Navigating TITCK’s Latest Guidance: Which Products Are Excluded from Medical Device Regulations?

In the rapidly evolving landscape of Turkish healthcare regulations, distinguishing between a “medical device” and a “general use product” is critical for manufacturers and importers.

The Turkish Pharmaceutical and Medical Device Agency  (TITCK) recently published a vital announcement regarding products that do not fall within the scope of the Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR).

For regulatory affairs teams and legal counsels, this guidance serves as a definitive checklist to avoid improper registration in the Product Tracking System (ÜTS). Here is a breakdown of the key takeaways from the announcement.

The Core Principle: Intended Use and “Health Claims”

The primary differentiator remains the manufacturer’s intended use.

According to the announcement, products are considered medical devices only if they are intended by the manufacturer to be used for specific medical purposes such as diagnosis, prevention, monitoring, or treatment of disease.

If a product uses the same technology or design as a medical device but is marketed for general use without a specific medical indication, it is not subject to Medical Device Regulations.

Example: A latex glove marketed for “general cleaning” is not a medical device. However, the same glove marketed as an “examination glove” or “surgical glove” is a medical device.

The Exclusion List: What is NOT a Medical Device?

TITCK has provided a specific list of products that, despite their frequent presence in healthcare settings, are excluded from the medical device regulatory scope. These products should not be registered in the ÜTS.

1. Hospital Furniture & Textiles

Even if used within a hospital, standard furniture and textiles are considered general-use items unless they have a specific medical function.

• Office and furnishing materials (chairs, cabinets, mattress protectors, bedsheets).
• Examination screens and curtains.
• Storage cabinets (excluding blood storage cabinets).

2. Hygiene, Cleaning, and Waste Management

Cleaning products are only medical devices if specifically designed to sterilize medical devices.

• General purpose hand/body/surface disinfectants and detergents.
• General cleaning wipes including injection site cleaning wipes.
• Vomit bags produced for general use.
• Corpse bags and morgue units.

3. Personal Care & Cosmetics

Products acting on the external human body for cleaning or perfuming are generally cosmetics, not devices.

• Teeth whitening products such as pastes, gels, lights.
• Sunscreen.
• Menstrual cups.
• Products containing living micro-organisms (probiotics).

4. Laboratory and Research Equipment

Unless specifically intended for In Vitro Diagnostic (IVD) examinations, general lab gear is excluded.

• General laboratory equipment (microscopes, slides, pipettes).
• RUO (Research Use Only): Products labeled for research only, with no diagnostic or therapeutic purpose.
• Chemotherapy drug preparation units.
• Manufacturing equipment (mixers, distillers) used to make drugs or devices.

5. Specific Testing & Protective Equipment

• PPE: Masks, gloves, and overalls designed for personal protection under Personal Protective Equipment regulations rather than patient protection.
• Forensic Tools: Alcohol and drug detection kits used for administrative/legal purposes (e.g., police breathalyzers) rather than medical diagnosis.

Important Note on ÜTS Registration

The announcement explicitly states that Product Tracking System (ÜTS) registration is not required for the products listed above.

Manufacturers and importers must ensure they do not incorrectly register these items as medical devices. The responsibility for the accuracy of product records in ÜTS lies with the registering entity. Misclassification can lead to regulatory audits and potential non-compliance penalties.

Conclusion

This 2026 update clarifies the boundaries of the MDR and IVDR in Turkey. If your company deals with “borderline” products—such as medicated wipes, dual-use laboratory equipment, or hospital infrastructure—it is essential to review your portfolio against this exclusion list.

Contact Us to learn more about how your company can classify the borderline products to decide whether theye are subject to ÜTS registration, visit our website at karacabey.av.tr or contact our legal team for a consultation.

Legal Disclaimer: The information provided in this article is for general informational purposes only and does not constitute legal advice, professional counsel, or a binding legal opinion. While we strive to ensure the accuracy of the content based on the this article, laws and regulations are subject to change and interpretation. Accessing this article does not establish an attorney-client relationship between the reader and Karacabey Legal. We recommend consulting with a qualified attorney regarding your specific legal situation or compliance obligations before taking any action based on this content.