SSCP

Access of SSCP

Class IIa implantable medical devices manufactured by UAB “Medicinos linija” have drawn up Summary of Safety and Clinical Performance (SSCP) documents. SSCP documents are intended to provide public access to an updated summary of the main aspects of the safety and clinical performance of the devices. The SSCP documents are not intended to replace the Instructions for Use as the main document to ensure the safe use of the devices, nor are they intended to provide diagnostic or therapeutic suggestions to intended users or patients. In accordance with Article 32 of Regulation (EU) 2017/745 and MDCG 2019-9 Rev. 1, the preparation of a patient-dedicated Summary of Safety and Clinical Performance (SSCP) is required only for implantable devices provided with an implant card and Class III devices intended for direct patient use. The subject devices are Class IIa medical devices intended exclusively for use by licensed dental professionals and not provided with an implant card. It is not used directly by patients. Therefore, the preparation of a patient-oriented SSCP is not applicable, and the following information is intended for users/healthcare professionals only in accordance with MDR Article 32(1).

Once the relevant EUDAMED functionality is available, SSCP documents will be made available via the European database on medical devices (EUDAMED): https://ec.europa.eu/tools/eudamed/. Until then, SSCP documents are available on manufacturer’s webpage.

To open PDF files, you may use any compatible PDF reader, for example Adobe Acrobat Reader DC. Download: https://get.adobe.com/reader/

System requirements can be found here: https://helpx.adobe.com/acrobat/system-requirements.html

Documents