The Regulation Amending the Medical Devices Regulation and the Regulation Amending the In Vitro Diagnostic Medical Devices Regulation have been published in the Legal Gazette

“The Regulation Amending the Medical Devices Regulation” (“Regulation“) has introduced detailed amendments to Article 10 titled “General Obligations of the Manufacturer.”

The Regulation on notified bodies has been amended to provide for an assessment 5 years after notification and every 5 years thereafter to assess whether the notified body continues to meet the specified requirements.

Some amendments were made to the article on clinical trial application. 

Within the scope of harmonization with the European Union legislation, new regulations have been added to the mentioned legislation.

Some amendments have been made to the transitional provisions under the Regulation and new regulations have been introduced for the transition period regarding the repealed legislation.

Some amendments have been made regarding the effective periods under the Regulation.

Additions have been made to the products listed in Annex VI of the Regulation and some amendments have been made in Annex VIII regarding classification. 

The Regulation Amending the In Vitro Diagnostic Medical Devices Regulation (“In Vitro Regulation”) has also been amended and regulated in parallel with the Regulation. In this context:

Regulations on the obligations of manufacturers in the event of a pause or interruption in the supply of devices have been introduced.

The amendments made to the article of the Regulation on notified bodies are also reflected in the In Vitro Regulation.

Similar to the Regulation, new regulations have been added to the legislation specified within the scope of harmonization with the European Union legislation.

Similar to the Regulation, some amendments have been made in the transitional provisions and new regulations have been introduced for the transition period regarding the repealed legislation.

The text of the Regulation Amending the Medical Devices Regulation, which came into effect on August 17, 2024, can be accessed via this link; and the text of the Regulation Amending the In Vitro Diagnostic Medical Devices Regulation can also be accessed here.