On 30 October 2023, the Turkish Medicines and Medical Devices Agency (Agency) published an announcement (Turkish language) regarding products that are not considered within the definition of medical device or the scope of the legal framework. The Agency stated that, while some products which were considered medical devices or in vitro diagnostic devices under the legislation repealed by the EU Regulations 2017/745 and 2017/746 are excluded from the scope of the medical device regulations, some new product groups are introduced as medical devices or in vitro diagnostic devices. In this respect, it is important to be aware of the legislation governing the products to be placed on the market in line with the new regulations.
Accordingly, the Agency stated that products that are placed on the market with a health claim for medical use and that perform as per the definition of medical device provided in the Turkish Medical Device Regulation (Regulation) should be evaluated within the scope of the Regulation and registered to the Product Tracking System. The Agency also provided a list of products that are not considered as medical device, including:
- Examination screens or curtains, or radiation protective screens.
- Transport trolleys, emergency response trolleys, storage cabinets (except blood storage cabinets) supplied to the market for the transportation and protection of drugs, or medical devices.
- Products for general laboratory use (microscopes, pipette-pipette tips and so on) which are not specifically intended by their manufacturers to be used for in vitro diagnostic examination.
- Products placed on the market for research use only (RUO) which, although used in vitro, are not intended for use as part of a diagnosis or treatment.
First published by Practical Law Life Sciences Monthly Newsletter in Dec 07, 2023.