The Turkish Medicines and Medical Devices Agency released its national legislation on medical devices in June 2021. In this sense, as per the Customs Union between the EU and Turkey in the medical devices field, the Turkish Medical Device Regulation and Turkish In Vitro Diagnostics Medical Device Regulation are aligned with the content from the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Medical Devices Regulation 2017/746 (IVDR) while also adding national requirements.
As such, the Turkish regulation is characterized by the following aspects:
Authorised Representative, PRRC and Notified Bodies
As per Article 11 of the Turkish law, the Authorised Representative in Turkey can also be based in an EU Member State. Furthermore, this law also incorporates the figure of the Person Responsible for Regulatory Compliance (PRRC), set in Articles 15 Turkish MDR and Article 16 of Turkish IVDR.
This figure of the PRRC is also required for Authorised Representatives established in Turkey. Furthermore, Turkey can designate Turkish Notified Bodies, which are equally valid as the EU Notified Bodies and have the same responsibilities. At the same time, medical devices covered by a certificate issued by an EU Notified Body are also accepted on the Turkish market.
Nevertheless, it’s important to note that it is necessary to follow all relevant EU harmonisation legislation to affix the CE marking to medical devices.
Reprocessing of medical devices
The Turkish national implementation establishes that only single-use devices that have been placed on the market as per the currently applicable Code or in accordance with the Medical Device Code, as revoked by Article 110, can be reprocessed. In these cases, the name and address of the manufacturer of the original single-use device shall no longer appear on the label but needs to be stated in the instructions for the use of the reprocessed device.
National registration of devices
Furthermore, as mentioned in the Turkish national implementation laws, the EUDAMED database also applies to products placed on the Turkish market. Nevertheless, until EUDAMED is fully functional (currently expected to be announced in the second quarter of 2024), performing a pre-market registration in the Product Tracking System (ÜTS) is necessary. This registration applies to all risk groups, including IVDs.
Moreover, the UDI system established in the EU is also applicable to Turkey.
Packaging and language requirements
As stated in Turkish national implementation laws (Article 23 Turkish Medical Device Regulation and Article 20 Turkish In Vitro Medical Devices Regulation), packaging requirements need to be compliant with national requirements. Among others, the following information should be stated on the labels:
- Lot number, followed by the words “LOT NUMBER” or “SERIAL NUMBER”;
- UDI carrier;
- Date of manufacture;
- Net quantity of the content;
- Indication of special storage and/or conditions of use;
Instructions for use are required to be provided with the medical devices, except Class I and IIa devices, if the device is safe without a user manual. Also, instructions for use can also be provided electronically.
Additionally, as per the Turkish national implementation law and the law on Product Safety and Technical Regulation manufacturers need to translate, among others, the following packaging information into Turkish:
- Single-unit packaging
- Sales packaging
- Transport packaging under certain conditions of administration
- Instructions for use (IFUs)
In general, manufacturers should translate all the information on the product or its packaging or in the documents accompanying the product, as well as assembly, use and maintenance instructions and safety rules into Turkish. This applies to all types of devices, irrespective of whether they are used by healthcare professionals or lay persons.
Nevertheless, labels may be provided in English provided that the documents accompanying the product contain the necessary information to avoid the risk, while the assembly, use and maintenance instructions and safety rules are in Turkish.
Penalties
Several penalties are established with regards to the protection of personal data. On the other hand, as stated in Article 103 Tukish IVD law and Article 105 Turkish medical devices law, violations of the provisions stated in the Regulation will be subject to the Turkish Criminal Code.
Are you interested in placing your medical devices and in vitro diagnostic devices on the Turkish market? Do not hesitate to contact us!
References:
Resmi Gazete. (2 June, 2021). Turkiye ilac; ve T1bbi Cihaz Kurumundan: Tibbi Cihaz Yonetmeligi No. 31499.
Resmi Gazete. (2 June, 2021). Turkiye ilac; ve T1bbi Cihaz Kurumundan : In Vitro Tani Amacli Tibbi Cihaz Yonetmeligi No. 31499.
Resmi Gazete. (12 March, 2020). Product Safety And Technical Regulations Law No. 7223.
Turkiye ilac; ve T1bbi Cihaz Kurumu. (2023). New Medical Device Regulations.
European Commission. (March, 2022). Notice to Stakeholders: EU-Turkey Customs Agreement in the Field of Medical Devices.
EUR-Lex. (5 April, 2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.
EUR-Lex. (5 April 2017). Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.
Ministry of Trade Turkey. (21 May, 2021). Statement of the EU-Turkey Customs Union Joint Committee on the implementation of Decision 1/2006 of the EC-Turkey Association Council of 21.5.2021.
Ministry of Trade Turkey. (13 September, 2021). Statement of the EU-Turkey Customs Union Joint Committee on the implementation of Decision 1/2006 of the EC-Turkey Association Council of 13.9.2021.
European Commission. (June, 2022). EUDAMED Timeline.
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