TO THE KIND ATTENTION OF MEDICAL DEVICE MANUFACTURERS & IMPORTERS

As known, the Medical Device Directive (MDD-93/42) that was published on the OJLA Issue 27957 of 7 June 2011 has been repealed and replaced by the Medical Device Regulation (MDR-2017/745) as of 2 June 2021.

The new Medical Device Regulation (MDR-2017/745) of 2 June 2021 contains certain transitive provisions governing the placing on the market of products.

For implementation of these transitive provisions, ÜTSG-4[1] and ÜTSG-5[2] numbered Notices were produced and made available to all interested public for downloads on the Agency’s official website and at the PTS portal.