Medical Devices & Health Technologies

Yes, the Turkish Medical Device Regulation in Turkey is exactly compatible with the European Union Medical Device Regulation, even many of the article numbers are the same, it can be said that it is a direct translation of the EU legislation.

The new regulation, effective since June 2, 2021, aims to impose responsibilities on manufacturers, importers, and distributors to establish higher standards for medical device safety, performance, and quality, and to ensure the protection of patients and healthcare professionals.

The regulation sets industry standards, mandates manufacturers to ensure the design, development, manufacturing, labeling, clinical evaluation, and post-market surveillance of medical devices, as well as to document conformity and prepare technical files.

Medical devices are classified into four risk classes: Class I (low risk), Class IIa (moderate risk), Class IIb (high risk), and Class III (very high risk), based on their potential to cause harm.

Manufacturers must design and develop safe medical devices, ensure compliant manufacturing, label and package products accurately, conduct clinical evaluations, and perform post-market surveillance. Importers must verify that products comply with legal requirements.

Penalties for non-compliance include warning letters, fines, suspension/withdrawal of certifications, and prohibition of placing the medical device on the market.