Announcement about Products that Have Changed Class with the New Medical Device Regulation No. 2021 / KK-3

Announcement about Products that Have Changed Class with the New Medical Device Regulation No. 2021 / KK-3

As is known, the Medical Device Regulation entered into force by being published in the Official Gazette dated 02.06.2021 and numbered 31499. Various classification rules have been changed with this Regulation and this has led to a change in the risk class of some medical devices that have been introduced to the market according to the newly published regulation.

Currently 93/42/EEC directive conformity assessment by a Notified Body under the manufacturer directly placed on the market without the need for the devices that are part of the class of risk of change due to the change envisaged and related products obliged to go with a Notified Body of the class was born.

In the fifth paragraph of the Provisional Article 1 of the Regulation mentioned in the relevant issue;

“As an exception to Article 5, class I medical device in accordance with the regulations repealed by Article 110, 26/5/2021 and this regulation before the date of the declaration of conformity has been issued or a device that requires a Notified Body conformity assessment in accordance with the medical devices directive and medical devices in accordance with the regulations repealed by Article 110 and a device that has a valid certificate in accordance with the second paragraph of this article; it can be released or put into service until 26/5/2021, provided that it continues to comply with the Regulations repealed by Article 110 as of 26/5/2024 and that there are no significant changes in the design and intended use of this device until 26/5/2024.”

its provision is contained in the.

In this context, during the phase prior to the new regulation, there is not obliged to go with a Notified Body conformity assessment, as the aforementioned regulation of the products that are brought in accordance with this requirement with the relevant transitional provisions 26.05.2024 until the date will be allowed to be placed on the market, whether the product tracking system (UTs) “registered” status “Class” products to be able to keep records of transactions that need to be established for “2021/UTSG-5 class products with the announcement about the new medical device regulations changing” was released.

UTs currently “registered” in the class that is not the case within the framework of the above-mentioned considerations and the rise of “Class-” the records of the products UTs for a reference point, the information in the table in Appendix 1 a petition (see Appendix 2 for an example of the petition) ebs.titck.gov.tr a reference address is required.

The applications made will be evaluated by us and the products deemed suitable will be allowed to apply for registration from UTS.

Medical devices are announced to our companies with importance.

Reference link: https://uts.saglik.gov.tr/?p=3273