Our company successfully completed re-notification in accordance with Council Directive No. 93/42/EEC of 14 June 1993 on medical devices in applicable version according to requirements stated in the Implementing Regulation of the Commission (EU) No. 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices as well as re-notification in accordance with the Directive of the European Parliament and the Council No. 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices in applicable version.
The currently valid Decision on Designation of our company together with the scope of designation is available at the website of the Slovak Office of Standards, Metrology and Testing.
Notification of our company in accordance with the abovementioned Decision on Designation together with the scope of notification is available at the website of the European Commission in the NANDO database.