Under the framework of Decision No 1/95 of the EC-Türkiye Association
Council, which established the Customs Union between Türkiye
and the European Union (EU), and Decision
No. 2/97, Türkiye is required to incorporate the technical regulations of
the EU into its domestic law for certain product groups, including medical
devices. As a result of the alignment efforts
with the EU regulations in this context, the EU's medical devices legislation
(90/385/EEC, 93/42/EEC, 98/79/EC) have been harmonized as follows: the
Directive on Active Implantable Medical Devices, the Medical Devices Directive,
and the In Vitro Diagnostic Medical Devices Directive, respectively. This
harmonization has enabled the free movement between the EU and Türkiye in the
field of medical devices.
Furthermore, Decision No. 1/2006 has regulated the notification of Conformity
Assessment Bodies established in Türkiye, and the results of conformity
assessment conducted in accordance with the procedures by Conformity Assessment
Bodies, after the completion of the notification process, are mutually
recognized in Türkiye and the EU without any additional requirements.
In the context of compliance with the
updated EU medical device regulations, Regulation (EU) 2017/745 of the European
Parliament and of the Council of 5 April 2017 on medical devices and Regulation
(EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on
in vitro diagnostic medical devices,
have been harmonized and entered into force in Türkiye (for Turkish Medical
Devices Regulation, see: https://www.mevzuat.gov.tr/mevzuat?MevzuatNo=38657&MevzuatTur=7&MevzuatTertip=5, for Turkish In Vitro Diagnostic Medical
Devices Regulation, see: https://www.mevzuat.gov.tr/mevzuat?MevzuatNo=38658&MevzuatTur=7&MevzuatTertip=5 ).
The
two statements of 21 May 2021 and 13 September 2021 confirming the alignment of
the Turkish Medical Devices Legislation with EU Regulations state that "Whenever
the EU instrument listed above [i.e. Regulations 2017/745 or 2017/746] and the
relevant Turkish provisions giving effect to that instrument contain references
to the territories of the Parties, the references shall, for the purpose of
Decision No 1/95 of the ЕС-Türkiye Association Council, be understood to
comprise the territory of the EU-Türkiye Customs Union." In line with
this, the references in the EU regulations numbered 2017/745 or 2017/746 and
the relevant Turkish legislation that enacts these regulations (Medical Devices
Regulation or In Vitro Diagnostics Medical Devices Regulation) contain
references to the territories of the Parties, encompassing the territory of the
EU-Türkiye Customs Union, in accordance with Decision No. 1/95 of the EU-Türkiye
Association Council.
In
light of this information, manufacturers established in the EU have no
obligation to designate an authorized representative in Türkiye to place medical
devices on the Turkish market. Similarly, manufacturers established in Türkiye have
no obligation to designate an authorized representative in the EU to place
medical devices on the EU market. Therefore, manufacturers established outside
the territory of the EU or Türkiye only need to designate one authorised
representative, either in the EU or in Türkiye, in order to place medical
devices on the market in the EU or in Türkiye.
Furthermore,
an notified body established in Türkiye has the same rights and obligations as
an notified body established in the EU. Medical devices covered by a
certificate duly issued by a Turkish notified body may be placed on the EU
market. Vice versa, medical devices covered by a certificate duly issued
by a notified body established in the EU may circulate freely in Türkiye.
Please also see the notice
published by the European Commission on this issue.
Attachment:
1. Statement of the EU-Türkiye Customs
Union Joint Committee on the implementation of Decision 1/2006 of the EC-
Türkiye Association Council of 21.5.2021 (concerning Regulation (EU) 2017/745
of the European Parliament and of the Council of 5 April 2017 on medical
devices).
2. Statement of the EU- Türkiye Customs
Union Joint Committee on the implementation of Decision 1/2006 of the EC-
Türkiye Association Council of 13.9.2021 (concerning Regulation (EU) 2017/746
of the European Parliament and of the Council of 5 April 2017 on in vitro
diagnostic medical devices).