The Turkish Medicine and Medical Devices Authority (“TITCK”) recently issued a new Medical Devices Regulation (the “New Regulation”) revising the main framework governing the safety, marketing and clinical studies of medical devices. The New Regulation aims to align Turkish rules with the Medical Devices Regulation of the European Union (no. 2017/745). The New Regulation entered into force on 2 June 2021 and repeals the former Medical Device Regulation, which had been in effect since 7 June 2011.
The New Regulation emphasises the concept of product safety and quality and introduces the following major changes:
- The scope of medical devices has been extended. The following product groups have been included in the scope of the Regulation (in Annex XVI):Contact lenses or other devices intended for application in or on the eye;
- Products intended to be applied, in whole or in part, to the human body by surgically invasive means (excluding tattoo products and piercings);
- Substances, combinations of substances or appliances intended for use as a facial or other dermal or mucous membrane filler (excluding tattoo products);
- Equipment intended to reduce, remove or split adipose tissue such as liposuction, lipolysis etc.;
- Equipment that emits high-intensity electromagnetic radiation intended for use on the human body, such as lasers and intense pulsed light (IPL); and
- Equipment for brain stimulation that applies electrical currents or magnetic or electromagnetic fields.
- It is envisaged that the common specifications required for the Annex XVI product groups above will become applicable 6 months after such specifications are published by the European Commission. Until that date, the placing of such products on the Turkish market will be carried out according to the regulations to which they are currently subject.
- Conformity assessment processes have been tightened with more detailed rules.
- Additional major obligations have been introduced for manufacturers, such as hiring a regulatory compliance officer and conducting clinical evaluations of the safety and performance of medical devices (with the exception of customised devices); in addition, more detailed provisions are promulgated regarding the obligation for manufacturers to establish a risk management system, quality management system and post-market surveillance system.
- Before placing a medical device (except for a customised medical device) on the market, the manufacturer must affix a Unique Device Identification (“UDI”) code created in accordance with the rules of an issuing body to the device and, where applicable, to all upper surfaces of the packaging. A UDI code is a series of characters created with internationally accepted device identification and coding standards, allowing precise identification of specific devices on the market. Manufacturers must ensure that information about the medical device is entered and transferred correctly into the UDI database.
- The New Regulation adopts the European Databank on Medical Devices (“EUDAMED”) system of the European Commission for the purposes of monitoring the safety and performance of medical devices. Accordingly, manufacturers are obliged to enter the information about medical devices (except for customised medical devices) into the EUDAMED system before placing them on the Turkish market. The European Commission has announced that EUDAMED will become operational in 2022.
The New Regulation reframes the rules governing the safety and marketing of medical devices in Turkey in line with EU regulations. As such, the New Regulation introduces a stricter regime that particularly affects the areas of regulatory compliance, market oversight and clinical studies, while expanding the product groups to be considered as medical devices.