OBJECTIVES: The New Regulations on Medical Devices, Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), are recently under implementation period for Turkey. Turkish Medicines and Medical Device Agency (TMMDA) welcomes implementation to ensure better protection of public health and patient safety. This study analyses how the new regulations would impact medical devices sector in Turkey, both from industry and public perspectives.

METHODS: Regulations, literature regarding the regulatory changes, Turkish public and industry acts and relevant reactive publications were reviewed. The review complimented by interactions with different stakeholders to further explore the impact.

RESULTS: Regulations contain a series of important improvements to modernize the current system. Considering description changes for economic operators and classification rules for products both TMMDA and companies should monitor decisions and papers from EU commission. Translation for Turkish Language completed in cooperation with TMMDA and Trade Associations. New definitions for economic operators/Person responsible at medical device industry should assign their roles after TMMDA will clearly define for Turkish market. The conformity assessment process for medical devices will change,Notified Body (NB) designations should be able to complete at a time consistent with the EU for local NBs. Turkish Medical Device database will be expected to recognize and comply with European database as the registrations already will be transferred. Other changes for clinical trials, classification rules, post marketing surveillance should discuss within industry sessions and surveys for better understanding and timely adaptation.

CONCLUSIONS: Draft Turkish Regulation presented to the EU Commission should be continued to work in harmony with and cooperation with industry during the interpretation of it's effects and action plans. The adaptation of the regulation which is sufficiently comprehensive should be carried out within the framework of a plan within cooperation with the industry, taking into consideration the products on the market and the new products to come.