Classification, Clinical Evaluation (CER), and ÜTS Registration Guide for Manufacturers and Importers
Part 1: Regulatory Shift and Risk-Based Classification System
1.1. Core Dynamics of the Transition from MDD to MDR
The Medical Device Directive (MDD – 93/42/EEC), which applied for many years in the European Union and Turkish medical device markets, has been replaced by the much stricter, transparent, and traceability-oriented Medical Device Regulation (MDR – 2017/745). As a result of the harmonization processes carried out by the Republic of Türkiye Ministry of Health and the Turkish Medicines and Medical Devices Agency (TİTCK), compliance with this new regulation is a legal obligation for all medical devices manufactured in or imported into our country.
The fundamental philosophy brought by the MDR is to secure not only the pre-market safety of devices but also their clinical performance, cybersecurity, and Post-Market Surveillance (PMS) throughout their Total Product Life Cycle.
1.2. Rule-Based Classification and Annex VIII Methodology
According to MDR Article 51, medical devices are evaluated into four basic classes based on their intended use, duration of contact with the body, and the level of risk they pose: Class I, Class IIa, Class IIb, and Class III. The risk level increases from Class I to Class III. The 22 rules under MDR Annex VIII provide a rule-based model for the classification of devices:
Non-Invasive Devices (Rules 1-4): Devices used outside the body, or those that store/channel blood or bodily fluids.
Invasive Devices (Rules 5-8): Temporary, short-term, and long-term devices that enter through body orifices or are surgically implanted.
Active Devices (Rules 9-13): Diagnostic or therapeutic active systems operated by electrical energy or another source of power.
Special Rules (Rules 14-22): Rules regulating specific areas such as nanomaterials, drug-device combinations, and disinfection systems.
| Product Class | Risk Level | Example Medical Devices | Notified Body Audit |
| Class I | Low Risk | Wheelchairs, stethoscopes, examination lamps, simple bandages | No (Unless sterile, measuring, or reusable) |
| Class I (s, m, r) | Low-Medium Risk | Sterile surgical gloves (Is), manual blood pressure monitors (Im), surgical scissors (Ir) | Yes (Only sterilization, measurement, or reprocessing is audited) |
| Class IIa | Medium Risk | Hearing aids, diagnostic ultrasound probes, surgical gloves | Yes (The entire quality management system and technical file are audited) |
| Class IIb | High-Medium Risk | Incubators, dialysis machines, bone screws, ventilators | Yes (TİTCK expert review and clinical data auditing are intensive) |
| Class III | High Risk | Pacemakers, coronary stents, hip prostheses, artificial heart valves | Yes (Design examination and the highest level of clinical evidence obligation) |
Part 2: Clinical Evaluation Report and the 10-Step CE/ÜTS Process
2.1. Clinical Evaluation Report (CER): Evidence-Based Safety
One of the most critical building blocks of the MDR regulation is the Clinical Evaluation Report (CER). Under the MDR, it is mandatory to prepare and continuously update a clinical evaluation report for every medical device, including the lowest-risk Class I devices.
The CER is a living document demonstrating that the device is safe and effective in accordance with its declared intended use, and that the risk-benefit balance works in favor of the patient. The core methodologies to be followed when preparing a CER are:
Equivalence Analysis: Comparing the device with an equivalent reference device (biologically, technically, and clinically fully compatible) available on the market.
Systematic Literature Review: Reporting literature gaps regarding the performance of the device or similar technologies using accurate keywords and databases (PubMed, Medline, etc.).
Clinical Investigations: It is a legal obligation to conduct direct human-participant clinical investigations for Class III and implantable devices.
Periodic Updates: The Clinical Evaluation Report must be updated at least once a year for Class III and implantable products, and at regular intervals for other classes.
2.2. 10 Steps for Notified Body and ÜTS Registration
To manufacture and legally sell medical devices in Türkiye and the EU market, and to pass customs processes, the CE mark and Product Tracking System (ÜTS) registration are mandatory. The 10 steps that manufacturers and importers must follow in this process are listed below:
MDR Scope and Compliance Check: Verifying whether the product fits the definition of a “medical device” or “accessory” under MDR Article 2.
Determination of Risk Class: Clarifying the risk class of the product (I, IIa, IIb, III) based on the 22 rules in Annex VIII.
Establishment of ISO 13485 Quality Management System: Structuring and certifying a system compatible with international quality management standards, which is mandatory for medical device manufacturers.
Preparation of MDR-Compliant Technical Documentation: Uniquely creating files for product design, technical specifications, biocompatibility tests, electrical safety tests, and ISO 14971-compliant risk analysis.
Completion of the Clinical Evaluation Report (CER): Adding the efficacy and safety report of the device to the technical documentation in light of literature reviews and clinical data.
Obtaining the Basic UDI-DI Code and EUDAMED Registration: Procuring global identifier codes for device traceability and acquiring the Single Registration Number (SRN) belonging to the manufacturer.
Notified Body Audit: Carrying out the technical file and manufacturing facility audit with an accredited audit organization for all devices except Class I (non-sterile/non-measuring) to obtain the EC Certificate.
Issuance of the EU Declaration of Conformity (DoC): Preparing the document with a physical or electronic signature, where the manufacturer officially declares that the device fully complies with the MDR 2017/745 regulation.
ÜTS Company and Document Registration: Submitting the approved CE certificate, Turkish user manual, and declaration of conformity for TİTCK expert review after completing company registration in the Ministry of Health Product Tracking System (ÜTS).
ÜTS Product Registration and GTIN-14 Barcode Identification: Registering each product into the system with a 14-digit GTIN barcode number, GMDN code, and label visuals based on the approved documents to bring it to “Registered in the System” status.
2.3. Conclusion and Sectoral Evaluation
Although the Medical Device Regulation (MDR) has increased the clinical and technical obligations on manufacturers, it has raised standards in the global market and elevated patient safety to the highest level. Legally, it is impossible to sell a product whose ÜTS registration is incomplete in our country, enter public tenders, or import it through customs. Therefore, carrying out all processes with academic precision and expert technical guidance is of critical importance.