As it is known, Turkey and the European Union (EU) to establish a customs union between the Association council decision 1/95 (ACD) with the technical regulations of the Association council decision no 2/97 of the need to incorporate into domestic law within the scope of Turkey's EU within the medical device is located in product groups (for more details, please click here; decision 1/95 of the Association Council, the Association council decision no 2/97 ). In this context, the EU's medical device legislation (90/385/EEC, 93/42/EEC, 98/79/EC) respectively; The regulation of medical devices and Active Implantable Medical Device Regulation used outside the body (in vitro)as the regulation of medical devices medical devices and thus harmonised between the EU and Turkey in the field of free movement of goods is ensured.
1 of the Decision of the Association Council No. 1/2006 confirming Turkey's compliance with the EU's medical device legislation as a result of the work done in this direction.the article on the implementation of the customs union Joint Committee (GBOK) expression is regulated, and the medical device legislation in this direction, within the scope of the authorized representative of the European Union have the same rights and obligations as the ones resident resident of the fact that it was signed (please click here for more detailed information; Association Council Decision No. 1/2006, GBOK Statement). In this way, deficiencies in the point of regulatory compliance between Turkey and the EU in the field of medical devices have been decoupled and differences in practice have been eliminated.
For you to continue the process in full compliance with the new EU Medical Device Regulations in the EU as of the date of the application, in our country, in order to be valid as a result of harmonisation efforts conducted in conjunction with the European Commission (EU) Medical Device Regulation 2017/745 of the draft statute prepared in parallel with the numbered statement that is fully compatible GBOK was signed on 21/05/2021 ( see fig. October-1 ). Subsequently, the relevant Regulation was published in the Official Gazette dated 02/06/2021 and numbered 31499 (Duplicate) and entered into force as of 26/05/2021. In addition, the GBOK Declaration on the full compliance of the draft Regulation on Medical Devices for In Vitro Diagnostics, prepared in parallel with Regulation (EU) No. 746 of 2017/2021, was signed on 13/09/2021 (see Annex). Annex-2) The said Regulation has also been published in the Official Gazette dated 02/06/2021 and numbered 31499 (Duplicate) and will be implemented as of October 26/05/2022.
Accordingly, the GBOK declarations signed as a result of Turkey's full compliance with the current medical device legislation of the EU and the Decisions of the Association Council remain in force, and the issues in the relevant Association Council Decisions, including mutual recognition of the rights of authorized representatives resident in Turkey, remain valid.
The relevant issue is announced to the public.
Source: https://www.titck.gov.tr/duyuru/tcokka-tibbi-cihazlar-alanindaki-yetkili-temsilciler-18102021223612
18 Oct 2021
