Extension of the scope of activity of ATS to the accreditation of the body for conformity assessment of medical devices

Notification: Extension of the scope of activity of ATS to the accreditation of the body for conformity assessment of medical devices in the field covered by the Law on Medical Devices ("Official Gazette of RS", No. 105/17)

In accordance with the Rules of Accreditation and its procedures, ATS has expanded the scope of its activity to the accreditation of CABs in the field of medical devices, in accordance with the regulations adopted based on the Law on Medical Devices. The procedure of accreditation of CABs shall be carried out for the purpose of their designation (notification) or authorization in accordance with the Law on Medical Devices ("Official Gazette of RS", No. 105/17) and the Rulebook on Basic Requirements for Medical Devices ("Official Gazette of RS", No. 65/18) and the Rulebook on suspension and withdrawal, as well as on the Rulebook on technical assessment of a medical device on the market ("Official Gazette of RS", No. 99/2018, 37/2019).

For the needs of accreditation in this field of conformity assessment, the Guidance ATS-UP44 Accreditation Criteria and Guidelines for assessment of bodies for conformity assessment of medical devices, issue/revision 1/0 from 07.09.2021, has been prepared, and is also available on the ATS website. By publishing the above guidance, ATS is ready to accept and apply for accreditation/extension of the scope of accreditation for conformity assessment in accordance with the regulations adopted based on the Law on Medical Devices.

New document ATS-UP44 Accreditation Criteria and Guidelines for assessment of bodies for conformity assessment of medical devices, issue/revision 1/0 from 07.09.2021, can be found on the ATS website: HERE►

Sincerely, 
Your ATS