Medical Device Regulation in Turkey: What You Need to Know

The healthcare and medical sector in Turkey underwent a significant transformation with the enforcement of the Medical Device Regulation on June 2, 2021. This regulation introduces new responsibilities for medical device manufacturers, importers, and distributors, aiming to establish a higher level of order within the industry. In this blog post, we will delve deeply into the nuances of this crucial regulation in Turkey.

Turkish Medical Device Regulation

Turkey's Medical Device Regulation (effective since June 2, 2021) imposes responsibilities on manufacturers, importers, and distributors. It classifies devices by risk and sets stringent standards for design, manufacturing, labeling, and clinical evaluation. Non-compliance may lead to penalties. This overview emphasizes the importance of legal assistance for businesses navigating this complex regulation.

Scope of the Regulation

The Medical Device Regulation applies to all medical devices that are placed on the Turkish market, including:

• Devices that are intended for human use
• Accessories for medical devices
• In vitro diagnostic medical devices

Fundamental Principles of the New Regulation

The Medical Device Regulation is a comprehensive document that regulates the manufacturing, importation, certifications (CE and ISO) and conformities, distribution, and marketing of medical devices. The regulation sets industry standards with the goal of enhancing product safety, performance, and quality. Simultaneously, it incorporates crucial measures to ensure the safety of patients and healthcare professionals.

Liabilities of Manufacturers and Importers

The regulation outlines detailed responsibilities for medical device manufacturers and importers. Manufacturers are obligated to document the conformity of their products, prepare technical files, and undergo necessary tests and evaluations. Importers, on the other hand, bear the responsibility of ensuring the compliance of products with legal requirements.

Risk Classification

Medical devices are classified into four risk classes based on their potential to cause harm to patients, users, or other persons:

• Class I: Low risk
• Class IIa: Moderate risk
• Class IIb: High risk
• Class III: Very high risk

Requirements of the Regulation

The Medical Device Regulation imposes a number of requirements on manufacturers of medical devices, including:

• Design and development: Manufacturers must ensure that their medical devices are designed and developed in a safe and effective manner.
• Manufacturing: Manufacturers must ensure that their medical devices are manufactured in a controlled and compliant manner.
• Labelling and packaging: Manufacturers must ensure that their medical devices are labelled and packaged in a clear and accurate manner.
• Clinical evaluation: Manufacturers must conduct clinical evaluations of their medical devices to demonstrate their safety and effectiveness.
• Post-market surveillance: Manufacturers must conduct post-market surveillance of their medical devices to monitor their safety and effectiveness.

Distribution and Marketing Principles

The Medical Device Regulation includes specific principles to ensure the proper distribution and marketing of products. In this context, adherence to standards related to the promotion, advertising, and sale of medical devices is paramount.

Penalties for Non-Compliance

Manufacturers who fail to comply with the Medical Device Regulation may be subject to a number of penalties, including:

• Warning letters
• Fines
• Suspension and/or withdrawing the certifications and conformities
• Prohibition of placing the medical device on the market

Current Challenges and Solutions in the Industry

Alongside the regulation, certain challenges may arise in the industry. This section will address the current issues faced by professionals in the sector and propose potential solutions to these challenges.

The Medical Device Regulation is a complex regulation that imposes a number of requirements on manufacturers of medical devices. It is important for manufacturers to understand the requirements of the regulation in order to ensure that their medical devices are compliant.

The Medical Device Regulation and Legal Implications

Lastly, we will discuss the legal consequences of non-compliance with the Medical Device Regulation in the sector. This section aims to assist businesses in understanding the precautions they need to take to ensure compliance with the regulations and providing the legal service for dispute resolutions arising from the medical devices.

Contact a Turkish Lawyer for Medical Device

If you are a manufacturer, distributor, producer or license owner of medical devices in Turkey, you should contact a Turkish lawyer for assistance with complying with the Medical Device Regulation. A medical lawyer and litigator who is also practicing product liability law can help you solve the requirements of the regulation, ensure that your medical devices are compliant and/or defend your rights related to the medical device.