DECLARATION OF CONFORMITY TO BE PREPARED BY OUR MANUFACTURERS UNDER THE NEW MEDICAL DEVICE REGULATION
As it is known, the relevant legislation published by the European Union in accordance with the relevant provisions of the customs union agreement is harmonized in our country and applied in the same way. The "Medical Device Regulation", which was prepared in full compliance with the Medical Device Regulation (EU) 2017/745, was published in the Official Gazette dated 02.06.2021 and numbered 31499, and the "EU Declaration of Conformity", which must be prepared by the manufacturers in accordance with the Medical Device Regulation, in this direction. The information that should be in the Medical Device Regulation is included in Annex IV in the annexes part of the Medical Device Regulation.
In line with the relevant provisions of the legislation in question, our manufacturer companies will be able to prepare their Declaration of Conformity in accordance with the template documents in the annex. Relevant documents have been prepared for our companies to facilitate their business processes.
It is submitted for your information.
Statement drafts are available at the relevant announcement link.