it implemented in the field?”It seems to be shifting towards the "..." axis. This may be a correct orientation in principle. However, the fundamental problem here is: Regulations that do not clearly define how they should be implemented produce differing interpretations rather than uniformity of application in the field; this can create significant risks to patient safety.

The regulation is quite comprehensive in terms of its articles, paragraphs, and clauses. However:

• It is challenging to track which article and paragraph the clauses are based on.,
• Multiple different topics are addressed together in a single article.,
• Definitions are not always consistent with scientific and international terminology.

This situation places a significant burden on laboratories, especially during the preparation process.

Definitions: Without conceptual clarity, practice and patient safety can be jeopardized.

One of the most critical elements for the effective and safe implementation of a regulation is that definitions are clear, consistent, and predictable. While the definitions of medical diagnostic laboratories in the 2025 Medical Laboratory Regulation appear to be largely consistent with international practices, ambiguities are particularly noticeable in the following areas:

• R&D laboratories,
• Reference laboratories,
• Treatment laboratories,
• Advanced medical laboratory applications.

For example:

• An organization both control both consultancy Having this function could create a risk of conflict of interest.
• Is the criterion of being relevant to human health sufficient on its own to include R&D activities within the scope of clinical diagnostic laboratories?
• Why have the lines between diagnostic, investigative, and therapeutic activities become so blurred?

These questions are not just theoretical; legal certainty, equality in oversight And patient safety It is also critically important from that perspective.

Viewed from the perspective of ISO 15189

ISO 15189 is a standard specifically developed for medical diagnostic laboratories. Experimental and research laboratories, on the other hand, are evaluated under the "TS EN ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories".

The 2025 regulation, however, does not clearly take this distinction into account. It places R&D activities under the same administrative and supervisory framework as diagnostic laboratories, without considering their risk level and purpose.

• A broad interpretation of the limits of authority,
• Purpose-basis incompatibility,
• Divergence from international practices

This brings with it risks.

Physical Criteria: Square Meter or Risk-Based?

The regulation defines physical areas with detailed square meter definitions. However, international practices define physical infrastructure as follows:

• test type,
• device specifications,
• risk level,
• functional requirements

It considers it accordingly.

Square meter-based approach:

• It ignores the diversity of laboratories and differences in scale,
• It leads to a significant loss of time and energy during inspections,
• It prioritizes aesthetic conformity over improving quality.

Personnel and Competence: One of the Most Critical Deficiency Areas

The regulation defines personnel terms; however, competence and proficiency It does not adequately address these concepts.

A person having a specific diploma makes them eligible for that test and that device. competent This does not mean otherwise. One of the strongest aspects of ISO 15189 is;

• documentation of competence,
• monitoring of performance,
• ensuring continuity
  It is mandatory.

This deficiency becomes even more apparent in a regulation that specifically emphasizes "advanced technology.".

Information Systems and Digitalization: Opportunity or Risk?

Information systems, data protection and storage are detailed in the regulation. This is a positive step. However, information systems are not limited to:

“Approaching it as merely a "record keeping and control tool" carries a serious risk.

This approach:

• Data integration,
• Traceability,
• Data-driven decision-making,
• The healthy use of artificial intelligence and decision support systems.

long-term limits.

Information systems are not a technology;, transformation tool should be considered as such.

Voice from the Field: What Do the Survey Findings Say?

An evaluation survey conducted with participants from laboratories of different sizes and types revealed the following perception regarding the regulation:

• Predictability is low.,
• The risk-based approach is weak.,
• Implementation clarity is insufficient.,
• R&D and the transition process are the most problematic areas.

The fact that R&D, reference, and advanced technology activities are all handled within the same regulatory framework has been the subject of the most criticism.

Conclusion: Good Intentions, Structural Issues Needing Improvement

The main objective of the 2025 Medical Laboratory Regulation is... human health and patient safetyThis goal is undeniably correct. However, the way to achieve this goal is not through ambiguity, room for interpretation, and formalism;

• from clear definitions,
• from a risk-based approach,
• compliance with international standards,
• applicability in the field

It is passing.

While the aim is to strengthen patient safety, it is evident that existing regulations need to be structured in a clearer, risk-based, and field-implementable way to support this goal.

The purpose of the interview, the summary of which is presented, is not so much to criticize; to contribute to improvement. As academics, experts, and field professionals, we are always ready to take responsibility for constructively improving this process.

Kind regards…

Prof. Dr. Diler Aslan

ORCID ID: 0000-0003-4907-9445

February 6, 2026

Access to video:

Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Applications (Aslan D, Sözmen E, Eker P.)https://www.youtube.com/watch?v=DEWkGmvYa9U)