The European Union Medical Devices Regulation 2017\/745 (“MDR”) came into effect in all member states as of May 26, 2021, after a one-year delay due to the ongoing Covid-19 pandemic. In parallel, the Regulation on Medical Devices and the Regulation on In Vitro Diagnostic Medical Devices of Turkey, which are compliant to the MDR and the EU Regulation on in vitro Diagnostic Medical Devices 2017\/746, and the Communiqué on Annulment of Communiqué on Notified Bodies to Operate in Medical Device Sector has been published in the Official Gazette on June 2, 2021. Accordingly, the Regulation on Medical Devices has entered into force to be effective as of May 26, 2021, and the Regulation on In Vitro Diagnostic Medical Devices will enter into force on May 26, 2022.<\/p>\n
With this respect, Turkish Medicines and Medical Devices Agency (“TITCK”) has published an announcement dated May 25, 2021 to elaborate the scenarios to be applied to Product Tracking System (“ÜTS”) processes concerning the products that have been presented to the market under the scope of the previous regulations that are already registered with the ÜTS as well as the products of which their status have been updated under the new legislation.<\/p>\n
For products that are in a risk class other than Class I-other, of which conformity assessment was<\/strong> performed by a Notified Body<\/strong>;<\/strong><\/p>\n i. If such product is:<\/p>\n – Not compliant with MDR requirements,<\/p>\n – Compliant with MDR requirements with the same barcode but not updated at ÜTS,<\/p>\n – Compliant with MDR requirements with a different barcode;<\/p>\n than it will continue to be registered with ÜTS as long as its current EC certificate is valid. In addition, the movement of individual products registered with ÜTS will be allowed until the end of its shelf life.<\/p>\n ii. If such product is:<\/p>\n – Compliant with MDR requirements with the same barcode and updated at ÜTS,<\/p>\n – Not currently registered with ÜTS and is registered in accordance with MDR requirements;<\/p>\n than it will be allowed to remain registered until the expiration date of its EC certificate. With this respect, as individual products that are compliant with either previous or current EU directives may be presented to the market, the label and user manual prepared in accordance with both the previous and the new legislation should be present with the ÜTS registration. The movement of individual products registered with ÜTS will be allowed until the end of their shelf life. Additionally, it was explained that individual product entry from EU member states will be allowed for 5 years after the expiry of the EC certificate, however, new product registration to the relevant certificate would not be allowed.<\/p>\n For products <\/strong>that are in Class I-other risk class, of which <\/strong>conformity assessment <\/strong>has<\/strong> not<\/strong> been<\/strong> carried out by a Notified Body<\/strong>;<\/strong><\/p>\n <\/strong>i. If such product is:<\/p>\n – Not compliant with MDR requirements,<\/p>\n – Compliant with MDR requirements with the same barcode but not updated at ÜTS,<\/p>\n – Compliant with MDR requirements with a different barcode;<\/p>\n than it will continue to be registered with ÜTS until August 26, 2021. The movement of individual products registered with ÜTS will be allowed until the end of the shelf life.<\/p>\n ii. If such product is:<\/p>\n – Compliant with MDR requirements with the same barcode and updated at ÜTS,<\/p>\n – Not previously registered with ÜTS and is registered in accordance with MDR requirements;<\/p>\n than it will be allowed to remain registered indefinitely, or until the expiration date of the EU Declaration of Conformity, if any. With this respect, as individual products that are compliant with either previous or current EU directives may be presented to the market, the label and user manual prepared in accordance with both the previous and the new legislation should be presented with the ÜTS registration. The movement of individual products registered with ÜTS will be allowed until the end of the shelf life. Additionally, product entry from EU member states will be allowed for 5 years after the expiry of the EU Declaration of Conformity.<\/p>\n For products that <\/strong>were<\/strong> in <\/strong>Class<\/strong> I<\/strong>–<\/strong>other risk class <\/strong>of which the<\/strong> risk class <\/strong>is now higher as per<\/strong> the MDR, <\/strong>of which<\/strong> conformity assessment <\/strong>has<\/strong> not<\/strong> been<\/strong> carried out by a Notified Body<\/strong>;<\/strong><\/p>\n <\/strong>i. If such product is:<\/p>\n – Not compliant with MDR requirements,<\/p>\n – Compliant with MDR requirements with the same barcode but not updated at ÜTS,<\/p>\n – Compliant with MDR requirements with a different barcode;<\/p>\n than it will remain registered with ÜTS until May 26, 2024. The movement of individual products registered with ÜTS will be allowed until the end of the shelf life.<\/p>\n ii. If such product is:<\/p>\n – Compliant with MDR requirements with the same barcode and updated at ÜTS,<\/p>\n – Not previously registered with ÜTS but is registered with their current documents in accordance with MDR requirements;<\/p>\n than it will be remain registered until expiration of the EC certificate. With this respect, as individual products that are compliant with either previous or current EU directives may be presented to the market, the label and user manual prepared in accordance with both the previous and the new legislation should be presented with the ÜTS registration. The movement of individual products registered with ÜTS will be allowed until the end of the shelf life. Additionally, individual product entry from EU member states will be allowed for 5 years after the expiry of the EU Declaration of Conformity.<\/p>\n In this context, all companies are required to carry out their product registration and individual product movement processes accordingly. Additionally, unlike the mentioned scenarios, concerning declarations of conformity that are already defined in the system, associated with a product in both Class I-other risk class and (i) a product in a risk class other than Class I-other or (ii) a product of which the risk class is now higher within the scope of MDR requirements, the provisions regarding Class I-other products will apply.<\/p>\n For the products that are registered with ÜTS by several companies with the same product numbers, if the product is updated pursuant to the MDR by one of these companies, others should also update such product. It has been announced that otherwise, the registration would be declined, and individual product registration would not be allowed in any way.<\/p>\n Simge K\u0131l\u0131ç, Esra Temur<\/p>\n","protected":false},"excerpt":{"rendered":"